Chrysalis Intelligence · Sponsors · Biotronik, Inc.

Biotronik, Inc.

Lake Oswego, OR, US · 14 510(k) clearances · 415 PMAs · 25 recalls

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Total clearances
14
2020-04-23 → 2026-05-01
Last 12 months
1
Product codes
5
Most recent
2026-05-01
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
MXD Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) Class II Cardiovascular 5 2026-05-01
LIT Catheter, Angioplasty, Peripheral, Transluminal Class II Cardiovascular 4 2025-04-04
DQY — — — 3 2024-09-12
LOX — — — 1 2024-10-25
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Class II Cardiovascular 1 2021-09-02
Class III

PMA approvals (415)

Total PMA records
415
Originals + supplements
Distinct product codes
12
First decision
2020-01-23
Most recent
2026-08-07
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-08-07 P170030-S065 ORSIRO Sirolimus Eluting Coronary Stent System Normal 180 Day Track No User Fee NIQ Coronary Drug-Eluting Stent Unknown
2026-07-23 P170030-S064 Orsiro Mission larger diameter stents Ø 4.5 5.0 mm Real-Time Process NIQ Coronary Drug-Eluting Stent Unknown
2026-07-01 P980023-S148 Plexa ProMRI S 60, Plexa ProMRI S 65, Plexa ProMRI S 75, Plexa ProMRI SD 60/16, Plexa ProMRI SD 65/16, Plexa ProMRI SD 6 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2026-07-01 P950037-S295 Solia T 53, Solia T 60, Solia S 45, Solia S 53, Solia S 60, Solia CSP S 53, Solia CSP S 60 30-Day Notice DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2026-06-24 P980023-S147 Acticor Sky VR-T (481989); Rivacor Sky VR-T (481984); Rivacor Rise VR-T (482020); Rivacor Aura VR-T (482015); Acticor Sk 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2026-06-24 P050023-S212 Acticor 7 VR-T DX (429525); Acticor 7 VR-T DF4 ProMRI (429526); Rivacor 3 VR-T DF4 ProMRI (429574); Rivacor 5 VR-T DF4 P 30-Day Notice MRM Defibrillator, Implantable, Dual-Chamber Unknown
2026-06-24 P000009-S131 Acticor Sky DR-T (481987); Rivacor Sky DR-T (481982); Rivacor Rise DR-T (482018); Rivacor Aura DR-T (482014) 30-Day Notice MRM Defibrillator, Implantable, Dual-Chamber Unknown
2026-06-22 P160025-S025 Pulsar-18 T3 Peripheral Self-Expanding Nitinol Stent System 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2026-06-22 P140030-S024 Astron Peripheral Self-Expanding Nitinol Stent System 30-Day Notice NIO Stent, Iliac Unknown
2026-06-11 P170030-S058 Orsiro Mission Sirolimus Eluting Coronary Stent System Normal 180 Day Track NIQ Coronary Drug-Eluting Stent Unknown
2026-06-05 P170030-S052 Orsiro Mission Sirolimus Eluting Coronary Stent System 135 Review Track For 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2026-06-05 P160003-S024 PRO-Kinetic Energy Coronary Stent System 135 Review Track For 30-Day Notice MAF Stent, Coronary Unknown
2026-05-28 P950037-S293 Siello T 53, Siello T 60, Siello JT 45, Siello JT 53, Solia T 53, Solia T 60, Solia JT 45, Solia JT 53, Siello S 45, Sie 30-Day Notice DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2026-05-15 P950037-S292 Drug Eluting Permanent Right Ventricular (RV) or Right Atrial (RA) Pacemaker Electrodes 30-Day Notice DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2026-05-07 P980023-S145 Acticor Sky VR-T, Rivacor Sky VR-T, Rivacor Rise VR-T, Rivacor Aura VR-T, Acticor Sky VR-T DX, Rivacor Sky VR-T DX, Riva 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2026-05-07 P950037-S290 Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6 DR, Edora 8 SR-T, Evity 8 S 30-Day Notice DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2026-05-07 P070008-S178 Edora 8 HF-T QP, Edora 8 HF-T, Evity 8 HF-T QP, Evity 8 HF-T, Enitra 8 HF-T QP, Enitra 8 HF-T, Amvia Sky HF-T, Amvia Sky 30-Day Notice NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown
