| 2026-08-14 |
P970004-S456 |
InterStim Therapy System, Verify Evaluation System |
30-Day Notice |
EZW |
— |
— |
| 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 |
— |
— |
| 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 |
— |
— |
| 2026-08-08 |
P970004-S455 |
InterStim Therapy System, Verify Evaluation System |
30-Day Notice |
EZW |
— |
— |
| 2026-08-08 |
P840001-S630 |
Master Restore; Itrel; Synergy; Intellis; Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces; Specify |
30-Day Notice |
LGW |
— |
— |
| 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 |
— |
— |
| 2026-06-16 |
P970004-S454 |
InterStim Therapy System, Verify Evaluation System |
30-Day Notice |
EZW |
— |
— |
| 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 |
— |
— |
| 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 |
— |
— |
| 2026-06-12 |
P970004-S453 |
InterStim® Therapy System |
30-Day Notice |
EZW |
— |
— |
| 2026-06-12 |
P080025-S348 |
InterStim® Therapy System |
30-Day Notice |
QON |
— |
— |
| 2026-06-05 |
P970004-S452 |
InterStim TM Therapy System; Verify TM Evaluation System (97800) |
30-Day Notice |
EZW |
— |
— |
| 2026-06-05 |
P840001-S628 |
Master Restore; Itrel; Synergy; Intellis; Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces; Specify |
30-Day Notice |
LGW |
— |
— |
| 2026-06-05 |
P080025-S347 |
InterStim TM Therapy System; Verify TM Evaluation System (97800) |
30-Day Notice |
QON |
— |
— |
| 2026-06-04 |
P970004-S451 |
InterStim Therapy System; Verify Evaluation System; InterStim SNS Urinary Lead Model 978B1 |
30-Day Notice |
EZW |
— |
— |
| 2026-06-04 |
P080025-S346 |
InterStim TM Therapy System; Verify Evaluation System; InterStim SNS Bowel Lead Model 978B1 |
30-Day Notice |
QON |
— |
— |
| 2026-05-22 |
P970004-S450 |
InterStim Therapy System; Verify Evaluation System (3550-05, 3560031, 3889, 978A1, 978B1) |
30-Day Notice |
EZW |
— |
— |
| 2026-05-22 |
P840001-S627 |
Master Restore; Itrel; Synergy; Intellis; Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces; Specify |
30-Day Notice |
LGW |
— |
— |
| 2026-05-22 |
P840001-S626 |
Master Restore, Itrel, Synergy Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces, Specify, |
30-Day Notice |
LGW |
— |
— |
| 2026-05-22 |
P080025-S345 |
InterStim Therapy System; Verify Evaluation System (3550-05, 3560031, 3889, 978A1, 978B1) |
30-Day Notice |
QON |
— |
— |
| 2026-05-20 |
P840001-S620 |
Master Restore, Itrel, Synergy, Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces, Specify |
Real-Time Process |
LGW |
— |
— |
| 2026-05-13 |
P840001-S625 |
Master Restore, Itrel, Synergy Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces, Specify, |
30-Day Notice |
LGW |
— |
— |
| 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 |
— |
— |
| 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 |
— |
— |
| 2026-05-07 |
P080025-S343 |
InterStim Therapy System, Verify Evaluation System |
30-Day Notice |
QON |
— |
— |
| 2026-05-01 |
P970004-S449 |
InterStim Therapy System, Verify Evaluation System |
30-Day Notice |
EZW |
— |
— |
| 2026-05-01 |
P080025-S344 |
InterStim Therapy System, Verify Evaluation System |
30-Day Notice |
QON |
— |
— |
| 2026-04-03 |
P970004-S447 |
InterStim Therapy System, Verify Evaluation System (SNS Urinary Implantable Neurostimulators 97800, 97810) |
30-Day Notice |
EZW |
— |
— |
| 2026-04-03 |
P840001-S621 |
Master Intellis , Vanta and Inceptiv Spinal Cord Stimulation Systems (SCS Implantable Neurostimulators 97716, 97715, 9 |
30-Day Notice |
LGW |
— |
— |
| 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 |
— |
— |
| 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 |
— |
— |
| 2026-03-18 |
P080025-S341 |
InterStim® Therapy System, Verify® Evaluation System (SNS Bowel Neurostimulator) |
30-Day Notice |
QON |
— |
— |
| 2026-02-27 |
P970004-S445 |
InterStim Therapy System, Verify Evaluation System |
30-Day Notice |
EZW |
— |
— |
| 2026-02-27 |
P840001-S619 |
Master Restore, Itrel, Synergy Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces, Specify, |
30-Day Notice |
LGW |
— |
— |
| 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 |
— |
— |
| 2026-02-24 |
P970004-S440 |
InterStim Therapy System, Verify Evaluation System (SNS Urinary Programming Systems A510, A511, A520, A521) |
Real-Time Process |
EZW |
— |
— |
| 2026-02-24 |
P080025-S335 |
InterStim Therapy System, Verify Evaluation System (SNS Bowel Programming Systems A510, A511, A520, A521) |
Real-Time Process |
QON |
— |
— |
| 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 |
— |
— |
| 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 |
— |
— |
| 2026-02-12 |
P970004-S444 |
SNS Urinary Neurostimulator Models 97800, 97810; SNS Urinary Screening Trialing Systems Model 3531 |
30-Day Notice |
EZW |
— |
— |
| 2026-02-12 |
P840001-S617 |
External Neurostimulator (ENS) Model 97725; Intellis Model 97716; Intellis Model 97715; SCS Implantable Neurostimulator |
30-Day Notice |
LGW |
— |
— |
| 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 |
— |
— |
| 2026-02-11 |
P970004-S437 |
InterStim® Therapy System, Verify® Evaluation System |
135 Review Track For 30-Day Notice |
EZW |
— |
— |
| 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 |
— |
— |
| 2026-02-11 |
P080025-S332 |
InterStim® Therapy System, Verify® Evaluation System |
135 Review Track For 30-Day Notice |
QON |
— |
— |
| 2026-02-06 |
P840001-S618 |
Master Restore, Itrel, Synergy Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces, Specify, |
30-Day Notice |
LGW |
— |
— |
| 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 |
— |
— |
| 2026-01-20 |
P080025-S319 |
InterStim TM Therapy System, Verify Evaluation System |
135 Review Track For 30-Day Notice |
QON |
— |
— |
| 2026-01-14 |
P970004-S443 |
InterStim Therapy System, Verify Evaluation System |
30-Day Notice |
EZW |
— |
— |
| 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 |
— |
— |
| 2025-12-23 |
P970004-S442 |
InterStim Therapy System, Verify Evaluation System |
30-Day Notice |
EZW |
— |
— |
| 2025-12-23 |
P080025-S337 |
InterStim Therapy System, Verify Evaluation System |
30-Day Notice |
QON |
— |
— |
| 2025-12-22 |
P970004-S441 |
InterStim Therapy System; Verify Evaluation System |
30-Day Notice |
EZW |
— |
— |
| 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 |
— |
— |
| 2025-12-22 |
P080025-S336 |
InterStim Therapy System; Verify Evaluation System |
30-Day Notice |
QON |
— |
— |
| 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 |
— |
— |
| 2025-11-26 |
P970004-S439 |
InterStim Therapy System, Verify Evaluation System |
