Chrysalis Intelligence · Sponsors · Medtronic Neuromodulation

Medtronic Neuromodulation

Minneapolis, MN, US · 1 510(k) clearances · 498 PMAs · 53 recalls

Total clearances
1
2021-08-23 → 2021-08-23
Last 12 months
0
Product codes
1
Most recent
2021-08-23
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
QQC Brain Stimulation Programming Planning Software. Class II Neurology 1 2021-08-23
Class III

PMA approvals (498)

Total PMA records
498
Originals + supplements
Distinct product codes
4
First decision
2020-01-09
Most recent
2026-09-24
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-09-24 P840001-S634 Vanta™with AdaptiveStim™ Technology - Model 977006 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2026-09-14 P970004-S458 InterStim™ Therapy System Verify™ Evaluation System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2026-09-14 P240011-S016 Altaviva™ 30-Day Notice QPT Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence Unknown
2026-09-14 P080025-S352 InterStim™ Therapy System, Verify™ Evaluation System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2026-08-21 P840001-S633 Inceptiv Implantable Neurostimulator, Vanta™ with AdaptiveStim™ Implantable Neurostimulator, Inceptiv'™ LT Implantable N 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2026-08-14 P970004-S456 InterStim™ Therapy System, Verify™ Evaluation System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2026-08-14 P840001-S631 Master Restore™, Itrel™, Synergy™, Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems and Pisces-Quad™, Spe 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2026-08-14 P240011-S015 Altaviva™ 30-Day Notice QPT Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence Unknown
2026-08-14 P080025-S350 InterStim™ Therapy System, Verify™ Evaluation System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2026-08-08 P970004-S455 InterStim™ Therapy System, Verify™ Evaluation System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2026-08-08 P840001-S630 Master Restore™; Itrel™; Synergy™; Intellis™; Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems and Pisces™; Specify™ 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2026-07-13 P240011-S010 Altaviva™ Normal 180 Day Track No User Fee QPT Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence Unknown
2026-07-01 P840001-S623 Master Restore™, Itrel™, Synergy™, Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems and Pisces™, Specify™ Normal 180 Day Track LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2026-06-16 P970004-S454 InterStim™ Therapy System, Verify™ Evaluation System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2026-06-16 P840001-S629 Master Restore™, Itrel™, Synergy™, Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems and Pisces-Quad™, Spe 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2026-06-16 P240011-S014 Altaviva™ 30-Day Notice QPT Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence Unknown
2026-06-16 P080025-S349 InterStim™ Therapy System, Verify™ Evaluation System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2026-06-12 P970004-S453 InterStim® Therapy System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2026-06-12 P080025-S348 InterStim® Therapy System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2026-06-05 P970004-S452 InterStim TM Therapy System; Verify TM Evaluation System (97800) 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2026-06-05 P840001-S628 Master Restore™; Itrel™; Synergy™; Intellis™; Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems and Pisces™; Specify™ 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2026-06-05 P080025-S347 InterStim TM Therapy System; Verify TM Evaluation System (97800) 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2026-06-04 P970004-S451 InterStim™ Therapy System; Verify™ Evaluation System; InterStim SNS Urinary Lead Model 978B1 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2026-06-04 P080025-S346 InterStim TM Therapy System; Verify™ Evaluation System; InterStim SNS Bowel Lead Model 978B1 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2026-05-22 P970004-S450 InterStim™ Therapy System; Verify™ Evaluation System (3550-05, 3560031, 3889, 978A1, 978B1) 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2026-05-22 P840001-S627 Master Restore™; Itrel™; Synergy™; Intellis™; Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems and Pisces™; Specify™ 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2026-05-22 P840001-S626 Master Restore™, Itrel™, Synergy Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems and Pisces™, Specify™, 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2026-05-22 P080025-S345 InterStim™ Therapy System; Verify™ Evaluation System (3550-05, 3560031, 3889, 978A1, 978B1) 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2026-05-20 P840001-S620 Master Restore™, Itrel™, Synergy™, Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems and Pisces™, Specify™ Real-Time Process LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2026-05-13 P840001-S625 Master Restore™, Itrel™, Synergy Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems and Pisces™, Specify™, 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2026-05-13 P240011-S013 Altaviva™ 30-Day Notice QPT Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence Unknown
2026-05-07 P970004-S448 InterStim™ Therapy System, Verify™ Evaluation System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2026-05-07 P840001-S624 Master Restore, Itrel , Synergy, Intellis , Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces-Quad, Specify, 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2026-05-07 P080025-S343 InterStim™ Therapy System, Verify™ Evaluation System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2026-05-01 P970004-S449 InterStim™ Therapy System, Verify™ Evaluation System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2026-05-01 P080025-S344 InterStim™ Therapy System, Verify™ Evaluation System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2026-04-03 P970004-S447 InterStim™ Therapy System, Verify™ Evaluation System (SNS Urinary Implantable Neurostimulators 97800, 97810) 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2026-04-03 P840001-S621 Master Intellis , Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems (SCS Implantable Neurostimulators 97716, 97715, 9 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2026-04-03 P240011-S012 Altaviva™ 30-Day Notice QPT Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence Unknown
2026-04-03 P080025-S342 InterStim™ Therapy System, Verify™ Evaluation System (SNS Bowel Implantable Neurostimulators 97800, 97810) 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2026-03-26 P240011-S011 Altaviva™ Normal 180 Day Track No User Fee QPT Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence Unknown
2026-03-18 P970004-S446 InterStim® Therapy System, Verify® Evaluation System (SNS Urinary Neurostimulator) 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2026-03-18 P080025-S341 InterStim® Therapy System, Verify® Evaluation System (SNS Bowel Neurostimulator) 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2026-02-27 P970004-S445 InterStim™ Therapy System, Verify™ Evaluation System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2026-02-27 P840001-S619 Master Restore™, Itrel™, Synergy Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems and Pisces™, Specify™, 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2026-02-27 P240011-S008 Altaviva™ 30-Day Notice QPT Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence Unknown
2026-02-27 P080025-S340 InterStim™ Therapy System, Verify™ Evaluation System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2026-02-24 P970004-S440 InterStim™ Therapy System, Verify™ Evaluation System (SNS Urinary Programming Systems A510, A511, A520, A521) Real-Time Process EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2026-02-24 P080025-S335 InterStim™ Therapy System, Verify™ Evaluation System (SNS Bowel Programming Systems A510, A511, A520, A521) Real-Time Process QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2026-02-19 P840001-S615 Master Restore, Itrel, Synerg, Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces, Specify, and Vec Real-Time Process LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2026-02-13 P840001-S609 Restore™, Itrel™, Synergy™, Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems and Pisces™, Specify™, and V 135 Review Track For 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2026-02-12 P970004-S444 SNS Urinary Neurostimulator Models 97800, 97810; SNS Urinary Screening Trialing Systems Model 3531 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2026-02-12 P840001-S617 External Neurostimulator (ENS) Model 97725; Intellis Model 97716; Intellis™ Model 97715; SCS Implantable Neurostimulator 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2026-02-12 P240011-S006 Altaviva Model P7850N 30-Day Notice QPT Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence Unknown
2026-02-12 P080025-S339 SNS Bowel Neurostimulator Models 97800, 97810; SNS Bowel Screening Trialing System Model 3531 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2026-02-11 P970004-S437 InterStim® Therapy System, Verify® Evaluation System 135 Review Track For 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2026-02-11 P840001-S608 Restore, Itrel®, Synergy®, IntellisTM and VantaTM Spinal Cord Stimulation Systems and PiscesTM, Specify®, and Vectris® S 135 Review Track For 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2026-02-11 P080025-S332 InterStim® Therapy System, Verify® Evaluation System 135 Review Track For 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2026-02-06 P840001-S618 Master Restore™, Itrel™, Synergy Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems and Pisces™, Specify™, 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2026-02-06 P240011-S007 Altaviva™ Tibial Neuromodulation System (Altaviva™ P7850N) 30-Day Notice QPT Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence Unknown
2026-01-20 P970004-S424 InterStim TM Therapy System, Verify ™ Evaluation System 135 Review Track For 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2026-01-20 P080025-S319 InterStim TM Therapy System, Verify ™ Evaluation System 135 Review Track For 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2026-01-14 P970004-S443 InterStim™ Therapy System, Verify™ Evaluation System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2026-01-14 P240011-S005 Altaviva 30-Day Notice QPT Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence Unknown
2026-01-14 P080025-S338 InterStim Therapy System, Verify Evaluation System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2025-12-23 P970004-S442 InterStim™ Therapy System, Verify™ Evaluation System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2025-12-23 P080025-S337 InterStim™ Therapy System, Verify™ Evaluation System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2025-12-22 P970004-S441 InterStim Therapy System; Verify Evaluation System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2025-12-22 P840001-S616 Master Restore; Itrel; Synergy; Intellis; Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces; Specify; and Ve 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2025-12-22 P080025-S336 InterStim Therapy System; Verify Evaluation System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2025-12-19 P240011-S004 Medtronic Altaviva System Normal 180 Day Track No User Fee QPT Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence Unknown