2026-05-07 P050023-S210 Acticor 7 VR-T, Rivacor 7 VR-T, Rivacor 5 VR-T, Rivacor 3 VR-T, Acticor 7 VR-T DX, Rivacor 7 VR-T DX, Rivacor 5 VR-T DX, 30-Day Notice MRM Defibrillator, Implantable, Dual-Chamber Unknown
2026-05-07 P000009-S129 Acticor Sky DR-T, Rivacor Sky DR-T, Rivacor Rise DR-T, Rivacor Aura DR-T 30-Day Notice MRM Defibrillator, Implantable, Dual-Chamber Unknown
2026-04-24 P950037-S285 Renamic Neo Real-Time Process DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2026-04-24 P070008-S175 Renamic Neo Real-Time Process NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown
2026-04-24 P050023-S207 Renamic Neo Real-Time Process MRM Defibrillator, Implantable, Dual-Chamber Unknown
2026-04-24 P000009-S127 Renamic Neo Real-Time Process MRM Defibrillator, Implantable, Dual-Chamber Unknown
2026-04-15 P170030-S062 ORSIRO Sirolimus Eluting Coronary Stent System 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2026-04-15 P170030-S047 Orsiro Mission Sirolimus Eluting Coronary Stent System 135 Review Track For 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2026-04-15 P160003-S022 PRO-Kinetic Energy Coronary Stent System 135 Review Track For 30-Day Notice MAF Stent, Coronary Unknown
2026-04-02 P950037-S288 Solia CSP S Leads Normal 180 Day Track No User Fee NVN — —
2026-04-01 P170030-S061 ORSIRO Sirolimus Eluting Coronary Stent System; Synsiro Pro Sirolimus Eluting Coronary Stent System 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2026-04-01 P160003-S026 PRO-Kinetic Energy Coronary Stent System 30-Day Notice MAF Stent, Coronary Unknown
2026-03-30 P950037-S282 Amvia-Solvia Pulse Generators Scan Duration Extension Real-Time Process DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2026-03-27 P950037-S287 Pulse Generator, Permanent Implantable Edora 8 DR-T Evity 8 DR-T Enitra 8 DR-T Enticos 8 DR-T Evity 6 DR-T Enitra 6 DR-T 30-Day Notice DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2026-03-10 P160025-S024 Astron Pulsar Pulsar-18, Pulsar-18 T3 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2026-03-10 P140030-S023 Astron 30-Day Notice NIO Stent, Iliac Unknown
2026-03-05 P980023-S144 Acticor Sky VR-T (481989); Rivacor Sky VR-T (481984); Rivacor Rise VR-T (482020); Rivacor Aura VR-T (482015); Acticor Sk 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2026-03-05 P950037-S286 Edora 8 DR-T (407145); Evity 8 DR-T (407146); Enitra 8 DR-T (407147); Enticos 8 DR-T (407148); Evity 6 DR-T (407149); En 30-Day Notice DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2026-03-05 P070008-S176 Edora 8 HF-T QP (407137); Edora 8 HF-T (407138); Evity 8 HF-T QP (407139); Evity 8 HF-T (407140); Enitra 8 HF-T QP (4071 30-Day Notice NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown
2026-03-05 P050023-S208 Acticor 7 VR-T (429526); Rivacor 7 VR-T (429536); Rivacor 5 VR-T (429565); Rivacor 3 VR-T (429574); Acticor 7 VR-T DX (4 30-Day Notice MRM Defibrillator, Implantable, Dual-Chamber Unknown
2026-02-22 P170030-S060 Orsiro Mission Sirolimus Eluting Coronary Stent System; Synsiro Pro Sirolimus Eluting Coronary Stent System 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2026-02-20 P170030-S059 Orsiro Mission Sirolimus Eluting Coronary Stent System, Synsiro Pro Sirolimus Eluting Coronary Stent System 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2026-02-12 P950037-S280 Solia CSP S 53; Solia CSP S 60 Normal 180 Day Track NVN — —