Normal 180 Day Track No User Fee |
EZW |
— |
— |
| 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 |
— |
— |
| 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 |
— |
— |
| 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 |
— |
— |
| 2025-11-04 |
P970004-S426 |
InterStim Therapy System, Verify Evaluation System |
Real-Time Process |
EZW |
— |
— |
| 2025-11-04 |
P840001-S596 |
Master Restore, Itrel, Synergy Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces, Specify, |
Real-Time Process |
LGW |
— |
— |
| 2025-11-04 |
P080025-S321 |
nterStim Therapy System, Verify Evaluation System |
Real-Time Process |
QON |
— |
— |
| 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 |
— |
— |
| 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 |
— |
— |
| 2025-10-16 |
P840001-S611 |
Restore, Itrel®, Synergy IntellisTM, VantaTM and InceptivTM Spinal Cord Stimulation Systems and PiscesTM, Specify®, and |
30-Day Notice |
LGW |
— |
— |
| 2025-10-16 |
P080025-S333 |
InterStim® Therapy System, Verify® Evaluation System |
30-Day Notice |
QON |
— |
— |
| 2025-09-18 |
P970004-S435 |
InterStim® Therapy System, Verify® Evaluation System (SNS Urinary Neurostimulator 97800); (SNS Urinary Neurostimulator I |
30-Day Notice |
EZW |
— |
— |
| 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 |
— |
— |
| 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 |
— |
— |
| 2025-09-15 |
P970004-S436 |
InterStim® Therapy System, Verify® Evaluation System |
30-Day Notice |
EZW |
— |
— |
| 2025-09-15 |
P840001-S607 |
Master Restore, Itrel®, Synergy IntellisTM, VantaTM and InceptivTM Spinal Cord Stimulation Systems and PiscesTM, Specify |
30-Day Notice |
LGW |
— |
— |
| 2025-09-15 |
P080025-S331 |
InterStim® Therapy System, Verify® Evaluation System |
30-Day Notice |
QON |
— |
— |
| 2025-09-10 |
P970004-S421 |
InterStim® Therapy System |
135 Review Track For 30-Day Notice |
EZW |
— |
— |
| 2025-09-10 |
P080025-S316 |
InterStim® Therapy System |
135 Review Track For 30-Day Notice |
QON |
— |
— |
| 2025-09-05 |
P970004-S434 |
InterStim® Therapy System; Verify® Evaluation System |
30-Day Notice |
EZW |
— |
— |
| 2025-09-05 |
P840001-S605 |
Master Restore, Itrel®, Synergy IntellisTM, VantaTM and InceptivTM Spinal Cord Stimulation Systems and PiscesTM, Specify |
30-Day Notice |
LGW |
— |
— |
| 2025-09-05 |
P080025-S329 |
InterStim® Therapy System; Verify® Evaluation System |
30-Day Notice |
QON |
— |
— |
| 2025-08-28 |
P970004-S433 |
InterStim Therapy System; Verify Evaluation System |
30-Day Notice |
EZW |
— |
— |
| 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 |
— |
— |
| 2025-08-28 |
P080025-S328 |
InterStim Therapy System; Verify Evaluation System |
30-Day Notice |
QON |
— |
— |
| 2025-08-14 |
P840001-S602 |
Master Restore, Itrel, Synergy, Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces, Specify |
30-Day Notice |
LGW |
— |
— |
| 2025-08-06 |
P970004-S432 |
InterStim Therapy System, Verify Evaluation System |
30-Day Notice |
EZW |
— |
— |
| 2025-08-06 |
P840001-S603 |
Master Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems |
30-Day Notice |
LGW |
— |
— |
| 2025-08-06 |
P080025-S327 |
InterStim Therapy System, Verify Evaluation System |
30-Day Notice |
QON |
— |
— |
| 2025-08-01 |
P970004-S431 |
InterStim Therapy System, Verify Evaluation System |
30-Day Notice |
EZW |
— |
— |
| 2025-08-01 |
P080025-S326 |
InterStim Therapy System, Verify Evaluation System |
30-Day Notice |
QON |
— |
— |
| 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 |
— |
— |
| 2025-07-28 |
P970004-S430 |
InterStim Therapy System; Verify Evaluation System |
30-Day Notice |
EZW |
— |
— |
| 2025-07-28 |
P080025-S325 |
InterStim Therapy System; Verify Evaluation System |
30-Day Notice |
QON |
— |
— |
| 2025-07-22 |
P840001-S601 |
Master Restore, Itrel, Synergy Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces, Specify, |
30-Day Notice |
LGW |
— |
— |
| 2025-07-17 |
P970004-S428 |
InterStim Therapy System, Verify Evaluation System |
30-Day Notice |
EZW |
— |
— |
| 2025-07-17 |
P970004-S427 |
InterStim® Therapy System, Verify® Evaluation System |
30-Day Notice |
EZW |
— |
— |
| 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 |
— |
— |
| 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 |
— |
— |
| 2025-07-17 |
P080025-S324 |
InterStim Therapy System, Verify Evaluation System |
30-Day Notice |
QON |
— |
— |
| 2025-07-17 |
P080025-S322 |
InterStim® Therapy System, Verify® Evaluation System |
30-Day Notice |
QON |
— |
— |
| 2025-07-16 |
P970004-S429 |
InterStim Therapy System, Verify Evaluation System |
30-Day Notice |
EZW |
— |
— |
| 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 |
— |
— |
| 2025-07-16 |
P080025-S323 |
InterStim Therapy System, Verify Evaluation System |
30-Day Notice |
QON |
— |
— |
| 2025-07-03 |
P840001-S597 |
Master Restore, Itrel, Synergy, Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces, Specify |
30-Day Notice |
LGW |
— |
— |
| 2025-06-18 |
P970004-S425 |
InterStim® Therapy System, Verify® Evaluation System |
30-Day Notice |
EZW |
— |
— |
| 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 |
— |
— |
| 2025-06-18 |
P080025-S320 |
InterStim® Therapy System, Verify® Evaluation System |
30-Day Notice |
QON |
— |
— |
| 2025-06-09 |
P840001-S591 |
Pain Rechargeable (RC) Spinal Cord Stimulation (SCS) System: Inceptiv LT Implantable Neurostimulator (Model 977117); Int |
Real-Time Process |
LGW |
— |
— |
| 2025-05-21 |
P970004-S422 |
InterStim® Therapy System,Verify® Evaluation System |
30-Day Notice |
EZW |
— |
— |
| 2025-05-21 |
P840001-S593 |
Master Restore, Itrel®, Synergy®, Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces, Specify®, |
30-Day Notice |
LGW |
— |
— |
| 2025-05-21 |
P080025-S317 |
InterStim® Therapy System, Verify® Evaluation System |
30-Day Notice |
QON |
— |
— |
| 2025-05-13 |
P970004-S423 |
InterStimTM Therapy System, Verify® Evaluation System |
30-Day Notice |
EZW |
— |
— |
| 2025-05-13 |
P080025-S318 |
InterStimTM Therapy System, Verify® Evaluation System |
30-Day Notice |
QON |
— |
— |
| 2025-04-11 |
P840001-S592 |
Restore, Itrel®, Synergy®, IntellisTM, VantaTM and InceptivTM Spinal Cord Stimulation Systems and PiscesTM, Specify®, an |
30-Day Notice |
LGW |
— |
— |
| 2025-03-14 |
P970004-S420 |
InterStim® Therapy System, Verify® Evaluation System |
30-Day Notice |
EZW |
— |
— |
| 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 |
— |
— |
| 2025-03-14 |
P080025-S315 |
InterStim Therapy System, Verify Evaluation System |
30-Day Notice |