2025-12-18 P840001-S614 Master Restore, Itrel, Synergy Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces, Specify, and Vec 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2025-11-26 P970004-S439 InterStim Therapy System, Verify Evaluation System Normal 180 Day Track No User Fee EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2025-11-26 P840001-S613 Master Restore, Itrel, Synergy, Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces, Specify, and Ve Normal 180 Day Track No User Fee LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2025-11-26 P240011-S003 Altaviva™ Normal 180 Day Track No User Fee QPT Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence Unknown
2025-11-26 P080025-S334 InterStim™ Therapy System, Verify™ Evaluation System Normal 180 Day Track No User Fee QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2025-11-13 P840001-S610 Master Restore™, Itrel™, Synergy™, Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems and Pisces™, Specify™ Normal 180 Day Track LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2025-11-04 P970004-S426 InterStim™ Therapy System, Verify™ Evaluation System Real-Time Process EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2025-11-04 P840001-S596 Master Restore™, Itrel™, Synergy Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems and Pisces™, Specify™, Real-Time Process LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2025-11-04 P080025-S321 nterStim™ Therapy System, Verify™ Evaluation System Real-Time Process QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2025-10-23 P840001-S612 Master Restore™, Itrel™, Synergy™, Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems and Pisces-Quad™, Spe 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2025-10-21 P240011-S002 Altaviva™ Implantable Neurostimulator 30-Day Notice QPT Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence Unknown
2025-10-17 P240011-S001 Altaviva™ Implantable Neurostimulator 30-Day Notice QPT Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence Unknown
2025-10-16 P970004-S438 InterStim® Therapy System, Verify® Evaluation System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2025-10-16 P840001-S611 Restore, Itrel®, Synergy IntellisTM, VantaTM and InceptivTM Spinal Cord Stimulation Systems and PiscesTM, Specify®, and 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2025-10-16 P080025-S333 InterStim® Therapy System, Verify® Evaluation System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2025-09-18 P970004-S435 InterStim® Therapy System, Verify® Evaluation System (SNS Urinary Neurostimulator 97800); (SNS Urinary Neurostimulator I 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2025-09-18 P840001-S606 Master Restore, Itrel®, Synergy®, Intellis™ and Vanta™ Spinal Cord Stimulation Systems and Pisces™, Specify®, and Vectri 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2025-09-18 P240011 Medtronic Altaviva System Original QPT Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence Unknown
2025-09-18 P080025-S330 InterStim® Therapy System, Verify® Evaluation System (SNS Bowel Neurostimulator 97800); (SNS Bowel Neurostimulators Impl 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2025-09-15 P970004-S436 InterStim® Therapy System, Verify® Evaluation System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2025-09-15 P840001-S607 Master Restore, Itrel®, Synergy IntellisTM, VantaTM and InceptivTM Spinal Cord Stimulation Systems and PiscesTM, Specify 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2025-09-15 P080025-S331 InterStim® Therapy System, Verify® Evaluation System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2025-09-10 P970004-S421 InterStim® Therapy System 135 Review Track For 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2025-09-10 P080025-S316 InterStim® Therapy System 135 Review Track For 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2025-09-05 P970004-S434 InterStim® Therapy System; Verify® Evaluation System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2025-09-05 P840001-S605 Master Restore, Itrel®, Synergy IntellisTM, VantaTM and InceptivTM Spinal Cord Stimulation Systems and PiscesTM, Specify 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2025-09-05 P080025-S329 InterStim® Therapy System; Verify® Evaluation System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2025-08-28 P970004-S433 InterStim™ Therapy System; Verify™ Evaluation System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2025-08-28 P840001-S604 Master Restore™, Itrel™, Synergy™, Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems and Pisces-Quad™, Spe 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2025-08-28 P080025-S328 InterStim™ Therapy System; Verify™ Evaluation System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2025-08-14 P840001-S602 Master Restore™, Itrel™, Synergy™, Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems and Pisces™, Specify™ 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2025-08-06 P970004-S432 InterStim™ Therapy System, Verify™ Evaluation System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2025-08-06 P840001-S603 Master Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2025-08-06 P080025-S327 InterStim™ Therapy System, Verify™ Evaluation System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2025-08-01 P970004-S431 InterStim™ Therapy System, Verify™ Evaluation System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2025-08-01 P080025-S326 InterStim™ Therapy System, Verify™ Evaluation System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2025-07-29 P840001-S594 Model A71100 Restore Clinician Programmer Application (CPA) and Model A71200 Vanta™/Sequentia™ LT Clinician Programmer A Real-Time Process LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2025-07-28 P970004-S430 InterStim™ Therapy System; Verify™ Evaluation System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2025-07-28 P080025-S325 InterStim™ Therapy System; Verify™ Evaluation System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2025-07-22 P840001-S601 Master Restore™, Itrel™, Synergy Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems and Pisces™, Specify™, 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2025-07-17 P970004-S428 InterStim™ Therapy System, Verify™ Evaluation System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2025-07-17 P970004-S427 InterStim® Therapy System, Verify® Evaluation System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2025-07-17 P840001-S599 Master Restore™, Itrel™, Synergy™, Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems and Pisces-Quad™, Spe 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2025-07-17 P840001-S598 Master Restore, Itrel®, Synergy Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems and Pisces™, Specify®, a 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2025-07-17 P080025-S324 InterStim™ Therapy System, Verify™ Evaluation System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2025-07-17 P080025-S322 InterStim® Therapy System, Verify® Evaluation System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2025-07-16 P970004-S429 InterStim Therapy System, Verify Evaluation System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2025-07-16 P840001-S600 Restore; Itrel; Synergy Intellis; Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces; Specify; and Vectris Sp 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2025-07-16 P080025-S323 InterStim™ Therapy System, Verify™ Evaluation System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2025-07-03 P840001-S597 Master Restore™, Itrel™, Synergy™, Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems and Pisces™, Specify™ 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2025-06-18 P970004-S425 InterStim® Therapy System, Verify® Evaluation System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2025-06-18 P840001-S595 Restore, Itrel®, Synergy Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems and Pisces™, Specify®, and Vect 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2025-06-18 P080025-S320 InterStim® Therapy System, Verify® Evaluation System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2025-06-09 P840001-S591 Pain Rechargeable (RC) Spinal Cord Stimulation (SCS) System: Inceptiv LT Implantable Neurostimulator (Model 977117); Int Real-Time Process LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2025-05-21 P970004-S422 InterStim® Therapy System,Verify® Evaluation System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2025-05-21 P840001-S593 Master Restore, Itrel®, Synergy®, Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems and Pisces™, Specify®, 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2025-05-21 P080025-S317 InterStim® Therapy System, Verify® Evaluation System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2025-05-13 P970004-S423 InterStimTM Therapy System, Verify® Evaluation System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2025-05-13 P080025-S318 InterStimTM Therapy System, Verify® Evaluation System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2025-04-11 P840001-S592 Restore, Itrel®, Synergy®, IntellisTM, VantaTM and InceptivTM Spinal Cord Stimulation Systems and PiscesTM, Specify®, an 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2025-03-14 P970004-S420 InterStim® Therapy System, Verify® Evaluation System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2025-03-14 P840001-S590 Master Restore, Itrel®, Synergy®, IntellisTM and VantaTM Spinal Cord Stimulation Systems and PiscesTM, Specify®, and Vec 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2025-03-14 P080025-S315 InterStim Therapy System, Verify Evaluation System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2025-02-28 P970004-S419 InterStim® Therapy System, Verify® Evaluation System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2025-02-28 P840001-S589 Restore, Itrel®, Synergy®, IntellisTM, VantaTM and InceptivTM Spinal Cord Stimulation Systems and PiscesTM, Specify®, an 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2025-02-28 P080025-S314 InterStim® Therapy System, Verify® Evaluation System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2025-02-12 P970004-S408 InterStim Therapy System, Verify Evaluation System 135 Review Track For 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2025-02-12 P840001-S575 Restore, Itrel, Synergy, Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris S 135 Review Track For 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2025-02-12 P080025-S303 nterStim Therapy System, Verify Evaluation System 135 Review Track For 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2025-02-07 P970004-S410 InterStim® Therapy System, Verify® Evaluation System 135 Review Track For 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2025-02-07 P840001-S579 Restore, Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems, Pisces™, Specify®, and Vectris® Spinal Cord St 135 Review Track For 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2025-02-07 P080025-S305 InterStim® Therapy System, Verify® Evaluation System 135 