2026-02-11 P980023-S142 PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2026-02-11 P950037-S283 DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS 30-Day Notice DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2026-02-11 P050023-S205 TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEAD 30-Day Notice MRM Defibrillator, Implantable, Dual-Chamber Unknown
2026-02-11 P000009-S125 PHYLAX AV ICD SYSTEM 30-Day Notice MRM Defibrillator, Implantable, Dual-Chamber Unknown
2026-02-03 P980023-S143 PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2026-02-03 P950037-S284 DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS 30-Day Notice DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2026-02-03 P070008-S174 STRATOS LV CRT-P AND STRATOS LV-T CRT-P, COROX OTW BP LEAD AND COROX OTW-S BP LEAD 30-Day Notice NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown
2026-02-03 P050023-S206 TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEAD 30-Day Notice MRM Defibrillator, Implantable, Dual-Chamber Unknown
2026-02-03 P000009-S126 PHYLAX AV ICD SYSTEM 30-Day Notice MRM Defibrillator, Implantable, Dual-Chamber Unknown
2025-12-18 P980023-S136 Acticor Sky VR-T 481989, Rivacor Sky VR-T 481984, Rivacor Rise VR-T 482020, Rivacor Aura VR-T 482015, Acticor Sky VR-T D Normal 180 Day Track LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2025-12-18 P950037-S274 Solia S 53 377177; Solia S 60 377179 Normal 180 Day Track DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2025-12-18 P050023-S199 Acticor Sky HF-T 481986, Rivacor Sky HF-T 481991, Rivacor Rise HF-T 482017, Rivacor Aura HF-T 482013, Acticor Sky HF-T Q Normal 180 Day Track MRM Defibrillator, Implantable, Dual-Chamber Unknown
2025-12-18 P000009-S120 Acticor Sky DR-T 481987, Rivacor Sky DR-T 481982, Rivacor Rise DR-T 482018, Rivacor Aura DR-T 482014 Normal 180 Day Track MRM Defibrillator, Implantable, Dual-Chamber Unknown
2025-12-17 P160025-S023 Astron Pulsar; Pulsar-18; Pulsar-18 T3 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2025-12-17 P140030-S022 Astron 30-Day Notice NIO Stent, Iliac Unknown
2025-12-10 P950037-S281 Siello T 53; Siello T 60; Siello JT 45; Siello JT 53; Solia T 53; Solia T 60; Solia JT 45; Solia JT 53; Siello S 45; Sie 30-Day Notice DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2025-12-10 P070008-S173 Sentus ProMRI OTW QP S-75; Sentus ProMRI OTW QP S-85; Sentus ProMRI OTW QP S-95; Sentus ProMRI OTW QP L-75; Sentus ProMR 30-Day Notice NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown
2025-10-29 P980023-S141 Pamira S 60 428768 Pamira S 65 428769 Pamira S 75 428770 Pamira SD 60/16 428771 Pamira SD 65/16 428772 Pamira SD 65/18 4 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2025-10-24 P950037-S272 Edora 8 DR-T; Evity 8 DR-T; Enitra 8 DR-T; Enticos 8 DR-T; Evity 6 DR-T; Enitra 6 DR-T; Edora 8 DR; Enitra 6 DR; Edora 8 135 Review Track For 30-Day Notice DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2025-10-24 P070008-S167 Edora 8 HF-T QP; Edora 8 HF-T; Evity 8 HF-T QP; Evity 8 HF-T; Enitra 8 HF-T QP; Enitra 8 HF-T; Enticos 8 HF-T QP; Entico 135 Review Track For 30-Day Notice NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown
2025-10-24 P050023-S196 Acticor 7 VR-T; Rivacor 7 VR-T; Rivacor 5 VR-T; Rivacor 3 VR-T; Acticor 7 VR-T DX; Rivacor 7 VR-T DX; Rivacor 5 VR-T DX; 135 Review Track For 30-Day Notice MRM Defibrillator, Implantable, Dual-Chamber Unknown
2025-10-21 P160025-S022 Pulsar-18 T3 Stent System Special (Immediate Track) NIP Stent, Superficial Femoral Artery Unknown
2025-10-21 P140030-S021 Astron Peripheral Self- Expanding Nitinol Stent System Special (Immediate Track) NIO Stent, Iliac Unknown
2025-10-16 P980023-S139 Ilivia Neo 7 VR-T DX 429530; Intica Neo 7 VR-T DX 429559; Intica Neo 5 VR-T DX 429569 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2025-10-16 P950037-S278 Edora 8 DR-T 407145, Evity 8 DR-T 407146, Enitra 8 DR-T 407147, Enticos 8 DR-T 407148, Evity 6 DR-T 407149, Enitra 6 DR- 30-Day Notice DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2025-10-16 P070008-S171 Edora 8 HF-T QP 407137 Edora 8 HF-T 407138 Evity 8 HF-T QP 407139 Evity 8 HF-T 407140 Enitra 8 HF-T QP 407141 Enitra 8 H 30-Day Notice NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown
2025-10-16 P050023-S203 Ilivia 7 VR-T DX 404624; Intica 7 VR-T DX 404633; Intica 5 VR-T DX 404688; Ilivia 7 VR-T 404625; Intica 7 VR-T 404634; I 30-Day Notice MRM Defibrillator, Implantable, Dual-Chamber Unknown
2025-10-16 P000009-S123 Ilivia Neo 7 DR-T 429529; Intica Neo 7 DR-T 429558; Intica Neo 5 DR-T 429568 30-Day Notice MRM Defibrillator, Implantable, Dual-Chamber Unknown
2025-10-10 P170030-S056 Orsiro Mission Sirolimus Eluting Coronary Stent System 135 Review Track For 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2025-10-01 P980023-S138 Ilivia Neo 7 VR-T DX; Ilivia Neo 7 VR-T; Intica Neo 7 VR-T DX; Intica Neo 7 VR-T; Intica Neo 5 VR-T DX; Intica Neo 5 VR- Special (Immediate Track) LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2025-10-01 P950037-S277 Edora 8 DR-T; Evity 8 DR-T; Enitra 8 DR-T; Enticos 8 DR-T; Evity 6 DR-T; Enitra 6 DR-T; Edora 8 DR; Enitra 6 DR; Edora 8 Special (Immediate Track) NVZ Pulse Generator, Permanent, Implantable Unknown
2025-10-01 P050023-S202 Ilivia 7 VR-T DX; Intica 7 VR-T DX; Intica 5 VR-T DX; Ilivia 7 VR-T; Ilivia 7 DF4 VR-T; Intica 7 VR-T; Intica 7 DF4 VR-T Special (Immediate Track) LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2025-10-01 P000009-S122 Ilivia Neo 7 DR-T; Intica Neo 7 DR-T; Intica Neo 5 DR-T Special (Immediate Track) MRM Defibrillator, Implantable, Dual-Chamber Unknown
2025-09-15 P980023-S137 Ilivia Neo 7 VR-T DX; Ilivia Neo 7 VR-T; Intica Neo 7 VR-T DX; Intica Neo 7 VR-T; Intica Neo 5 VR-T DX; Intica Neo 5 VR- 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2025-09-15 P950037-S276 Edora 8 DR-T (407145); Evity 8 DR-T (407146); Enitra 8 DR-T (407147); Enticos 8 DR-T (407148); Evity 6 DR-T (407149); En 30-Day Notice DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2025-09-15 P070008-S170 Edora 8 HF-T QP 407137; Edora 8 HF-T 407138; Evity 8 HF-T QP 407139; Evity 8 HF-T 407140; Enitra 8 HF-T QP 407141; Enitr 30-Day Notice NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown
2025-09-15 P050023-S201 Ilivia 7 VR-T DX 404624; Intica 7 VR-T DX 404633; Intica 5 VR-T DX 404688; Ilivia 7 VR-T 404625; Ilivia 7 DF4 VR-T 40462 30-Day Notice MRM Defibrillator, Implantable, Dual-Chamber Unknown
2025-09-15 P000009-S121 Ilivia Neo 7 DR-T 429529; Intica Neo 7 DR-T 429558; Intica Neo 5 DR-T 429568 30-Day Notice MRM Defibrillator, Implantable, Dual-Chamber Unknown