QON |
— |
— |
| 2025-02-28 |
P970004-S419 |
InterStim® Therapy System, Verify® Evaluation System |
30-Day Notice |
EZW |
— |
— |
| 2025-02-28 |
P840001-S589 |
Restore, Itrel®, Synergy®, IntellisTM, VantaTM and InceptivTM Spinal Cord Stimulation Systems and PiscesTM, Specify®, an |
30-Day Notice |
LGW |
— |
— |
| 2025-02-28 |
P080025-S314 |
InterStim® Therapy System, Verify® Evaluation System |
30-Day Notice |
QON |
— |
— |
| 2025-02-12 |
P970004-S408 |
InterStim Therapy System, Verify Evaluation System |
135 Review Track For 30-Day Notice |
EZW |
— |
— |
| 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 |
— |
— |
| 2025-02-12 |
P080025-S303 |
nterStim Therapy System, Verify Evaluation System |
135 Review Track For 30-Day Notice |
QON |
— |
— |
| 2025-02-07 |
P970004-S410 |
InterStim® Therapy System, Verify® Evaluation System |
135 Review Track For 30-Day Notice |
EZW |
— |
— |
| 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 |
— |
— |
| 2025-02-07 |
P080025-S305 |
InterStim® Therapy System, Verify® Evaluation System |
135 Review Track For 30-Day Notice |
QON |
— |
— |
| 2025-01-15 |
P970004-S418 |
InterStim® Therapy System, Verify® Evaluation System |
30-Day Notice |
EZW |
— |
— |
| 2025-01-15 |
P840001-S588 |
Restore Spinal Cord Stimulation System, Itrel® Spinal Cord Stimulation System, Intellis Spinal Cord Stimulation System, |
30-Day Notice |
LGW |
— |
— |
| 2025-01-15 |
P080025-S313 |
InterStim® Therapy System, Verify® Evaluation System |
30-Day Notice |
QON |
— |
— |
| 2025-01-06 |
P970004-S409 |
InterStim Therapy System, Verify Evaluation System |
Normal 180 Day Track |
EZW |
— |
— |
| 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 |
— |
— |
| 2025-01-06 |
P080025-S304 |
InterStim Therapy System, Verify Evaluation System |
Normal 180 Day Track |
QON |
— |
— |
| 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 |
— |
— |
| 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 |
— |
— |
| 2024-12-19 |
P970004-S416 |
InterStim Therapy System, Sacral Nerve Stimulation (SNS) Implantable Neurostimulator |
30-Day Notice |
EZW |
— |
— |
| 2024-12-19 |
P080025-S311 |
InterStim Therapy System, Sacral Nerve Stimulation (SNS) Implantable Neurostimulator |
30-Day Notice |
QON |
— |
— |
| 2024-12-18 |
P840001-S583 |
Restore Spinal Cord Stimulation System, Itrel® Spinal Cord Stimulation System, Synergy® Spinal Cord Stimulation System, |
30-Day Notice |
LGW |
— |
— |
| 2024-12-16 |
P970004-S417 |
InterStim Therapy System, Verify Evaluation System |
30-Day Notice |
EZW |
— |
— |
| 2024-12-16 |
P080025-S312 |
InterStim Therapy System, Verify Evaluation System |
30-Day Notice |
QON |
— |
— |
| 2024-12-13 |
P970004-S411 |
InterStim Therapy System |
Real-Time Process |
EZW |
— |
— |
| 2024-12-13 |
P840001-S580 |
Sequentia LT and Vanta Spinal Cord Stimulation Systems |
Real-Time Process |
LGW |
— |
— |
| 2024-12-13 |
P080025-S306 |
InterStim Therapy System, Verify Evaluation System |
Real-Time Process |
QON |
— |
— |
| 2024-12-12 |
P970004-S413 |
SNS Urinary Neurostimulator/Implantable InterStim |
30-Day Notice |
EZW |
— |
— |
| 2024-12-12 |
P840001-S581 |
SCS Neurostimulators Implantable Itrel Family/Restore Family |
30-Day Notice |
LGW |
— |
— |
| 2024-12-12 |
P080025-S308 |
SNS Bowel Neurostimulator/Implantable InterStim |
30-Day Notice |
QON |
— |
— |
| 2024-12-05 |
P970004-S415 |
InterStim® Therapy System, Verify® Evaluation System |
30-Day Notice |
EZW |
— |
— |
| 2024-12-05 |
P840001-S584 |
Master Intellis Spinal Cord Stimulation System, Vanta Spinal Cord Stimulation System, Inceptiv Spinal Cord Stimulati |
30-Day Notice |
LGW |
— |
— |
| 2024-12-05 |
P080025-S310 |
InterStim® Therapy System, Verify® Evaluation System |
30-Day Notice |
QON |
— |
— |
| 2024-11-25 |
P970004-S412 |
InterStim Therapy System, Verify Evaluation System |
30-Day Notice |
EZW |
— |
— |
| 2024-11-25 |
P080025-S307 |
InterStim Therapy System, Verify Evaluation System |
30-Day Notice |
QON |
— |
— |
| 2024-11-18 |
P840001-S578 |
Restore, Itrel®, Synergy®, Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems, Pisces, Specify®, and Vectr |
30-Day Notice |
LGW |
— |
— |
| 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 |
— |
— |
| 2024-10-28 |
P840001-S574 |
SCS Implantable Neurostimulators |
30-Day Notice |
LGW |
— |
— |
| 2024-10-11 |
P970004-S407 |
InterStim® Therapy System |
30-Day Notice |
EZW |
— |
— |
| 2024-10-11 |
P840001-S573 |
Vanta Spinal Cord Stimulation Systems |
30-Day Notice |
LGW |
— |
— |
| 2024-10-11 |
P080025-S302 |
InterStim® Therapy System |
30-Day Notice |
QON |
— |
— |
| 2024-09-30 |
P970004-S406 |
InterStim Therapy System, Verify Evaluation System |
30-Day Notice |
EZW |
— |
— |
| 2024-09-30 |
P080025-S301 |
InterStim Therapy System, Verify Evaluation System |
30-Day Notice |
QON |
— |
— |
| 2024-09-16 |
P970004-S405 |
InterStim Therapy System |
30-Day Notice |
EZW |
— |
— |
| 2024-09-16 |
P840001-S572 |
Master Restore, Itrel® and VantaTM Spinal Cord Stimulation Systems |
30-Day Notice |
LGW |
— |
— |
| 2024-09-16 |
P840001-S571 |
Master Spinal Cord Stimulation (SCS) Systems |
30-Day Notice |
LGW |
— |
— |
| 2024-09-16 |
P080025-S300 |
InterStim Therapy System |
30-Day Notice |
QON |
— |
— |
| 2024-08-14 |
P970004-S403 |
InterStim Therapy System, Verify® Evaluation System |
30-Day Notice |
EZW |
— |
— |
| 2024-08-14 |
P080025-S298 |
InterStim Therapy System, Verify Evaluation System |
30-Day Notice |
QON |
— |
— |
| 2024-07-31 |
P840001-S569 |
SCS Implantable Neurostimulators |
30-Day Notice |
LGW |
— |
— |
| 2024-07-29 |
P970004-S404 |
InterStim® Therapy System, Verify® Evaluation System |
30-Day Notice |
EZW |
— |
— |
| 2024-07-29 |
P840001-S570 |
Intellis Spinal Cord Stimulation Systems |
30-Day Notice |
LGW |
— |
— |
| 2024-07-29 |
P080025-S299 |
InterStim® Therapy System, Verify® Evaluation System |
30-Day Notice |
QON |
— |
— |
| 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 |
— |
— |
| 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 |
— |
— |
| 2024-07-17 |
P840001-S566 |
Inceptiv Spinal Cord Stimulation Systems |
30-Day Notice |
LGW |
— |
— |
| 2024-07-05 |
P970004-S402 |
InterStim Therapy System, Verify Evaluation System |
30-Day Notice |
EZW |
— |
— |
| 2024-07-05 |
P080025-S297 |
InterStim Therapy System, Verify Evaluation System |
30-Day Notice |
QON |
— |
— |
| 2024-06-28 |
P970004-S401 |
InterStim® Therapy System, Verify® Evaluation System |
30-Day Notice |
EZW |
— |
— |
| 2024-06-28 |
P080025-S296 |
InterStim® Therapy System, Verify® Evaluation System |
30-Day Notice |
QON |