Review Track For 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2025-01-15 P970004-S418 InterStim® Therapy System, Verify® Evaluation System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2025-01-15 P840001-S588 Restore Spinal Cord Stimulation System, Itrel® Spinal Cord Stimulation System, Intellis™ Spinal Cord Stimulation System, 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2025-01-15 P080025-S313 InterStim® Therapy System, Verify® Evaluation System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2025-01-06 P970004-S409 InterStim Therapy System, Verify Evaluation System Normal 180 Day Track EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2025-01-06 P840001-S577 Restore, Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimu Normal 180 Day Track LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2025-01-06 P080025-S304 InterStim Therapy System, Verify Evaluation System Normal 180 Day Track QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2024-12-31 P840001-S585 Restore, Itrel, Synergy Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Sp 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2024-12-23 P840001-S586 Restore, Itrel, Synergy, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2024-12-19 P970004-S416 InterStim Therapy System, Sacral Nerve Stimulation (SNS) Implantable Neurostimulator 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2024-12-19 P080025-S311 InterStim Therapy System, Sacral Nerve Stimulation (SNS) Implantable Neurostimulator 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2024-12-18 P840001-S583 Restore Spinal Cord Stimulation System, Itrel® Spinal Cord Stimulation System, Synergy® Spinal Cord Stimulation System, 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2024-12-16 P970004-S417 InterStim Therapy System, Verify Evaluation System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2024-12-16 P080025-S312 InterStim Therapy System, Verify Evaluation System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2024-12-13 P970004-S411 InterStim Therapy System Real-Time Process EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2024-12-13 P840001-S580 Sequentia LT and Vanta Spinal Cord Stimulation Systems Real-Time Process LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2024-12-13 P080025-S306 InterStim Therapy System, Verify Evaluation System Real-Time Process QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2024-12-12 P970004-S413 SNS Urinary Neurostimulator/Implantable InterStim 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2024-12-12 P840001-S581 SCS Neurostimulators Implantable Itrel Family/Restore Family 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2024-12-12 P080025-S308 SNS Bowel Neurostimulator/Implantable InterStim 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2024-12-05 P970004-S415 InterStim® Therapy System, Verify® Evaluation System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2024-12-05 P840001-S584 Master Intellis™ Spinal Cord Stimulation System, Vanta™ Spinal Cord Stimulation System, Inceptiv™ Spinal Cord Stimulati 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2024-12-05 P080025-S310 InterStim® Therapy System, Verify® Evaluation System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2024-11-25 P970004-S412 InterStim Therapy System, Verify Evaluation System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2024-11-25 P080025-S307 InterStim Therapy System, Verify Evaluation System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2024-11-18 P840001-S578 Restore, Itrel®, Synergy®, Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems, Pisces™, Specify®, and Vectr 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2024-11-05 P840001-S576 Master Restore, Itrel®, Synergy®, Intellis™ and Vanta™ Spinal Cord Stimulation Systems and Pisces™, Specify®, Vectris® S 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2024-10-28 P840001-S574 SCS Implantable Neurostimulators 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2024-10-11 P970004-S407 InterStim® Therapy System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2024-10-11 P840001-S573 Vanta™ Spinal Cord Stimulation Systems 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2024-10-11 P080025-S302 InterStim® Therapy System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2024-09-30 P970004-S406 InterStim Therapy System, Verify Evaluation System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2024-09-30 P080025-S301 InterStim Therapy System, Verify Evaluation System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2024-09-16 P970004-S405 InterStim Therapy System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2024-09-16 P840001-S572 Master Restore, Itrel® and VantaTM Spinal Cord Stimulation Systems 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2024-09-16 P840001-S571 Master Spinal Cord Stimulation (SCS) Systems 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2024-09-16 P080025-S300 InterStim Therapy System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2024-08-14 P970004-S403 InterStim Therapy System, Verify® Evaluation System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2024-08-14 P080025-S298 InterStim Therapy System, Verify Evaluation System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2024-07-31 P840001-S569 SCS Implantable Neurostimulators 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2024-07-29 P970004-S404 InterStim® Therapy System, Verify® Evaluation System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2024-07-29 P840001-S570 Intellis Spinal Cord Stimulation Systems 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2024-07-29 P080025-S299 InterStim® Therapy System, Verify® Evaluation System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2024-07-25 P840001-S568 Master Restore, Itrel, Synergy Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces, Specify, and Vec 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2024-07-25 P840001-S567 Restore, Itrel, Synergy Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Sp 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2024-07-17 P840001-S566 Inceptiv Spinal Cord Stimulation Systems 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2024-07-05 P970004-S402 InterStim Therapy System, Verify Evaluation System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2024-07-05 P080025-S297 InterStim Therapy System, Verify Evaluation System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2024-06-28 P970004-S401 InterStim® Therapy System, Verify® Evaluation System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2024-06-28 P080025-S296 InterStim® Therapy System, Verify® Evaluation System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2024-06-20 P840001-S565 Restore, Itrel, Synergy, Intellis Vanta, and Inceptiv Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris S 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2024-06-11 P970004-S397 InterStim™ Therapy System, Verify™ Evaluation System Real-Time Process EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2024-06-11 P080025-S292 InterStim Therapy System, Verify Evaluation System Real-Time Process QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2024-05-23 P970004-S400 InterStim® Therapy System, Verify® Evaluation System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2024-05-23 P840001-S564 Master Restore Spinal Cord Stimulation Systems, Itrel® Spinal Cord Stimulation Systems, Synergy® Spinal Cord Stimulation 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2024-05-23 P080025-S295 InterStim® Therapy System, Verify® Evaluation System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2024-05-10 P970004-S399 InterStim Therapy System, Verify Evaluation System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2024-05-10 P080025-S294 InterStim Therapy System, Verify Evaluation System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2024-04-26 P840001-S563 Intellis, Sequentia LT, and Vanta Spinal Cord Stimulation Systems 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2024-04-24 P970004-S398 InterStim Therapy System, Verify Evaluation System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2024-04-24 P840001-S562 Restore, Itrel, Synergy, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2024-04-24 P840001-S561 SCS Neurostimulators Implantable Itrel Family 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2024-04-24 P840001-S512 Pain Rechargeable (RC) Spinal Cord Stimulation (SCS) System: Inceptiv LT Implantable Neurostimulator (Model 977117); Int Normal 180 Day Track LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2024-04-24 P080025-S293 InterStim Therapy System, Verify Evaluation System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2024-04-09 P840001-S559 Master Restore, Itrel®, Synergy®, IntellisTM and VantaTM Spinal Cord Stimulation Systems and PiscesTM, Specify®, and Vec Real-Time Process LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2024-03-27 P970004-S395 (EZW) InterStim® Therapy System, Verify® Evaluation System Real-Time Process EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2024-03-27 P080025-S290 (QON) InterStim® Therapy System, Verify® Evaluation System Real-Time Process QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2024-02-23 P840001-S560 SCS Neurostimulator Implantable 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2024-02-22 P970004-S396 SNS Urinary Neurostimulator Implantable InterStim 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2024-02-22 P840001-S558 SCS Neurostimulators External, SCS Neurostimulators Implantable Itrel Family, SCS Neurostimulators Implantable Restore F 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2024-02-22 P080025-S291 SNS Bowel Neurostimulators Implantable InterStim 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2024-01-11 P970004-S394 InterStim® Therapy System, Verify® Evaluation System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2024-01-11 P840001-S557 Master Restore, Itrel®, Synergy®, IntellisTM and VantaTM Spinal Cord Stimulation Systems and PiscesTM, Specify®, and Vec 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2024-01-11 P080025-S289 InterStim® Therapy System, Verify® Evaluation System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2024-01-08 P840001-S527 Pain RC Spinal Cord Stimulation System (SCS) System Normal 180 Day Track LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2023-12-18 P970004-S390 InterStim Therapy System, Verify Evaluation System Normal 180 Day Track EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2023-12-18 P080025-S285 InterStim Therapy System, Verify Evaluation System Normal 180 Day Track QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2023-12-12 P970004-S392 InterStim® Therapy System, Verify® Evaluation System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2023-12-12 P840001-S550 Master Restore, Itrel®, Synergy®, IntellisTM and VantaTM Spinal Cord Stimulation Systems and PiscesTM, Specify®, and Vec Real-Time Process LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2023-12-12 P080025-S287 InterStim® Therapy System, Verify® Evaluation System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2023-11-30 P840001-S555 Master Restore, Itrel®, Synergy®, IntellisTM and VantaTM Spinal Cord Stimulation Systems and PiscesTM, Specify®, and Vec 