2025-09-11 P950037-S275 Edora 8 DR-T (407145); Evity 8 DR-T (407146); Enitra 8 DR-T (407147); Enticos 8 DR-T (407148); Evity 6 DR-T (407149); En 30-Day Notice DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2025-09-11 P070008-S169 Edora 8 HF-T QP (407137); Edora 8 HF-T (407138); Evity 8 HF-T QP (407139); Evity 8 HF-T (407140); Enitra 8 HF-T QP (4071 30-Day Notice NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown
2025-09-11 P050023-S200 Acticor 7 VR-T (429526); Rivacor 7 VR-T (429536); Rivacor 5 VR-T (429565); Rivacor 3 VR-T (429574); Acticor 7 VR-T DX (4 30-Day Notice MRM Defibrillator, Implantable, Dual-Chamber Unknown
2025-08-22 P050023-S197 CardioMessenger Smart 4G Real-Time Process OSR Pacemaker/Icd/Crt Non-Implanted Components Unknown
2025-08-19 P170030-S055 Orsiro Mission Sirolimus Eluting Coronary Stent System; Synsiro Pro Sirolimus Eluting Coronary Stent System Real-Time Process NIQ Coronary Drug-Eluting Stent Unknown
2025-07-16 P140030-S019 Astron 30-Day Notice NIO Stent, Iliac Unknown
2025-07-10 P170030-S057 Orsiro Mission Sirolimus Eluting Coronary Stent System 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2025-07-10 P160025-S020 Astron Pulsar; Pulsar-18; Pulsar-18 T3 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2025-07-10 P160003-S025 PRO-Kinetic Energy Coronary Stent System 30-Day Notice MAF Stent, Coronary Unknown
2025-07-10 P140030-S018 Astron 30-Day Notice NIO Stent, Iliac Unknown
2025-06-18 P950037-S273 Edora 8 DR-T 407145, Evity 8 DR-T 407146, Enitra 8 DR-T 407147, Enticos 8 DR-T 407148, Evity 6 DR-T 407149, Enitra 6 DR- 30-Day Notice DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2025-06-18 P070008-S168 Edora 8 HF-T QP 407137, Edora 8 HF-T 407138, Evity 8 HF-T QP 407139, Evity 8 HF-T 407140, Enitra 8 HF-T QP 407141, Enitr 30-Day Notice NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown
2025-06-18 P050023-S198 Acticor 7 VR-T 429526, Rivacor 7 VR-T 429536, Rivacor 5 VR-T 429565, Rivacor 3 VR-T 429574, Acticor 7 VR-T DX 429525, Ri 30-Day Notice MRM Defibrillator, Implantable, Dual-Chamber Unknown
2025-06-12 P070008-S165 Sentus QP Pacing Leads Normal 180 Day Track No User Fee NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown
2025-06-12 P050023-S193 Sentus QP Pacing Leads Normal 180 Day Track No User Fee MRM Defibrillator, Implantable, Dual-Chamber Unknown
2025-05-15 P170030-S054 Orsiro Mission Sirolimus Eluting Coronary Stent System 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2025-04-15 P980023-S108 Home Monitoring System Version 3.52.0 Normal 180 Day Track LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2025-04-15 P950037-S229 Home Monitoring System Version 3.52.0 Normal 180 Day Track DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2025-04-15 P070008-S131 Home Monitoring System Version 3.52.0 Normal 180 Day Track NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown
2025-04-15 P050023-S162 Home Monitoring System Version 3.52.0 Normal 180 Day Track MRM Defibrillator, Implantable, Dual-Chamber Unknown
2025-04-15 P000009-S095 Home Monitoring System Version 3.52.0 Normal 180 Day Track MRM Defibrillator, Implantable, Dual-Chamber Unknown
2025-04-11 P170030-S051 Orsiro Mission Sirolimus Eluting Coronary Stent System Special (Immediate Track) NIQ Coronary Drug-Eluting Stent Unknown
2025-04-09 P170030-S053 ORSIRO Sirolimus Eluting Coronary Stent System 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2025-04-03 P950037-S269 Renamic Neo Real-Time Process DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2025-04-03 P070008-S164 Renamic Neo Real-Time Process NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown
2025-04-03 P050023-S192 Renamic Neo Real-Time Process MRM Defibrillator, Implantable, Dual-Chamber Unknown
2025-04-03 P000009-S118 Renamic Neo Real-Time Process MRM Defibrillator, Implantable, Dual-Chamber Unknown
2025-03-10 P980023-S133 Pamira S DX 65/15, Pamira S DX 65/17, Plexa ProMRI S DX 65/15, Plexa ProMRI S DX 65/17 Real-Time Process LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2025-03-10 P950037-S267 Safio S 53, Setrox S 53, Solia S 45, Solia S 53, Solia S 60, Siello S 45, Siello S 53, Siello S 60 Real-Time Process DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2025-03-10 P070008-S163 Corox (ProMRI) OTW 75 BP, Corox (ProMRI) OTW-S 75 BP, Corox (ProMRI) OTW-L 75 BP, Corox (ProMRI) OTW 85 BP, Corox (ProMR Real-Time Process NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown
2025-03-10 P050023-S190 Ilivia 7 HF-T, Intica 7/5 HF-T, Acticor 7 HF-T, Rivacor 7/5/3 HF-T, Ilivia 7 HF-T QP, Initca 7 HF-T QP, Acticor 7 HF-T Q Real-Time Process MRM Defibrillator, Implantable, Dual-Chamber Unknown
2025-03-05 P980023-S135 Ilivia Neo 7 VR-T DX, Ilivia Neo 7 VR-T, Intica Neo 7 VR-T DX, Intica Neo 7 VR-T, Intica Neo 5 VR-T DX, Intica Neo 5 VR- 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2025-03-05 P950037-S271 Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Enticos 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6 DR, Edora 8 30-Day Notice DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2025-03-05 P050023-S195 Ilivia 7 VR-T DX, Intica 7 VR-T DX, Intica 5 VR-T DX, Ilivia 7 VR-T, Ilivia 7 DF4 VR-T, Intica 7 VR-T, Intica 7 DF4 VR-T 30-Day Notice MRM Defibrillator, Implantable, Dual-Chamber Unknown
2025-03-05 P000009-S119 Ilivia Neo 7 DR-T, Intica Neo 7 DR-T, Intica Neo 5 DR-T 30-Day Notice MRM Defibrillator, Implantable, Dual-Chamber Unknown
2025-03-03 P170030-S048 Orsiro Mission Sirolimus Eluting Coronary Stent System Real-Time Process NIQ Coronary Drug-Eluting Stent Unknown
2025-03-03 P160025-S019 Pulsar-18 T3 Real-Time Process NIP Stent, Superficial Femoral Artery Unknown
2025-03-03 P140030-S017 Astron Real-Time Process NIO Stent, Iliac Unknown
2025-02-20 P950037-S270 Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Enticos 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6 DR, Edora 8 30-Day Notice DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2025-02-20 P070008-S166 Edora 8 HF-T QP, Edora 8 HF-T, Evity 8 HF-T QP, Evity 8 HF-T, Enitra 8 HF-T QP, Enitra 8 HF-T, Enticos 8 HF-T QP, Entico 30-Day Notice NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown
2025-02-20 P050023-S194 Acticor 7 VR-T, Rivacor 7 VR-T, Rivacor 5 VR-T, Rivacor 3 VR-T, Acticor 7 VR-T DX, Rivacor 7 VR-T DX, Rivacor 5 VR-T DX, 30-Day Notice MRM Defibrillator, Implantable, Dual-Chamber Unknown
2025-02-14 P170030-S050 ORSIRO Sirolimus Eluting Coronary Stent System, Orsiro Mission Sirolimus Eluting Coronary Stent System 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2025-02-14 P170030-S049 Orsiro Mission Sirolimus Eluting Coronary Stent System 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2025-02-14 P160003-S023 PRO-Kinetic Energy Coronary Stent System 30-Day Notice MAF Stent, Coronary Unknown
2025-02-05 P980023-S134 Ilivia Neo 7 VR-T DX, Ilivia Neo 7 VR-T, Intica Neo 7 VR-T DX, Intica Neo 7 VR-T, Intica Neo 5 VR-T DX, Intica Neo 5 VR 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2025-02-05 P950037-S268 Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Enticos 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6 DR, Edora 8 30-Day Notice DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2025-02-05 P050023-S191 Ilivia 7 VR-T DX, Intica 7 VR-T DX, Intica 5 VR-T DX, Ilivia 7 VR-T, Ilivia 7 DF4 VR-T, Intica 7 VR-T, Intica 7 DF4 VR-T 30-Day Notice MRM Defibrillator, Implantable, Dual-Chamber Unknown