— |
— |
| 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 |
— |
— |
| 2024-06-11 |
P970004-S397 |
InterStim Therapy System, Verify Evaluation System |
Real-Time Process |
EZW |
— |
— |
| 2024-06-11 |
P080025-S292 |
InterStim Therapy System, Verify Evaluation System |
Real-Time Process |
QON |
— |
— |
| 2024-05-23 |
P970004-S400 |
InterStim® Therapy System, Verify® Evaluation System |
30-Day Notice |
EZW |
— |
— |
| 2024-05-23 |
P840001-S564 |
Master Restore Spinal Cord Stimulation Systems, Itrel® Spinal Cord Stimulation Systems, Synergy® Spinal Cord Stimulation |
30-Day Notice |
LGW |
— |
— |
| 2024-05-23 |
P080025-S295 |
InterStim® Therapy System, Verify® Evaluation System |
30-Day Notice |
QON |
— |
— |
| 2024-05-10 |
P970004-S399 |
InterStim Therapy System, Verify Evaluation System |
30-Day Notice |
EZW |
— |
— |
| 2024-05-10 |
P080025-S294 |
InterStim Therapy System, Verify Evaluation System |
30-Day Notice |
QON |
— |
— |
| 2024-04-26 |
P840001-S563 |
Intellis, Sequentia LT, and Vanta Spinal Cord Stimulation Systems |
30-Day Notice |
LGW |
— |
— |
| 2024-04-24 |
P970004-S398 |
InterStim Therapy System, Verify Evaluation System |
30-Day Notice |
EZW |
— |
— |
| 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 |
— |
— |
| 2024-04-24 |
P840001-S561 |
SCS Neurostimulators Implantable Itrel Family |
30-Day Notice |
LGW |
— |
— |
| 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 |
— |
— |
| 2024-04-24 |
P080025-S293 |
InterStim Therapy System, Verify Evaluation System |
30-Day Notice |
QON |
— |
— |
| 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 |
— |
— |
| 2024-03-27 |
P970004-S395 |
(EZW) InterStim® Therapy System, Verify® Evaluation System |
Real-Time Process |
EZW |
— |
— |
| 2024-03-27 |
P080025-S290 |
(QON) InterStim® Therapy System, Verify® Evaluation System |
Real-Time Process |
QON |
— |
— |
| 2024-02-23 |
P840001-S560 |
SCS Neurostimulator Implantable |
30-Day Notice |
LGW |
— |
— |
| 2024-02-22 |
P970004-S396 |
SNS Urinary Neurostimulator Implantable InterStim |
30-Day Notice |
EZW |
— |
— |
| 2024-02-22 |
P840001-S558 |
SCS Neurostimulators External, SCS Neurostimulators Implantable Itrel Family, SCS Neurostimulators Implantable Restore F |
30-Day Notice |
LGW |
— |
— |
| 2024-02-22 |
P080025-S291 |
SNS Bowel Neurostimulators Implantable InterStim |
30-Day Notice |
QON |
— |
— |
| 2024-01-11 |
P970004-S394 |
InterStim® Therapy System, Verify® Evaluation System |
30-Day Notice |
EZW |
— |
— |
| 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 |
— |
— |
| 2024-01-11 |
P080025-S289 |
InterStim® Therapy System, Verify® Evaluation System |
30-Day Notice |
QON |
— |
— |
| 2024-01-08 |
P840001-S527 |
Pain RC Spinal Cord Stimulation System (SCS) System |
Normal 180 Day Track |
LGW |
— |
— |
| 2023-12-18 |
P970004-S390 |
InterStim Therapy System, Verify Evaluation System |
Normal 180 Day Track |
EZW |
— |
— |
| 2023-12-18 |
P080025-S285 |
InterStim Therapy System, Verify Evaluation System |
Normal 180 Day Track |
QON |
— |
— |
| 2023-12-12 |
P970004-S392 |
InterStim® Therapy System, Verify® Evaluation System |
30-Day Notice |
EZW |
— |
— |
| 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 |
— |
— |
| 2023-12-12 |
P080025-S287 |
InterStim® Therapy System, Verify® Evaluation System |
30-Day Notice |
QON |
— |
— |
| 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 |
— |
— |
| 2023-11-29 |
P970004-S391 |
InterStim® Therapy System, Verify® Evaluation System |
30-Day Notice |
EZW |
— |
— |
| 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 |
— |
— |
| 2023-11-29 |
P840001-S549 |
(LGW, QRB) - Master Restore Spinal Cord Stimulation Systems |
Normal 180 Day Track |
LGW |
— |
— |
| 2023-11-29 |
P080025-S286 |
InterStim® Therapy System, Verify® Evaluation System |
30-Day Notice |
QON |
— |
— |
| 2023-11-22 |
P970004-S393 |
InterStim® Therapy System, Verify® Evaluation System |
30-Day Notice |
EZW |
— |
— |
| 2023-11-22 |
P970004-S385 |
InterStim® Therapy System, Verify® Evaluation System |
Normal 180 Day Track |
EZW |
— |
— |
| 2023-11-22 |
P080025-S288 |
InterStim® Therapy System, Verify® Evaluation System |
30-Day Notice |
QON |
— |
— |
| 2023-11-22 |
P080025-S280 |
InterStim® Therapy System, Verify® Evaluation System |
Normal 180 Day Track |
QON |
— |
— |
| 2023-10-19 |
P840001-S554 |
Master IntellisTM and VantaTM Spinal Cord Stimulation Systems |
30-Day Notice |
LGW |
— |
— |
| 2023-10-19 |
P840001-S553 |
Master Intellis Spinal Cord Stimulation Systems |
30-Day Notice |
LGW |
— |
— |
| 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 |
— |
— |
| 2023-10-13 |
P970004-S387 |
InterStim Therapy System, Verify Evaluation System |
Normal 180 Day Track |
EZW |
— |
— |
| 2023-10-13 |
P080025-S282 |
InterStim Therapy System, Verify Evaluation System |
Normal 180 Day Track |
QON |
— |
— |
| 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 |
— |
— |
| 2023-10-10 |
P840001-S544 |
Intellis and Vanta Spinal Cord Stimulation Systems |
Real-Time Process |
LGW |
— |
— |
| 2023-09-22 |
P840001-S535 |
Sequentia LT INS (Model 977005), Vanta INS with AdaptiveStim (Model 977006) |
Normal 180 Day Track |
LGW |
— |
— |
| 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 |
— |
— |
| 2023-08-10 |
P970004-S389 |
InterStim® Therapy System, Verify® Evaluation System |
30-Day Notice |
EZW |
— |
— |
| 2023-08-10 |
P970004-S388 |
InterStim® Therapy System, Verify® Evaluation System |
30-Day Notice |
EZW |
— |
— |
| 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 |
— |
— |
| 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 |
— |
— |
| 2023-08-10 |
P080025-S284 |
InterStim® Therapy System, Verify® Evaluation System |
30-Day Notice |
QON |
— |
— |
| 2023-08-10 |
P080025-S283 |
InterStim® Therapy System, Verify® Evaluation System |
30-Day Notice |
QON |
— |
— |
| 2023-08-08 |
P840001-S529 |
Master Intellis Spinal Cord Stimulation Systems |
Normal 180 Day Track No User Fee |
LGW |
— |
— |
| 2023-08-03 |
P970004-S386 |
InterStim® Therapy System, Verify® Evaluation System |
30-Day Notice |
EZW |
— |
— |
| 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 |
— |
— |
| 2023-08-03 |
P080025-S281 |
InterStim® Therapy System, Verify® Evaluation System |
30-Day Notice |
QON |
— |
— |
| 2023-06-21 |
P970004-S384 |
InterStim® Therapy System, Verify® Evaluation System |
30-Day Notice |
EZW |
— |
— |
| 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 |
— |
— |
| 2023-06-21 |
P080025-S279 |
InterStim® Therapy System, Verify® Evaluation System |
30-Day Notice |
QON |
— |
— |
| 2023-06-14 |