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2023-11-29 P970004-S391 InterStim® Therapy System, Verify® Evaluation System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2023-11-29 P840001-S556 Restore, Itrel®, Synergy®, Intellis™ and Vanta™ Spinal Cord Stimulation Systems and Pisces™, Specify®, and Vectris® Spin 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2023-11-29 P840001-S549 (LGW, QRB) - Master Restore Spinal Cord Stimulation Systems Normal 180 Day Track LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2023-11-29 P080025-S286 InterStim® Therapy System, Verify® Evaluation System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2023-11-22 P970004-S393 InterStim® Therapy System, Verify® Evaluation System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2023-11-22 P970004-S385 InterStim® Therapy System, Verify® Evaluation System Normal 180 Day Track EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2023-11-22 P080025-S288 InterStim® Therapy System, Verify® Evaluation System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2023-11-22 P080025-S280 InterStim® Therapy System, Verify® Evaluation System Normal 180 Day Track QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2023-10-19 P840001-S554 Master IntellisTM and VantaTM Spinal Cord Stimulation Systems 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2023-10-19 P840001-S553 Master Intellis™ Spinal Cord Stimulation Systems 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2023-10-18 P840001-S552 Master Restore, Itrel®, Synergy®, IntellisTM and VantaTM Spinal Cord Stimulation Systems and PiscesTM, Specify®, and Vec 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2023-10-13 P970004-S387 InterStim Therapy System, Verify Evaluation System Normal 180 Day Track EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2023-10-13 P080025-S282 InterStim Therapy System, Verify Evaluation System Normal 180 Day Track QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2023-10-12 P840001-S551 Restore, Itrel®, Synergy®, Intellis™ and Vanta™ Spinal Cord Stimulation Systems and Pisces™, Specify®, Vectris® Spinal C 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2023-10-10 P840001-S544 Intellis™ and Vanta™ Spinal Cord Stimulation Systems Real-Time Process LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2023-09-22 P840001-S535 Sequentia™ LT INS (Model 977005), Vanta™ INS with AdaptiveStim™ (Model 977006) Normal 180 Day Track LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2023-09-05 P840001-S548 Master Restore, Itrel®, Synergy®, Intellis™ and Vanta™ Spinal Cord Stimulation Systems and Pisces™, Specify®, and Vectri 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2023-08-10 P970004-S389 InterStim® Therapy System, Verify® Evaluation System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2023-08-10 P970004-S388 InterStim® Therapy System, Verify® Evaluation System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2023-08-10 P840001-S547 Restore, Itrel®, Synergy®, Intellis™ and Vanta™ Spinal Cord Stimulation Systems and Pisces™, Specify®, and Vectris® Spin 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2023-08-10 P840001-S546 Master Restore, Itrel®, Synergy®, Intellis™ and Vanta™ Spinal Cord Stimulation Systems and Pisces™, Specify®, and Vectri 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2023-08-10 P080025-S284 InterStim® Therapy System, Verify® Evaluation System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2023-08-10 P080025-S283 InterStim® Therapy System, Verify® Evaluation System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2023-08-08 P840001-S529 Master Intellis Spinal Cord Stimulation Systems Normal 180 Day Track No User Fee LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2023-08-03 P970004-S386 InterStim® Therapy System, Verify® Evaluation System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2023-08-03 P840001-S545 Master Restore, Itrel®, Synergy®, Intellis™ and Vanta™ Spinal Cord Stimulation Systems and Pisces™, Specify®, and Vectri 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2023-08-03 P080025-S281 InterStim® Therapy System, Verify® Evaluation System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2023-06-21 P970004-S384 InterStim® Therapy System, Verify® Evaluation System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2023-06-21 P840001-S543 Master Restore, Itrel®, Synergy®, Intellis™ and Vanta™ Spinal Cord Stimulation Systems and Pisces™, Specify®, Vectris® S 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2023-06-21 P080025-S279 InterStim® Therapy System, Verify® Evaluation System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2023-06-14 P970004-S383 InterStim® Therapy System, Verify® Evaluation System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2023-06-14 P080025-S278 InterStim® Therapy System, Verify® Evaluation System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2023-06-02 P970004-S382 InterStim® Therapy System, Verify® Evaluation System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2023-06-02 P840001-S542 Restore, Itrel®, Synergy®, Intellis™ and Vanta™ Spinal Cord Stimulation Systems and Pisces™, Specify®, Vectris® Spinal C 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2023-06-02 P080025-S277 InterStim® Therapy System, Verify® Evaluation System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2023-05-05 P970004-S381 InterStim® Therapy System, Verify ® Evaluation System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2023-05-05 P080025-S276 InterStim® Therapy System, Verify® Evaluation System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2023-05-04 P970004-S380 InterStim® Therapy System, Verify® Evaluation System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2023-05-04 P840001-S541 - Master Restore, Itrel®, Synergy®, Intellis TM and VantaTM Spinal Cord Stimulation Systems and Pisces TM, Specify®, and 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2023-05-04 P080025-S275 InterStim® Therapy System, Verify® Evaluation System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2023-04-20 P840001-S540 Master Restore, Itrel®, Synergy®, Intellis™ and Vanta™ Spinal Cord Stimulation Systems and Pisces™, Specify®, Vectris® S 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2023-04-20 P840001-S539 Master Restore, Itrel®, Synergy®, Intellis™ and Vanta™ Spinal Cord Stimulation Systems and Pisces™, Specify®, Vectris® S 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2023-04-12 P970004-S364 InterStim Therapy System, Verify Evaluation System Normal 180 Day Track No User Fee EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2023-04-12 P080025-S259 InterStim Therapy System, Verify Evaluation System Normal 180 Day Track No User Fee QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2023-04-04 P970004-S379 InterStim® Therapy System, Verify® Evaluation System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2023-04-04 P080025-S274 InterStim® Therapy System, Verify® Evaluation System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2023-03-17 P840001-S537 Spinal Cord Stimulator (SCS) Accessories 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2023-03-16 P840001-S538 Master Restore, Itrel®, Synergy®, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify®, and Vectris® 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2023-03-14 P970004-S353 InterStim® Therapy System, Verify® Evaluation System Normal 180 Day Track EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2023-03-14 P840001-S509 Restore, Itrel®, Synergy®, Intellis™ and Vanta™ Spinal Cord Stimulation Systems Normal 180 Day Track LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2023-03-14 P080025-S248 InterStim® Therapy System, Verify® Evaluation System Normal 180 Day Track QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2023-02-02 P840001-S536 Restore and Itrel® Spinal Cord Stimulation Systems 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2022-12-08 P970004-S378 InterStim® Therapy System, Verify® Evaluation System (SNS Urinary) 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2022-12-08 P840001-S534 Itrel®, Synergy®, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify®, and Vectris® Spinal Cord Stim 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2022-12-08 P080025-S273 InterStim® Therapy System, Verify® Evaluation System (SNS Bowel) 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2022-11-22 P970004-S377 InterStim® Therapy System, Verify® Evaluation System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2022-11-22 P970004-S376 InterStim® Therapy System, Verify® Evaluation System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2022-11-22 P840001-S533 Master Restore, Itrel®, Synergy®, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify®, and Vectris® 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2022-11-22 P840001-S532 Master Restore, Itrel®, Synergy®, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify®, and Vectris® 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2022-11-22 P080025-S272 InterStim® Therapy System, Verify® Evaluation System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2022-11-22 P080025-S271 InterStim® Therapy System, Verify® Evaluation System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2022-11-16 P970004-S375 InterStim® Therapy System, Verify® Evaluation System (SNS Urinary) 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2022-11-16 P840001-S531 Master Restore, Itrel®, Synergy®, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify®, and Vectris® 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2022-11-16 P080025-S270 InterStim® Therapy System, Verify® Evaluation System (SNS Bowel) 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2022-11-02 P840001-S525 Master Restore, Itrel®, Synergy®, Intellis™, Vanta™ Spinal Cord Stimulation Systems, Pisces™, Specify®, Vectris® Spinal Real-Time Process LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2022-10-27 P970004-S374 InterStim® Therapy System, Verify® Evaluation System Special (Immediate Track) EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2022-10-27 P080025-S269 InterStim® Therapy System, Verify® Evaluation System Special (Immediate Track) QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2022-10-21 P840001-S530 Master Restore, Itrel®, Synergy®, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify®, and Vectris® 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2022-09-23 P970004-S368 InterStim® Therapy System, Verify® Evaluation System, SNS Urinary Leads Real-Time Process EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2022-09-23 P080025-S263 InterStim® Therapy System, Verify® Evaluation System, SNS Bowel Leads Real-Time Process QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2022-09-13 P970004-S373 InterStim® Therapy System, Verify® Evaluation System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2022-09-13 P840001-S528 Master Restore, Itrel®, Synergy®, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify®, and Vectris® 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2022-09-13 P080025-S268 InterStim® Therapy System, Verify® Evaluation System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2022-09-07 P840001-S526 Master Restore, Itrel®, Synergy®, IntellisTM and VantaTM Spinal Cord Stimulation Systems and PiscesTM, Specify®, and Vec 