P970004-S383 |
InterStim® Therapy System, Verify® Evaluation System |
30-Day Notice |
EZW |
— |
— |
| 2023-06-14 |
P080025-S278 |
InterStim® Therapy System, Verify® Evaluation System |
30-Day Notice |
QON |
— |
— |
| 2023-06-02 |
P970004-S382 |
InterStim® Therapy System, Verify® Evaluation System |
30-Day Notice |
EZW |
— |
— |
| 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 |
— |
— |
| 2023-06-02 |
P080025-S277 |
InterStim® Therapy System, Verify® Evaluation System |
30-Day Notice |
QON |
— |
— |
| 2023-05-05 |
P970004-S381 |
InterStim® Therapy System, Verify ® Evaluation System |
30-Day Notice |
EZW |
— |
— |
| 2023-05-05 |
P080025-S276 |
InterStim® Therapy System, Verify® Evaluation System |
30-Day Notice |
QON |
— |
— |
| 2023-05-04 |
P970004-S380 |
InterStim® Therapy System, Verify® Evaluation System |
30-Day Notice |
EZW |
— |
— |
| 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 |
— |
— |
| 2023-05-04 |
P080025-S275 |
InterStim® Therapy System, Verify® Evaluation System |
30-Day Notice |
QON |
— |
— |
| 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 |
— |
— |
| 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 |
— |
— |
| 2023-04-12 |
P970004-S364 |
InterStim Therapy System, Verify Evaluation System |
Normal 180 Day Track No User Fee |
EZW |
— |
— |
| 2023-04-12 |
P080025-S259 |
InterStim Therapy System, Verify Evaluation System |
Normal 180 Day Track No User Fee |
QON |
— |
— |
| 2023-04-04 |
P970004-S379 |
InterStim® Therapy System, Verify® Evaluation System |
30-Day Notice |
EZW |
— |
— |
| 2023-04-04 |
P080025-S274 |
InterStim® Therapy System, Verify® Evaluation System |
30-Day Notice |
QON |
— |
— |
| 2023-03-17 |
P840001-S537 |
Spinal Cord Stimulator (SCS) Accessories |
30-Day Notice |
LGW |
— |
— |
| 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 |
— |
— |
| 2023-03-14 |
P970004-S353 |
InterStim® Therapy System, Verify® Evaluation System |
Normal 180 Day Track |
EZW |
— |
— |
| 2023-03-14 |
P840001-S509 |
Restore, Itrel®, Synergy®, Intellis and Vanta Spinal Cord Stimulation Systems |
Normal 180 Day Track |
LGW |
— |
— |
| 2023-03-14 |
P080025-S248 |
InterStim® Therapy System, Verify® Evaluation System |
Normal 180 Day Track |
QON |
— |
— |
| 2023-02-02 |
P840001-S536 |
Restore and Itrel® Spinal Cord Stimulation Systems |
30-Day Notice |
LGW |
— |
— |
| 2022-12-08 |
P970004-S378 |
InterStim® Therapy System, Verify® Evaluation System (SNS Urinary) |
30-Day Notice |
EZW |
— |
— |
| 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 |
— |
— |
| 2022-12-08 |
P080025-S273 |
InterStim® Therapy System, Verify® Evaluation System (SNS Bowel) |
30-Day Notice |
QON |
— |
— |
| 2022-11-22 |
P970004-S377 |
InterStim® Therapy System, Verify® Evaluation System |
30-Day Notice |
EZW |
— |
— |
| 2022-11-22 |
P970004-S376 |
InterStim® Therapy System, Verify® Evaluation System |
30-Day Notice |
EZW |
— |
— |
| 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 |
— |
— |
| 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 |
— |
— |
| 2022-11-22 |
P080025-S272 |
InterStim® Therapy System, Verify® Evaluation System |
30-Day Notice |
QON |
— |
— |
| 2022-11-22 |
P080025-S271 |
InterStim® Therapy System, Verify® Evaluation System |
30-Day Notice |
QON |
— |
— |
| 2022-11-16 |
P970004-S375 |
InterStim® Therapy System, Verify® Evaluation System (SNS Urinary) |
30-Day Notice |
EZW |
— |
— |
| 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 |
— |
— |
| 2022-11-16 |
P080025-S270 |
InterStim® Therapy System, Verify® Evaluation System (SNS Bowel) |
30-Day Notice |
QON |
— |
— |
| 2022-11-02 |
P840001-S525 |
Master Restore, Itrel®, Synergy®, Intellis, Vanta Spinal Cord Stimulation Systems, Pisces, Specify®, Vectris® Spinal |
Real-Time Process |
LGW |
— |
— |
| 2022-10-27 |
P970004-S374 |
InterStim® Therapy System, Verify® Evaluation System |
Special (Immediate Track) |
EZW |
— |
— |
| 2022-10-27 |
P080025-S269 |
InterStim® Therapy System, Verify® Evaluation System |
Special (Immediate Track) |
QON |
— |
— |
| 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 |
— |
— |
| 2022-09-23 |
P970004-S368 |
InterStim® Therapy System, Verify® Evaluation System, SNS Urinary Leads |
Real-Time Process |
EZW |
— |
— |
| 2022-09-23 |
P080025-S263 |
InterStim® Therapy System, Verify® Evaluation System, SNS Bowel Leads |
Real-Time Process |
QON |
— |
— |
| 2022-09-13 |
P970004-S373 |
InterStim® Therapy System, Verify® Evaluation System |
30-Day Notice |
EZW |
— |
— |
| 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 |
— |
— |
| 2022-09-13 |
P080025-S268 |
InterStim® Therapy System, Verify® Evaluation System |
30-Day Notice |
QON |
— |
— |
| 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 |
— |
— |
| 2022-09-01 |
P840001-S523 |
Master Restore, Itrel®, Synergy®, IntellisTM Spinal Cord Stimulation Systems, PiscesTM, Specify®, Vectris® Spinal Cord S |
30-Day Notice |
LGW |
— |
— |
| 2022-08-30 |
P970004-S344 |
Master InterStim® Therapy System, Verify® Evaluation System |
Special (Immediate Track) |
EZW |
— |
— |
| 2022-08-30 |
P080025-S239 |
InterStim® Therapy System, Verify® Evaluation System |
Special (Immediate Track) |
QON |
— |
— |
| 2022-08-26 |
P970004-S372 |
InterStim Therapy System |
30-Day Notice |
EZW |
— |
— |
| 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 |
— |
— |
| 2022-08-26 |
P080025-S267 |
InterStim Therapy System |
30-Day Notice |
QON |
— |
— |
| 2022-08-19 |
P970004-S367 |
Master InterStim Therapy System, Verify Evaluation System |
Real-Time Process |
EZW |
— |
— |
| 2022-08-19 |
P080025-S262 |
InterStim Therapy System, Verify Evaluation System |
Real-Time Process |
QON |
— |
— |
| 2022-08-04 |
P970004-S370 |
InterStim® Therapy System, Verify® Evaluation System |
30-Day Notice |
EZW |
— |
— |
| 2022-08-04 |
P080025-S265 |
InterStim® Therapy System, Verify® Evaluation System |
30-Day Notice |
QON |
— |
— |
| 2022-07-28 |
P970004-S371 |
InterStim® Therapy System, Verify® Evaluation System (SNS Urinary) |
30-Day Notice |
EZW |
— |
— |
| 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 |
— |
— |
| 2022-07-28 |
P080025-S266 |
InterStim® Therapy System, Verify® Evaluation System (SNS Bowel) |
30-Day Notice |
QON |
— |
— |
| 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 |
— |
— |
| 2022-07-08 |
P970004-S369 |
InterStim Therapy System (SNS Urinary Neurostimulator) |
30-Day Notice |
EZW |
— |
— |
| 2022-07-08 |
P080025-S264 |
InterStim Therapy System (SNS Bowel Neurostimulator) |
30-Day Notice |
QON |
— |
— |
| 2022-06-09 |
P970004-S365 |