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2022-09-01 P840001-S523 Master Restore, Itrel®, Synergy®, IntellisTM Spinal Cord Stimulation Systems, PiscesTM, Specify®, Vectris® Spinal Cord S 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2022-08-30 P970004-S344 Master InterStim® Therapy System, Verify® Evaluation System Special (Immediate Track) EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2022-08-30 P080025-S239 InterStim® Therapy System, Verify® Evaluation System Special (Immediate Track) QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2022-08-26 P970004-S372 InterStim Therapy System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2022-08-26 P840001-S524 Restore, Itrel, and Synergy Spinal Cord Stimulation Systems, Pisces, Resume, Specify, and Vectris Spinal Cord Stimulatio 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2022-08-26 P080025-S267 InterStim Therapy System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2022-08-19 P970004-S367 Master InterStim Therapy System, Verify Evaluation System Real-Time Process EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2022-08-19 P080025-S262 InterStim Therapy System, Verify Evaluation System Real-Time Process QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2022-08-04 P970004-S370 InterStim® Therapy System, Verify® Evaluation System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2022-08-04 P080025-S265 InterStim® Therapy System, Verify® Evaluation System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2022-07-28 P970004-S371 InterStim® Therapy System, Verify® Evaluation System (SNS Urinary) 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2022-07-28 P840001-S522 Itrel®, Synergy®, Intellis™ and Vanta™ Spinal Cord Stimulation Systems and Pisces™, Specify®, and Vectris® Spinal Cord S 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2022-07-28 P080025-S266 InterStim® Therapy System, Verify® Evaluation System (SNS Bowel) 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2022-07-21 P840001-S514 Master Restore, Itrel, Synergy and lntellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Real-Time Process LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2022-07-08 P970004-S369 InterStim Therapy System (SNS Urinary Neurostimulator) 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2022-07-08 P080025-S264 InterStim Therapy System (SNS Bowel Neurostimulator) 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2022-06-09 P970004-S365 InterStim SNS Urinary Therapy System, Verify Evaluation System, InterStim Micro Implantable Neurostimulator 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2022-06-09 P840001-S519 Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Lea 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2022-06-09 P080025-S260 InterStim SNS Bowel Therapy System, Verify Evaluation System, InterStim Micro Implantable Neurostimulator 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2022-06-02 P840001-S521 Master Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, Vectris Spinal Cord Sti 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2022-06-01 P970004-S366 InterStim Therapy System, Verify Evaluation System, InterStim Micro Implantable Neurostimulator (SNS Urinary) 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2022-06-01 P970004-S363 InterStim Therapy System SNS Urinary Neurostimulator 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2022-06-01 P840001-S520 Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Lea 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2022-06-01 P080025-S261 InterStim Therapy System, Verify Evaluation System, InterStim Micro Implantable Neurostimulator (SNS Bowel) 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2022-06-01 P080025-S258 InterStim Therapy System SNS Bowel Neurostimulator 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2022-05-25 P840001-S518 Itrel, Synergy, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulat 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2022-05-24 P840001-S517 Master Vanta Spinal Cord Stimulation Systems 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2022-05-13 P840001-S499 Master Restore, Itrel, Synergy, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify, Vectris Spinal C Normal 180 Day Track LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2022-05-12 P970004-S362 InterStim Therapy System, Verify Evaluation System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2022-05-12 P970004-S356 InterStim® Therapy System, Verify® Evaluation System (SNS Urinary) Real-Time Process EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2022-05-12 P840001-S516 Itrel, Synergy, IntellisTM and VantaTM Spinal Cord Stimulation Systems and PiscesTM, Specify, and Vectris Spinal Cord St 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2022-05-12 P080025-S257 InterStim Therapy System, Verify Evaluation System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2022-05-12 P080025-S251 InterStim® Therapy System, Verify® Evaluation System (SNS Bowel) Real-Time Process QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2022-05-10 P970004-S361 InterStim Therapy System, Verify Evaluation System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2022-05-10 P840001-S515 Itrel, Synergy, IntellisTM and VantaTM Spinal Cord Stimulation Systems and PiscesTM, Specify, and Vectris Spinal Cord St 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2022-05-10 P080025-S256 InterStim Therapy System, Verify Evaluation System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2022-04-26 P970004-S360 InterStim® Therapy System, Verify® Evaluation System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2022-04-26 P080025-S255 InterStim® Therapy System, Verify® Evaluation System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2022-04-15 P970004-S359 InterStim Therapy System (SNS Urinary Neurostimulator Implantable InterStim) 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2022-04-15 P080025-S254 InterStim Therapy System (SNS Bowel Neurostimulators Implantable InterStim) 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2022-03-30 P970004-S357 InterStim® Therapy System, Verify® Evaluation System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2022-03-30 P840001-S513 Master Restore, Itrel®, Synergy® and Intellis Spinal Cord Stimulation Systems and Pisces, Specify®, and Vectris® Spinal 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2022-03-30 P080025-S252 InterStim® Therapy System, Verify® Evaluation System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2022-03-18 P970004-S352 InterStim Therapy System, Verify Evaluation System (SNS Urinary) Real-Time Process EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2022-03-18 P080025-S247 InterStim Therapy System, Verify Evaluation System (SNS Bowel) Real-Time Process QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2022-03-17 P970004-S358 InterStim Therapy System, Verify Evaluation System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2022-03-17 P080025-S253 InterStim Therapy System, Verify Evaluation System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2022-03-16 P970004-S343 InterStim® Therapy System, Verify® Evaluation System. 135 Review Track For 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2022-03-16 P840001-S501 Master Restore, Itrel®, Synergy® and IntellisTM Spinal Cord Stimulation Systems and PiscesTM, Specify®, and Vectris® Sp 135 Review Track For 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2022-03-16 P080025-S238 InterStim® Therapy System, Verify® Evaluation System. 135 Review Track For 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2022-03-14 P840001-S506 Master Restore, Itrel®, Synergy®, Intellis™ and Vanta™ Spinal Cord Stimulation Systems and Pisces™, Specify®, and Vectri Real-Time Process LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2022-02-26 P970004-S354 InterStim® Therapy System, Verify® Evaluation System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2022-02-26 P840001-S511 Master Restore, Itrel®, Synergy®, IntellisTM and Vanta™ Spinal Cord Stimulation Systems and Pisces, Specify®, and Vectri 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2022-02-26 P080025-S249 InterStim® Therapy System, Verify® Evaluation System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2022-02-25 P970004-S355 InterStim® Therapy System, Verify® Evaluation System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2022-02-25 P080025-S250 InterStim® Therapy System, Verify® Evaluation System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2022-02-22 P970004-S345 Master InterStim® Therapy System, Verify® Evaluation System Normal 180 Day Track EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2022-02-22 P970004-S340 InterStim™ Therapy System Normal 180 Day Track EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2022-02-22 P080025-S240 InterStim® Therapy System, Verify® Evaluation System Normal 180 Day Track QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2022-02-22 P080025-S235 InterStim™ Therapy System Normal 180 Day Track QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2022-02-18 P970004-S342 InterStim® Therapy System, Verify® Evaluation System Normal 180 Day Track EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2022-02-18 P840001-S500 Restore, Itrel®, Synergy® and Intellis™ and Vanta™ Spinal Cord Stimulation Systems and Pisces™, Specify®, and Vectris Sp Normal 180 Day Track LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2022-02-18 P080025-S237 InterStim® Therapy System, Verify® Evaluation System Normal 180 Day Track QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2022-02-17 P840001-S510 Intellis Spinal Cord Stimulation System (SCS Systems) 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2022-02-04 P840001-S508 Itrel, Synergy, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spina Cord Stimulati 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2022-02-01 P840001-S505 Master Restore, Itrel®, Synergy®, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify®, and Vectris® Normal 180 Day Track LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2022-01-21 P840001-S469 Restore, Itrel, Synergy, Intellis, and Vanta Spinal Cord Stimulation Systems, Pisces, Specify and Vectris Spinal Cord St Panel Track LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2022-01-19 P840001-S507 Master Restore, ltrel, Synergy, lntellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spin 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2022-01-13 P970004-S351 Master InterStim® Therapy System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2022-01-13 P080025-S246 InterStim® Therapy System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2021-12-15 P970004-S348 InterStim® Therapy System, Verify® Evaluation System, InterStim Micro™ Implantable Neurostimulator 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2021-12-15 P840001-S504 Master Restore, Itrel®, Synergy® and Intellis™ Spinal Cord Stimulation Systems and Pisces™, Specify®, and Vectris® Spina 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2021-12-15 P080025-S243 InterStim® Therapy System, Verify® Evaluation System, InterStim Micro™ Implantable Neurostimulator 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2021-12-08 P970004-S349 Master InterStim Therapy System, Verify Evaluation System Special (Immediate Track) EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2021-12-08 P080025-S244 InterStim Therapy System, Verify Evaluation System Special (Immediate Track) QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2021-12-03 P970004-S346 InterStim Therapy System, Verify Evaluation System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2021-12-03 P840001-S503 Master Restore, Itrel, Synergy, lntellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify, and Yectris Spin 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2021-12-03 P080025-S241 InterStim Therapy System, Verify Evaluation System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2021-12-01 P970004-S347 InterStim® Therapy System, Verify® Evaluation System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2021-12-01 P080025-S242 InterStim® Therapy System, Verify® Evaluation System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2021-10-26 P840001-S497 Restore, Itrel, Synergy, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify, Vectris Spinal Cord Sti Real-Time Process LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2021-09-01 P970004-S338 InterStim Therapy System, Verify Evaluation System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2021-09-01 P840001-S498 Master Restore, Itrel, Synergy, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify, Vectris Spinal C 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2021-09-01 P080025-S233 InterStim Therapy System, Verify Evaluation System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2021-08-30 P970004-S329 InterStim Therapy System and Verify Evaluation System (SNS Urinary) 135 Review Track For 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2021-08-30 P840001-S484 Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul 135 Review Track For 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2021-08-30 P080025-S224 InterStim Therapy System and Verify Evaluation System (SNS Bowel) 135 Review Track For 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2021-08-25 P840001-S489 Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul Real-Time Process LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2021-08-24 P970004-S341 InterStim® Therapy System, Verify® Evaluation System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2021-08-24 P080025-S236 InterStim® Therapy System, Verify® Evaluation System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2021-08-18 P970004-S339 InterStim® Therapy System, Verify® Evaluation System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2021-08-18 P080025-S234 InterStim® Therapy System, Verify® Evaluation System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2021-08-13 P970004-S337 lnterStim Therapy System, Verify Evaluation System (SNS Urinary) 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2021-08-13 P840001-S496 Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2021-08-13 P080025-S232 lnterStim Therapy System, Verify Evaluation System (SNS Bowel) 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2021-08-12 P840001-S488 Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul Real-Time Process LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2021-07-21 P970004-S335 InterStim® Therapy System, Verify® Evaluation System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2021-07-21 P840001-S492 Master Restore, Itrel®, Synergy®, Intellis™ and Vanta™ Spinal Cord Stimulation Systems and Pisces™, Specify®, and Vectri 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2021-07-21 P080025-S230 InterStim® Therapy System, Verify® Evaluation System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2021-07-15 P970004-S336 InterStim Therapy System, Verify Evaluation System (SNS Urinary) 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2021-07-15 P840001-S495 Restore, Itrel, Synergy, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2021-07-15 P080025-S231 InterStim Therapy System, Verify Evaluation System (SNS Bowel) 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2021-07-08 P840001-S491 Restore, Itrel, Synergy, Intellis, Vanta, Sequentia LT, Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2021-06-30 P840001-S493 Restore, Itrel, Synergy, Intellis , Vanta and Sequentia LT Spinal Cord Stimulation Systems and Pisces, Specify, and Vect 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2021-06-25 P970004-S334 InterStim Therapy System, Verify Evaluation System (SNS Urinary) 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2021-06-25 P840001-S490 Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2021-06-25 P080025-S229 InterStim Therapy System, Verify Evaluation System (SNS Bowel) 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2021-06-22 P970004-S333 InterStim Therapy System and Verify Evaluation System (SNS Urinary) 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2021-06-22 P080025-S228 InterStim Therapy System and Verify Evaluation System (SNS Bowel) 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2021-06-09 P840001-S471 Pain PC (Vanta™ with AdaptiveStim ™, and Sequentia™ LT) Implantable Neurostimulation Systems and Pisces, Specify, and Ve Normal 180 Day Track LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2021-06-07 P840001-S486 Restore, Itrel®, Synergy® and Intellis Spinal Cord Stimulation Systems and Pisces™, Specify®, and Vectris® Spinal Cord S Real-Time Process LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2021-05-06 P840001-S487 Itrel®, Synergy® and lntellisTM Spinal Cord Stimulation Systems and Pisces™, Specify®, and Vectris® 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2021-04-09 P970004-S332 InterStim Therapy System and Verify Evaluation System (SNS Urinary Programming Systems) 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2021-04-09 P970004-S328 InterStim Therapy System, Verify Evaluation System Real-Time Process EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2021-04-09 P080025-S227 InterStim Therapy System and Veify Evaluation System (SNS Bowel Programming Systems) 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2021-04-09 P080025-S223 InterStim Therapy System, Verify Evaluation System Real-Time Process QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2021-04-06 P970004-S331 InterStim Therapy System and Verify Evaluation System (SNS Urinary) 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2021-04-06 P840001-S485 Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris, Spinal Cord Stimu 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2021-04-06 P080025-S226 InterStim Therapy System and Verify Evaluation System (SNS Bowel) 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2021-03-31 P970004-S330 InterStim Therapy System and Verify Evaluation System (SNS Urinary) 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2021-03-31 P080025-S225 InterStim Therapy System and Verify Evaluation System (SNS Bowel) 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2021-03-05 P840001-S480 Intellis Spinal Cord Stimulation Systems; Specify and Vectris Spinal Cord Stimulation Leads; Injex lead anchors Normal 180 Day Track LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2021-02-24 P840001-S482 Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul Real-Time Process LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2021-02-10 P840001-S483 Itrel®, Synergy® and Intellis Spinal Cord Stimulation Systems and PiscesTM, Specify®, and Vectris® Spinal Cord Stimulati 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2021-02-02 P970004-S322 InterStim Therapy System and Verify Evaluation System (SNS Urinary Programming Systems) Real-Time Process EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2021-02-02 P080025-S217 InterStim Therapy System and Verify Evaluation System (SNS Bowel Programming Systems) Real-Time Process QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2021-01-29 P840001-S475 Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul Real-Time Process LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2021-01-22 P840001-S465 Intellis Spinal Cord Stimulation Systems Normal 180 Day Track No User Fee LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2021-01-08 P970004-S327 InterStim Therapy System, Verify Evaluation System (SNS Urinary) 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2021-01-08 P840001-S481 Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems, Pisces, Specify, and Vectris Spinal Cord Stimulati 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2021-01-08 P080025-S222 InterStim Therapy System, Verify Evaluation System (SNS Bowel) 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2020-12-23 P840001-S479 Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2020-12-18 P970004-S325 InterStim Therapy System, Verify Evaluation System, and InterStim Micro Implantable Neurostimulator (SNS Urinary) 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2020-12-18 P840001-S477 Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2020-12-18 P080025-S220 InterStim Therapy System, Verify Evaluation System, and InterStim Micro Implantable Neurostimulator (SNS Bowel) 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2020-12-17 P840001-S478 Intellis Spinal Cord Stimulation Systems 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2020-12-16 P970004-S326 InterStim Therapy System and Verify Evaluation System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2020-12-16 P970004-S324 InterStim SureScan MRI Leads and Percutaneous Extensions 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2020-12-16 P970004-S323 InterStim SureScan MRI Leads 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2020-12-16 P080025-S221 InterStim Therapy System and Verify Evaluation System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2020-12-16 P080025-S219 InterStim SureScan MRI Leads and Percutaneous Extensions 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2020-12-16 P080025-S218 InterStim SureScan MRI Leads 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2020-12-10 P840001-S476 Intellis Spinal Cord Stimulation Systems 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2020-11-30 P970004-S321 InterStim Therapy System, Verify Evaluation System (SNS Urinary) 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2020-11-30 P080025-S216 InterStim Therapy System, Verify Evaluation System (SNS Urinary) 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2020-11-19 P970004-S320 InterStim Therapy System, Verify Evaluation System, InterStim Micro Implantable Neurostimulator (SNS Urinary) 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2020-11-19 P840001-S473 Restore, Itrel, Synergy and Intellis, Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimu 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2020-11-19 P080025-S215 InterStim Therapy System, Verify Evaluation System, InterStim Micro Implantable Neurostimulator (SNS Bowel) 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2020-11-18 P840001-S474 Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation System and Pisces, Specify, and Vectris Spinal Cord Stimula 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2020-11-12 P970004-S319 InterStim Therapy System and Verify Evaluation System (SNS Urinary) 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2020-11-12 P970004-S318 InterStim Therapy System, Verify Evaluation