InterStim SNS Urinary Therapy System, Verify Evaluation System, InterStim Micro Implantable Neurostimulator |
30-Day Notice |
EZW |
— |
— |
| 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 |
— |
— |
| 2022-06-09 |
P080025-S260 |
InterStim SNS Bowel Therapy System, Verify Evaluation System, InterStim Micro Implantable Neurostimulator |
30-Day Notice |
QON |
— |
— |
| 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 |
— |
— |
| 2022-06-01 |
P970004-S366 |
InterStim Therapy System, Verify Evaluation System, InterStim Micro Implantable Neurostimulator (SNS Urinary) |
30-Day Notice |
EZW |
— |
— |
| 2022-06-01 |
P970004-S363 |
InterStim Therapy System SNS Urinary Neurostimulator |
30-Day Notice |
EZW |
— |
— |
| 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 |
— |
— |
| 2022-06-01 |
P080025-S261 |
InterStim Therapy System, Verify Evaluation System, InterStim Micro Implantable Neurostimulator (SNS Bowel) |
30-Day Notice |
QON |
— |
— |
| 2022-06-01 |
P080025-S258 |
InterStim Therapy System SNS Bowel Neurostimulator |
30-Day Notice |
QON |
— |
— |
| 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 |
— |
— |
| 2022-05-24 |
P840001-S517 |
Master Vanta Spinal Cord Stimulation Systems |
30-Day Notice |
LGW |
— |
— |
| 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 |
— |
— |
| 2022-05-12 |
P970004-S362 |
InterStim Therapy System, Verify Evaluation System |
30-Day Notice |
EZW |
— |
— |
| 2022-05-12 |
P970004-S356 |
InterStim® Therapy System, Verify® Evaluation System (SNS Urinary) |
Real-Time Process |
EZW |
— |
— |
| 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 |
— |
— |
| 2022-05-12 |
P080025-S257 |
InterStim Therapy System, Verify Evaluation System |
30-Day Notice |
QON |
— |
— |
| 2022-05-12 |
P080025-S251 |
InterStim® Therapy System, Verify® Evaluation System (SNS Bowel) |
Real-Time Process |
QON |
— |
— |
| 2022-05-10 |
P970004-S361 |
InterStim Therapy System, Verify Evaluation System |
30-Day Notice |
EZW |
— |
— |
| 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 |
— |
— |
| 2022-05-10 |
P080025-S256 |
InterStim Therapy System, Verify Evaluation System |
30-Day Notice |
QON |
— |
— |
| 2022-04-26 |
P970004-S360 |
InterStim® Therapy System, Verify® Evaluation System |
30-Day Notice |
EZW |
— |
— |
| 2022-04-26 |
P080025-S255 |
InterStim® Therapy System, Verify® Evaluation System |
30-Day Notice |
QON |
— |
— |
| 2022-04-15 |
P970004-S359 |
InterStim Therapy System (SNS Urinary Neurostimulator Implantable InterStim) |
30-Day Notice |
EZW |
— |
— |
| 2022-04-15 |
P080025-S254 |
InterStim Therapy System (SNS Bowel Neurostimulators Implantable InterStim) |
30-Day Notice |
QON |
— |
— |
| 2022-03-30 |
P970004-S357 |
InterStim® Therapy System, Verify® Evaluation System |
30-Day Notice |
EZW |
— |
— |
| 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 |
— |
— |
| 2022-03-30 |
P080025-S252 |
InterStim® Therapy System, Verify® Evaluation System |
30-Day Notice |
QON |
— |
— |
| 2022-03-18 |
P970004-S352 |
InterStim Therapy System, Verify Evaluation System (SNS Urinary) |
Real-Time Process |
EZW |
— |
— |
| 2022-03-18 |
P080025-S247 |
InterStim Therapy System, Verify Evaluation System (SNS Bowel) |
Real-Time Process |
QON |
— |
— |
| 2022-03-17 |
P970004-S358 |
InterStim Therapy System, Verify Evaluation System |
30-Day Notice |
EZW |
— |
— |
| 2022-03-17 |
P080025-S253 |
InterStim Therapy System, Verify Evaluation System |
30-Day Notice |
QON |
— |
— |
| 2022-03-16 |
P970004-S343 |
InterStim® Therapy System, Verify® Evaluation System. |
135 Review Track For 30-Day Notice |
EZW |
— |
— |
| 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 |
— |
— |
| 2022-03-16 |
P080025-S238 |
InterStim® Therapy System, Verify® Evaluation System. |
135 Review Track For 30-Day Notice |
QON |
— |
— |
| 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 |
— |
— |
| 2022-02-26 |
P970004-S354 |
InterStim® Therapy System, Verify® Evaluation System |
30-Day Notice |
EZW |
— |
— |
| 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 |
— |
— |
| 2022-02-26 |
P080025-S249 |
InterStim® Therapy System, Verify® Evaluation System |
30-Day Notice |
QON |
— |
— |
| 2022-02-25 |
P970004-S355 |
InterStim® Therapy System, Verify® Evaluation System |
30-Day Notice |
EZW |
— |
— |
| 2022-02-25 |
P080025-S250 |
InterStim® Therapy System, Verify® Evaluation System |
30-Day Notice |
QON |
— |
— |
| 2022-02-22 |
P970004-S345 |
Master InterStim® Therapy System, Verify® Evaluation System |
Normal 180 Day Track |
EZW |
— |
— |
| 2022-02-22 |
P970004-S340 |
InterStim Therapy System |
Normal 180 Day Track |
EZW |
— |
— |
| 2022-02-22 |
P080025-S240 |
InterStim® Therapy System, Verify® Evaluation System |
Normal 180 Day Track |
QON |
— |
— |
| 2022-02-22 |
P080025-S235 |
InterStim Therapy System |
Normal 180 Day Track |
QON |
— |
— |
| 2022-02-18 |
P970004-S342 |
InterStim® Therapy System, Verify® Evaluation System |
Normal 180 Day Track |
EZW |
— |
— |
| 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 |
— |
— |
| 2022-02-18 |
P080025-S237 |
InterStim® Therapy System, Verify® Evaluation System |
Normal 180 Day Track |
QON |
— |
— |
| 2022-02-17 |
P840001-S510 |
Intellis Spinal Cord Stimulation System (SCS Systems) |
30-Day Notice |
LGW |
— |
— |
| 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 |
— |
— |
| 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 |
— |
— |
| 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 |
— |
— |
| 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 |
— |
— |
| 2022-01-13 |
P970004-S351 |
Master InterStim® Therapy System |
30-Day Notice |
EZW |
— |
— |
| 2022-01-13 |
P080025-S246 |
InterStim® Therapy System |
30-Day Notice |
QON |
— |
— |
| 2021-12-15 |
P970004-S348 |
InterStim® Therapy System, Verify® Evaluation System, InterStim Micro Implantable Neurostimulator |
30-Day Notice |
EZW |
— |
— |
| 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 |
— |
— |
| 2021-12-15 |
P080025-S243 |
InterStim® Therapy System, Verify® Evaluation System, InterStim Micro Implantable Neurostimulator |
30-Day Notice |
QON |
— |
— |
| 2021-12-08 |
P970004-S349 |
Master InterStim Therapy System, Verify Evaluation System |
Special (Immediate Track) |
EZW |
— |
— |
| 2021-12-08 |
P080025-S244 |
InterStim Therapy System, Verify Evaluation System |
Special (Immediate Track) |
QON |
— |
— |
| 2021-12-03 |
P970004-S346 |
InterStim Therapy System, Verify Evaluation System |
30-Day Notice |
EZW |
— |
— |
| 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 |
— |
— |
| 2021-12-03 |
P080025-S241 |