System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2020-11-12 P840001-S472 Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2020-11-12 P080025-S214 InterStim Therapy System and Verify Evaluation System (SNS Bowel) 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2020-11-12 P080025-S213 InterStim Therapy System, Verify Evaluation System 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2020-11-04 P970004-S317 InterStim SureScan MRI Leads 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2020-11-04 P080025-S212 InterStim SureScan MRI Leads 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2020-11-03 P970004-S315 InterStim Therapy System, Verify Evaluation System Real-Time Process EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2020-11-03 P840001-S468 Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul Real-Time Process LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2020-11-03 P080025-S210 InterStim Therapy System, Verify Evaluation System Real-Time Process QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2020-10-01 P970004-S316 InterStim Therapy System and Verify Evaluation System (SNS Urinary) 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2020-10-01 P840001-S470 Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2020-10-01 P080025-S211 InterStim Therapy System and Verify Evaluation System (SNS Bowel) 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2020-09-09 P970004-S314 InterStim Therapy System and Verify Evaluation System (SNS Urinary) 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2020-09-09 P840001-S467 Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2020-09-09 P080025-S209 InterStim Therapy System and Verify Evaluation System (SNS Bowel) 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2020-09-06 P970004-S313 InterStim Therapy System and Verify Evaluation System (SNS Urinary) 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2020-09-06 P840001-S466 Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2020-09-06 P080025-S208 InterStim Therapy System and Verify Evaluation System (SNS Bowel) 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2020-08-17 P840001-S463 Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul Real-Time Process LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2020-07-30 P970004-S302 InterStim Therapy System and Verify Evaluation System (SNS Urinary Programming Systems) Normal 180 Day Track EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2020-07-30 P080025-S197 InterStim Therapy System and Verify Evaluation System (SNS Bowel Programming Systems) Normal 180 Day Track QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2020-07-01 P840001-S427 Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Lea Real-Time Process LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2020-06-25 P840001-S450 Restore, Itrel, Synergy, and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimu Normal 180 Day Track LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2020-06-09 P970004-S311 InterStim Therapy System and Verify Evaluation System (SNS Urinary) 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2020-06-09 P840001-S462 Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2020-06-09 P080025-S206 InterStim Therapy System and Verify Evaluation System (SNS Bowel) 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2020-05-08 P970004-S310 InterStim Therapy System, Verify Evaluation System (SNS Urinary) 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2020-05-08 P840001-S461 Restore, Itrel, Synergy, and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimu 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2020-05-08 P080025-S205 InterStim Therapy System, Verify Evaluation System (SNS Bowel) 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2020-05-07 P970004-S309 InterStim Therapy System and Verify Evaluation System (SNS Urinary) 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2020-05-07 P840001-S460 Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris, Spinal Cord Stimu 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2020-05-07 P080025-S204 InterStim Therapy System and Verify Evaluation System (SNS Bowel) 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2020-04-22 P840001-S459 Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Lea 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2020-04-07 P840001-S458 Restore,Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimula 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2020-03-27 P840001-S457 Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Lea 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2020-03-20 P970004-S308 InterStim Therapy System, Verify Evaluation System (SNS Urinary) 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2020-03-20 P840001-S456 Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Lea 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2020-03-20 P080025-S203 InterStim Therapy System, Verify Evaluation System (SNS Bowel) 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2020-03-01 P840001-S455 Restore, Itrel, Synergy, and Intellis Spinal Cord Stimulation System and Pisces, Specify, and Vectris Spinal Cord Stimul 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2020-02-20 P840001-S454 Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify and Vectris Spinal Cord Stimulation Lead 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2020-02-19 P970004-S292 InterStim Therapy System and Verify Evaluation System (SNS Urinary) Normal 180 Day Track EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2020-02-13 P080025-S187 InterStim Therapy System and Verify Evaluation System (SNS Bowel) Normal 180 Day Track QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2020-02-05 P970004-S307 InterStim Therapy System, Verify Evaluation System (SNS Urinary) 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2020-02-05 P840001-S453 Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Lea 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2020-02-05 P080025-S202 InterStim Therapy System, Verify Evaluation System (SNS Bowel) 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2020-01-09 P970004-S306 InterStim Therapy System, Verify Evaluation System (SNS Urinary) 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2020-01-09 P970004-S305 InterStim Therapy System and Verify Evaluation System (SNS Urinary) 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2020-01-09 P840001-S452 Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation systems, and Pisces, Specify, and Vectris Spinal Cord Stimu 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2020-01-09 P840001-S451 Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul 30-Day Notice LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown
2020-01-09 P080025-S201 InterStim Therapy System, Verify Evaluation System (SNS Bowel) 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
2020-01-09 P080025-S200 InterStim Therapy System and Verify Evaluation System (SNS Bowel) 30-Day Notice QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology
Safety

Recalls (53)

Class I (serious)
0
Risk of injury / death
Total recalls
53
Currently ongoing
50
Most recent
2026-05-13
DateSeverityStatusRecall # ProductCodeReason
2026-05-13 Class II Ongoing Z-2241-2026 Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Stimulator, electrical, implanted, for parkins… — A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.
2026-05-13 Class II Ongoing Z-2240-2026 Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted, for parkins… — A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.
2026-04-08 Class II Ongoing Z-2201-2026 Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on the following device… — Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode, the infusion steps should automatically be arranged in consecu…
2025-12-03 Class II Ongoing Z-1043-2026 A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683, Product number A71200. Software … — Complaints received that Vanta A71200 CP App does not function as intended during use. There is a potential for prolonged or postponed surgical procedure.
2025-11-20 Class II Ongoing Z-0996-2026 Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers: CT900A PROG CT90… — Software issue where a Device Reset message displayed on the app was unable to be cleared. In rare cases, this resulted in an inability to resume therapy, and t…
2025-04-03 Class II Ongoing Z-1704-2025 Enhanced Verify Evaluation Handset (CFN HH90130FA) — Evaluation handsets may not be able to communicate with the neurostimulator due to handsets having a faster processing speed than prior handsets. An inability t…
2025-03-04 Class II Ongoing Z-1543-2025 Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and Intellis P… — There is a software issue that can permanently disable communication with an implantable neurostimulator (INS) when a specific intraoperative programming sequen…
2025-01-09 Class II Ongoing Z-1506-2025 A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System. — Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump.
2024-11-21 Class II Ongoing Z-0774-2025 SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900E CLINICIAN TABLET GLBL SMS… — Software issues were identified in application version 2.x.
2024-11-21 Class II Ongoing Z-0773-2025 SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900D CLINICIAN TABLET GLOBAL w… — Software issues were identified in application version 2.x.
2024-11-21 Class II Ongoing Z-0772-2025 SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900C CLINICIAN TABLET UK with … — Software issues were identified in application version 2.x.
2024-11-21 Class II Ongoing Z-0771-2025 SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900B CLINICIAN TABLET EU -UK w… — Software issues were identified in application version 2.x.
2024-09-24 Class II Ongoing Z-0206-2025 Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300. — A limited number of Percept RC Implantable Neurostimulators (INS), Model B35300 will not be able to communicate with the A610 DBS Clinician Programmer Applicati…
2024-09-18 Class II Ongoing Z-0372-2025 Medtronic Recharger Kits, RS6230, RS7230, and RS5220A, containing components WR9230 and WR9220A Recharger for rechargea… — The Wireless Rechargers in the kits may be unable to enter a recharging session upon first use.
2024-09-11 Class II Ongoing Z-0137-2025 SynchroMed II Infusion Pump. Product Number: 8637-20 — Potential for error and inability to interrogate pump due to data corruption in the pump memory.
2024-08-21 Class II Ongoing Z-0132-2025 Vanta Implantable Neurostimulator (INS), Model 977006 — Model 977006 Vanta INS batterty life has depleted faster than HCPs or patients expected leading to outpatient reprogramming or earlier than anticipated surgical…
2024-06-17 Class II Ongoing Z-3073-2024 Medtronic Handset with Communicator, Model TH90Q01, InterStim Smart Programmer and Communicator Kits, containing the Mo… — A subset of the handsets within the kit may not be able to complete the pairing process with the communicator upon initial setup.
2024-05-15 Class II Ongoing Z-2427-2024 A610 Clinician Programmer (CP) Software Application (app) with the following versions: Version 2.0.x (2.0.4584, 2.0.4594… — Patients implanted with a pocket adaptor (Model 64001 and/or 64002) are limited to HEAD ONLY MRI eligibility.