InterStim Therapy System, Verify Evaluation System |
30-Day Notice |
QON |
— |
— |
| 2021-12-01 |
P970004-S347 |
InterStim® Therapy System, Verify® Evaluation System |
30-Day Notice |
EZW |
— |
— |
| 2021-12-01 |
P080025-S242 |
InterStim® Therapy System, Verify® Evaluation System |
30-Day Notice |
QON |
— |
— |
| 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 |
— |
— |
| 2021-09-01 |
P970004-S338 |
InterStim Therapy System, Verify Evaluation System |
30-Day Notice |
EZW |
— |
— |
| 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 |
— |
— |
| 2021-09-01 |
P080025-S233 |
InterStim Therapy System, Verify Evaluation System |
30-Day Notice |
QON |
— |
— |
| 2021-08-30 |
P970004-S329 |
InterStim Therapy System and Verify Evaluation System (SNS Urinary) |
135 Review Track For 30-Day Notice |
EZW |
— |
— |
| 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 |
— |
— |
| 2021-08-30 |
P080025-S224 |
InterStim Therapy System and Verify Evaluation System (SNS Bowel) |
135 Review Track For 30-Day Notice |
QON |
— |
— |
| 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 |
— |
— |
| 2021-08-24 |
P970004-S341 |
InterStim® Therapy System, Verify® Evaluation System |
30-Day Notice |
EZW |
— |
— |
| 2021-08-24 |
P080025-S236 |
InterStim® Therapy System, Verify® Evaluation System |
30-Day Notice |
QON |
— |
— |
| 2021-08-18 |
P970004-S339 |
InterStim® Therapy System, Verify® Evaluation System |
30-Day Notice |
EZW |
— |
— |
| 2021-08-18 |
P080025-S234 |
InterStim® Therapy System, Verify® Evaluation System |
30-Day Notice |
QON |
— |
— |
| 2021-08-13 |
P970004-S337 |
lnterStim Therapy System, Verify Evaluation System (SNS Urinary) |
30-Day Notice |
EZW |
— |
— |
| 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 |
— |
— |
| 2021-08-13 |
P080025-S232 |
lnterStim Therapy System, Verify Evaluation System (SNS Bowel) |
30-Day Notice |
QON |
— |
— |
| 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 |
— |
— |
| 2021-07-21 |
P970004-S335 |
InterStim® Therapy System, Verify® Evaluation System |
30-Day Notice |
EZW |
— |
— |
| 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 |
— |
— |
| 2021-07-21 |
P080025-S230 |
InterStim® Therapy System, Verify® Evaluation System |
30-Day Notice |
QON |
— |
— |
| 2021-07-15 |
P970004-S336 |
InterStim Therapy System, Verify Evaluation System (SNS Urinary) |
30-Day Notice |
EZW |
— |
— |
| 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 |
— |
— |
| 2021-07-15 |
P080025-S231 |
InterStim Therapy System, Verify Evaluation System (SNS Bowel) |
30-Day Notice |
QON |
— |
— |
| 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 |
— |
— |
| 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 |
— |
— |
| 2021-06-25 |
P970004-S334 |
InterStim Therapy System, Verify Evaluation System (SNS Urinary) |
30-Day Notice |
EZW |
— |
— |
| 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 |
— |
— |
| 2021-06-25 |
P080025-S229 |
InterStim Therapy System, Verify Evaluation System (SNS Bowel) |
30-Day Notice |
QON |
— |
— |
| 2021-06-22 |
P970004-S333 |
InterStim Therapy System and Verify Evaluation System (SNS Urinary) |
30-Day Notice |
EZW |
— |
— |
| 2021-06-22 |
P080025-S228 |
InterStim Therapy System and Verify Evaluation System (SNS Bowel) |
30-Day Notice |
QON |
— |
— |
| 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 |
— |
— |
| 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 |
— |
— |
| 2021-05-06 |
P840001-S487 |
Itrel®, Synergy® and lntellisTM Spinal Cord Stimulation Systems and Pisces, Specify®, and Vectris® |
30-Day Notice |
LGW |
— |
— |
| 2021-04-09 |
P970004-S332 |
InterStim Therapy System and Verify Evaluation System (SNS Urinary Programming Systems) |
30-Day Notice |
EZW |
— |
— |
| 2021-04-09 |
P970004-S328 |
InterStim Therapy System, Verify Evaluation System |
Real-Time Process |
EZW |
— |
— |
| 2021-04-09 |
P080025-S227 |
InterStim Therapy System and Veify Evaluation System (SNS Bowel Programming Systems) |
30-Day Notice |
QON |
— |
— |
| 2021-04-09 |
P080025-S223 |
InterStim Therapy System, Verify Evaluation System |
Real-Time Process |
QON |
— |
— |
| 2021-04-06 |
P970004-S331 |
InterStim Therapy System and Verify Evaluation System (SNS Urinary) |
30-Day Notice |
EZW |
— |
— |
| 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 |
— |
— |
| 2021-04-06 |
P080025-S226 |
InterStim Therapy System and Verify Evaluation System (SNS Bowel) |
30-Day Notice |
QON |
— |
— |
| 2021-03-31 |
P970004-S330 |
InterStim Therapy System and Verify Evaluation System (SNS Urinary) |
30-Day Notice |
EZW |
— |
— |
| 2021-03-31 |
P080025-S225 |
InterStim Therapy System and Verify Evaluation System (SNS Bowel) |
30-Day Notice |
QON |
— |
— |
| 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 |
— |
— |
| 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 |
— |
— |
| 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 |
— |
— |
| 2021-02-02 |
P970004-S322 |
InterStim Therapy System and Verify Evaluation System (SNS Urinary Programming Systems) |
Real-Time Process |
EZW |
— |
— |
| 2021-02-02 |
P080025-S217 |
InterStim Therapy System and Verify Evaluation System (SNS Bowel Programming Systems) |
Real-Time Process |
QON |
— |
— |
| 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 |
— |
— |
| 2021-01-22 |
P840001-S465 |
Intellis Spinal Cord Stimulation Systems |
Normal 180 Day Track No User Fee |
LGW |
— |
— |
| 2021-01-08 |
P970004-S327 |
InterStim Therapy System, Verify Evaluation System (SNS Urinary) |
30-Day Notice |
EZW |
— |
— |
| 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 |
— |
— |
| 2021-01-08 |
P080025-S222 |
InterStim Therapy System, Verify Evaluation System (SNS Bowel) |
30-Day Notice |
QON |
— |
— |
| 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 |
— |
— |
| 2020-12-18 |
P970004-S325 |
InterStim Therapy System, Verify Evaluation System, and InterStim Micro Implantable Neurostimulator (SNS Urinary) |
30-Day Notice |
EZW |
— |
— |
| 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 |
— |
— |
| 2020-12-18 |
P080025-S220 |
InterStim Therapy System, Verify Evaluation System, and InterStim Micro Implantable Neurostimulator (SNS Bowel) |
30-Day Notice |
QON |
— |
— |
| 2020-12-17 |
P840001-S478 |
Intellis Spinal Cord Stimulation Systems |
30-Day Notice |
LGW |
— |
— |
| 2020-12-16 |
P970004-S326 |
InterStim Therapy System and Verify Evaluation System |
30-Day Notice |
EZW |
— |
— |
| 2020-12-16 |
P970004-S324 |
InterStim SureScan MRI Leads and Percutaneous Extensions |
30-Day Notice |
EZW |
— |
— |
| 2020-12-16 |
P970004-S323 |
InterStim SureScan MRI Leads |
30-Day Notice |
EZW |
— |
— |
| 2020-12-16 |
P080025-S221 |
InterStim Therapy System and Verify Evaluation System |
30-Day Notice |
QON |
— |
— |
| 2020-12-16 |
P080025-S219 |
InterStim SureScan MRI Leads and Percutaneous Extensions |
30-Day Notice |
QON |
— |
— |
| 2020-12-16 |
P080025-S218 |
InterStim SureScan MRI Leads |
30-Day Notice |
QON |
— |
— |
| 2020-12-10 |
P840001-S476 |
Intellis Spinal Cord Stimulation Systems |
30-Day Notice |
LGW |
— |
— |
| 2020-11-30 |
P970004-S321 |
InterStim Therapy System, Verify Evaluation System (SNS Urinary) |
30-Day Notice |
EZW |
— |
— |
| 2020-11-30 |
P080025-S216 |
InterStim Therapy System, Verify Evaluation System (SNS Urinary) |
30-Day Notice |
QON |
— |
— |
| 2020-11-19 |
P970004-S320 |
InterStim Therapy System, Verify Evaluation System, InterStim Micro Implantable Neurostimulator (SNS Urinary) |
30-Day Notice |
EZW |
— |
— |
| 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 |
— |
— |
| 2020-11-19 |
P080025-S215 |
InterStim Therapy System, Verify Evaluation System, InterStim Micro Implantable Neurostimulator (SNS Bowel) |
30-Day Notice |
QON |
— |
— |
| 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 |
— |
— |
| 2020-11-12 |
P970004-S319 |
InterStim Therapy System and Verify Evaluation System (SNS Urinary) |
30-Day Notice |
EZW |
— |
— |
| 2020-11-12 |
P970004-S318 |
InterStim Therapy System, Verify Evaluation System |
30-Day Notice |
EZW |
— |
— |
| 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 |
— |
— |
| 2020-11-12 |
P080025-S214 |
InterStim Therapy System and Verify Evaluation System (SNS Bowel) |
30-Day Notice |
QON |
— |
— |
| 2020-11-12 |
P080025-S213 |
InterStim Therapy System, Verify Evaluation System |
30-Day Notice |
QON |
— |
— |
| 2020-11-04 |
P970004-S317 |
InterStim SureScan MRI Leads |
30-Day Notice |
EZW |
— |
— |
| 2020-11-04 |
P080025-S212 |
InterStim SureScan MRI Leads |
30-Day Notice |
QON |
— |
— |
| 2020-11-03 |
P970004-S315 |
InterStim Therapy System, Verify Evaluation System |
Real-Time Process |
EZW |
— |
— |
| 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 |
— |
— |
| 2020-11-03 |
P080025-S210 |
InterStim Therapy System, Verify Evaluation System |
Real-Time Process |
QON |
— |
— |
| 2020-10-01 |
P970004-S316 |
InterStim Therapy System and Verify Evaluation System (SNS Urinary) |
30-Day Notice |
EZW |
— |
— |
| 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 |
— |
— |
| 2020-10-01 |
P080025-S211 |
InterStim Therapy System and Verify Evaluation System (SNS Bowel) |
30-Day Notice |
QON |
— |
— |
| 2020-09-09 |
P970004-S314 |
InterStim Therapy System and Verify Evaluation System (SNS Urinary) |
30-Day Notice |
EZW |
— |
— |
| 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 |
— |
— |
| 2020-09-09 |
P080025-S209 |
InterStim Therapy System and Verify Evaluation System (SNS Bowel) |
30-Day Notice |
QON |
— |
— |
| 2020-09-06 |
P970004-S313 |
InterStim Therapy System and Verify Evaluation System (SNS Urinary) |
30-Day Notice |
EZW |
— |
— |
| 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 |
— |
— |
| 2020-09-06 |
P080025-S208 |
InterStim Therapy System and Verify Evaluation System (SNS Bowel) |
30-Day Notice |
QON |
— |
— |
| 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 |
— |
— |
| 2020-07-30 |
P970004-S302 |
InterStim Therapy System and Verify Evaluation System (SNS Urinary Programming Systems) |
Normal 180 Day Track |
EZW |
— |
— |
| 2020-07-30 |
P080025-S197 |
InterStim Therapy System and Verify Evaluation System (SNS Bowel Programming Systems) |
Normal 180 Day Track |
QON |
— |
— |
| 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 |
— |
— |
| 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 |
— |
— |
| 2020-06-09 |
P970004-S311 |
InterStim Therapy System and Verify Evaluation System (SNS Urinary) |
30-Day Notice |
EZW |
— |
— |
| 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 |
— |
— |
| 2020-06-09 |
P080025-S206 |
InterStim Therapy System and Verify Evaluation System (SNS Bowel) |
30-Day Notice |
QON |
— |
— |
| 2020-05-08 |
P970004-S310 |
InterStim Therapy System, Verify Evaluation System (SNS Urinary) |
30-Day Notice |
EZW |
— |
— |
| 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 |
— |
— |
| 2020-05-08 |
P080025-S205 |
InterStim Therapy System, Verify Evaluation System (SNS Bowel) |
30-Day Notice |
QON |
— |
— |
| 2020-05-07 |
P970004-S309 |
InterStim Therapy System and Verify Evaluation System (SNS Urinary) |
30-Day Notice |
EZW |
— |
— |
| 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 |
— |
— |
| 2020-05-07 |
P080025-S204 |
InterStim Therapy System and Verify Evaluation System (SNS Bowel) |
30-Day Notice |
QON |
— |
— |
| 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 |
— |
— |
| 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 |
— |
— |
| 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 |
— |
— |
| 2020-03-20 |
P970004-S308 |
InterStim Therapy System, Verify Evaluation System (SNS Urinary) |
30-Day Notice |
EZW |
— |
— |
| 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 |
— |
— |
| 2020-03-20 |
P080025-S203 |
InterStim Therapy System, Verify Evaluation System (SNS Bowel) |
30-Day Notice |
QON |
— |
— |
| 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 |
— |
— |
| 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 |
— |
— |
| 2020-02-19 |
P970004-S292 |
InterStim Therapy System and Verify Evaluation System (SNS Urinary) |
Normal 180 Day Track |
EZW |
— |
— |
| 2020-02-13 |
P080025-S187 |
InterStim Therapy System and Verify Evaluation System (SNS Bowel) |
Normal 180 Day Track |
QON |
— |
— |
| 2020-02-05 |
P970004-S307 |
InterStim Therapy System, Verify Evaluation System (SNS Urinary) |
30-Day Notice |
EZW |
— |
— |
| 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 |
— |
— |
| 2020-02-05 |
P080025-S202 |
InterStim Therapy System, Verify Evaluation System (SNS Bowel) |
30-Day Notice |
QON |
— |
— |
| 2020-01-09 |
P970004-S306 |
InterStim Therapy System, Verify Evaluation System (SNS Urinary) |
30-Day Notice |
EZW |
— |
— |
| 2020-01-09 |
P970004-S305 |
InterStim Therapy System and Verify Evaluation System (SNS Urinary) |
30-Day Notice |
EZW |
— |
— |
| 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 |
— |
— |
| 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 |
— |
— |
| 2020-01-09 |
P080025-S201 |
InterStim Therapy System, Verify Evaluation System (SNS Bowel) |
30-Day Notice |
QON |
— |
— |
| 2020-01-09 |
P080025-S200 |
InterStim Therapy System and Verify Evaluation System (SNS Bowel) |
30-Day Notice |
QON |
— |
— |