2024-05-10 Class II Ongoing Z-2352-2024 Medtronic Ascenda Intrathecal Catheter, Models: a) 8780 (114 cm); b) 8781 (140 cm); c) 8784 (catheter pump revisi… — Design update to the Ascenda Intrathecal Catheter Models 8780, 8781, and 8784. The intent of the design update is to reduce the potential for tissue growth in…
2024-03-28 Class II Ongoing Z-1691-2024 Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator — inability to reprogram one device
2023-12-19 Class II Ongoing Z-0780-2024 Model A710 Intellis Clinician Programmer Application, version 2.0.97 — Medtronic has discovered an instance in which the Intellis A710 Clinician Programmer Application (CP App) could no longer establish a session with the Implantab…
2023-11-13 Class II Ongoing Z-0615-2024 Medtronic SynchroMed II, Model 8637-40, Programmable pump — Medtronic recently identified that if the SynchroMed II pump switches into telemetry mode due to electromagnetic interference (EMI) from an MRI scan, while the …
2023-11-13 Class II Ongoing Z-0614-2024 Medtronic SynchroMed II, Model 8637-20, Programmable pump — Medtronic recently identified that if the SynchroMed II pump switches into telemetry mode due to electromagnetic interference (EMI) from an MRI scan, while the …
2023-10-19 Class II Ongoing Z-0354-2024 Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators — Units distributed in Korea and Turkey that did not have the correct firmware installed to support the user interface in the local language.
2023-07-06 Class II Ongoing Z-2365-2023 Medtronic InterStim Ground Pad REF 041826 — Lot of InterStim Self-Adhesive Ground Pad is being recalled due to the product being labeled with the incorrect expiration date.
2023-06-21 Class II Ongoing Z-2226-2023 A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application.. — When an update to the A710 Clinician Programmer software application for the Intellis Neurostimulation System was released, the corresponding version of the A90…
2023-06-06 Class II Ongoing Z-2036-2023 Vanta with AdaptiveStim Implantable Neurostimulator, Model 977006; spinal chord stimulation — A cardioversion procedure may damage the electronics in the Vanta INS device, making the INS unresponsive and non-functional. As of April 19, 2023, Medtronic ha…
2023-03-17 Class II Ongoing Z-1408-2023 Medtronic SenSight Extension Tunneler Kit, REF B31030; The Extension Tunneler Kit is used to assist in the tunneling and… — Medtronic has received reports of SenSight Extension Tunneler kits that contain dual carriers with have been machined on only one side. As a result, the dual c…
2023-01-20 Class II Ongoing Z-0121-2024 SenSight Connector Plug, Model Number B31061. — Medtronic is requesting return of a small number of units of the SenSight Connector Plug, Model B31061, due to a discrepancy in the Use By Date (UBD) printed on…
2022-12-03 Class II Ongoing Z-0915-2023 Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900E — Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502", and "System Update Needed, Service Code 303"
2022-12-03 Class II Ongoing Z-0914-2023 Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900D — Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502", and "System Update Needed, Service Code 303"
2022-12-03 Class II Ongoing Z-0913-2023 Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900C — Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502", and "System Update Needed, Service Code 303"
2022-12-03 Class II Ongoing Z-0912-2023 Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900B — Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502", and "System Update Needed, Service Code 303"
2022-12-03 Class II Ongoing Z-0911-2023 Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900A — Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502", and "System Update Needed, Service Code 303"
2022-07-26 Class II Ongoing Z-1574-2022 Vanta Clinician Programmer Application, Model A71200. For programming of the Medtronic Model 977006 Vanta implantable n… — Potential communication issue in which the Vanta Clinician Programmer Application (CP App) A71200 v2.0.2455 may be unable to connect with a Vanta Implantable N…
2022-07-26 Class II Ongoing Z-1571-2022 Vanta Clinician Programmer Application, Model A71200. For programming of the Medtronic Model 977006 Vanta implantable n… — Potential for Vanta Clinician Programmer Application (CP App) A71200 v2.0.2455 to display an Unexpected Device Error Code 1502 Message, and the user will be una…
2022-05-27 Class II Completed Z-0217-2024 LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device. — There are a small number of units of the DBS Lead with StimLoc kit (3387S-40) due to a discrepancy in the Use By Date (UBD) printed on the outer packaged kit la…
2022-03-30 Class II Ongoing Z-1129-2022 Percept PC BrainSense Implantable Neurostimulator (INS) Model B35200 — The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient programmer system.
2022-03-30 Class II Ongoing Z-1128-2022 Percept BrainSense Implantable Neurostimulator (INS), Model B35200 — The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient programmer system.
2022-03-30 Class II Ongoing Z-1123-2022 Vanta INS Implantable Neurostimulator. Medtronic Model 977006 Vanta with AdaptiveStim Technology Neurostimulator with Su… — The Implantable Neurostimulator Model may be susceptible to not communicating with the clinical programmer and/or patient programmer system.
2022-02-28 Class II Ongoing Z-0998-2022 MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL, which includes the following: a) Handset with Communicator, Mod… — There is a software anomaly with the InterStim X Clinician software application with results in the data entered in the Patient Information fields not e retaine…
2021-11-04 Class II Ongoing Z-0295-2022 Medtronic Wireless Recharger Model WR9200 included in the RS7200 Recharger Kit used by the RestoreUltra (Model 37712), R… — The wireless rechargers (WR; WR9200 and WR9220; included in the Recharger Kits) become unresponsive if the charging steps, indicated in the Recharger Patient Us…
2021-11-04 Class II Ongoing Z-0294-2022 Medtronic Wireless Recharger Model WR9200 included in the RS6200 Recharger Kit used by the Activa RC (Model 37612) impla… — The wireless rechargers (WR; WR9200 and WR9220; included in the Recharger Kits) become unresponsive if the charging steps, indicated in the Recharger Patient Us…
2021-11-04 Class II Ongoing Z-0293-2022 Medtronic Wireless Recharger Model WR9220 included in the RS5200 Recharger Kit used by the InterStim Micro (Model 97810)… — The wireless rechargers (WR; WR9200 and WR9220; included in the Recharger Kits) become unresponsive if the charging steps, indicated in the Recharger Patient Us…
2021-10-19 Class II Ongoing Z-0418-2022 Model B35200 - Percept PC BrainSense Implantable Neurostimulator — During cardioversion events, the Model B35200 Percept PC Implantable Neurostimulator could become unresponsive and non-functional. Cardioversion is a procedure …
2021-09-23 Class II Ongoing Z-0201-2022 Clinician Programmer Application (CPA) model A610 Clinician Software Application — A software anomaly may occur with the clinician programmer application.
2021-07-09 Class II Ongoing Z-2159-2021 Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A290 — Specific PINs of the Vectris SureScan MRI lead kits contain the incorrect lead electrode spacing information printed on the shelf box and the sterile pack label…
2021-06-02 Class II Ongoing Z-2228-2021 Medtronic StimLoc Burr Hole Cover, Part Numbers: a) 3387S-40 b) 3389S-28 c) 3389S-40 d) 3391S-40 e) 3550S-01 f) 924256 g… — Excess nylon flash on the clip.
2021-03-25 Class II Ongoing Z-1535-2021 Intellis Model 97755 Recharger - Product Usage: designed to charge the following Medtronic rechargeable neurostimulators… — There is a potential for unintended heating that can occur with the Intellis Model 97755 Recharger.
2021-03-09 Class II Ongoing Z-1368-2021 A610 Clinician Programmer Application for Deep Brain Stimulation Clinician Programming Guide Percept PC Model B35200 Neu… — There are two issues within this correction action: 1. Cycling Issue: When copying settings from a previously used Activa device to a new Percept PC Implantab…
2020-11-19 Class II Terminated Z-0612-2021 Percept PC Implantable Neurostimulator (INS) - Product Usage: The Percept PC is a neurostimulation device for deep brain… — A software anomaly in the A620 Patient Programmer application was identified that results in failure to connect with the Percept PC device.
2020-11-12 Class II Ongoing Z-0860-2021 Medtronic Intellis Spinal Cord Stimulator, Model Number A710, Clinical Programmer application version 1.3.80 - Product U… — A710 Intellis Clinician Application has a software issue that can result in the inability to program the Intellis implantable neurostimulation device.
2020-07-17 Class II Terminated Z-2657-2023 Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators. — The original version of the A71100 Restore Clinician Programmer Application has been identified to have a compatibility issue with some legacy clinician program…
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All 510(k) clearances (1)

Date K-number Device Code Class Specialty
2021-08-23 DEN210003 SureTune4 Software QQC Class II Neurology