2025-02-05 P000009-S117 Ilivia Neo 7 DR-T, Intica Neo 7 DR-T, Intica Neo 5 DR-T 30-Day Notice MRM Defibrillator, Implantable, Dual-Chamber Unknown
2024-12-11 P170030-S041 ORSIRO Sirolimus Eluting Coronary Stent System 135 Review Track For 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2024-12-11 P160025-S018 Pulsar-18 T3 Stent System Special (Immediate Track) NIP Stent, Superficial Femoral Artery Unknown
2024-12-06 P980023-S132 Ilivia Neo 7 VR-T DF-1 ProMRI, Ilivia Neo 7 VR-T DX DF-1 ProMRI, Intica Neo 5 VR-T DF-1 ProMRI, Intica Neo 5 VR-T DX DF- 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2024-12-06 P950037-S266 Amvia Edge DR-T, Amvia Edge SR-T, Amvia Sky DR-T, Amvia Sky SR-T, Solvia Rise DR-T, Solvia Rise SR-T, Amvia Edge HF-T QP 30-Day Notice DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2024-12-06 P070008-S162 Enitra 8 HF-T, Edora 8 HF-T QP, Edora 8 HF-T, Enitra 8 HF-T QP, Evity 8 HF-T, Evity 8 HF-T QP 30-Day Notice NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown
2024-12-06 P050023-S189 Acticor 7 DR-T DF4 ProMRI, Rivacor 3 DR-T DF4 ProMRI, Rivacor 5 DR-T DF4 ProMRI, Rivacor 7 DR-T DF4 ProMRI, Acticor 7 HF 30-Day Notice MRM Defibrillator, Implantable, Dual-Chamber Unknown
2024-12-06 P000009-S116 Intica Neo 5 DR-T DF-1 ProMRI, Ilivia Neo 7 DR-T DF-1 ProMRI, Intica Neo 7 DR-T DF-1 ProMRI 30-Day Notice MRM Defibrillator, Implantable, Dual-Chamber Unknown
2024-12-05 P950037-S262 NEO 2401.U/1 Real-Time Process DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2024-12-05 P070008-S159 NEO 2401.U/1 Real-Time Process NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown
2024-12-05 P050023-S187 NEO 2401.U/1 Real-Time Process MRM Defibrillator, Implantable, Dual-Chamber Unknown
2024-12-05 P000009-S114 NEO 2401.U/1 Real-Time Process MRM Defibrillator, Implantable, Dual-Chamber Unknown
2024-10-25 P980023-S131 Implantable Cardioverter Defibrillator (Non- Crt) 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2024-10-25 P950037-S264 Pulse Generator, Permanent, Implantable 30-Day Notice DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2024-10-25 P070008-S161 Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (CRT-P) 30-Day Notice NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown
2024-10-25 P070008-S160 Sentus ProMRI OTW QP S-75, Sentus ProMRI OTW QP S-85, Sentus ProMRI OTW QP S-95, Sentus ProMRI OTW QP L-75, Sentus ProMR 30-Day Notice NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown
2024-10-25 P050023-S188 Implantable Cardioverter Defibrillator (Non- Crt), Defibrillator, Implantable, Dual-Chamber, Defibrillator, Automatic Im 30-Day Notice MRM Defibrillator, Implantable, Dual-Chamber Unknown
2024-10-25 P000009-S115 Defibrillator, Implantable, Dual-Chamber 30-Day Notice MRM Defibrillator, Implantable, Dual-Chamber Unknown
2024-10-21 P950037-S265 Solia S 45, Solia S 53, Solia S 60, Solia JT 45, Solia JT 53, Solia T 53, Solia T 60 30-Day Notice DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2024-10-17 P170030-S044 Orsiro Mission Sirolimus Eluting Coronary Stent System Real-Time Process NIQ Coronary Drug-Eluting Stent Unknown
2024-10-15 P170030-S045 Orsiro Mission Sirolimus Eluting Coronary Stent System Normal 180 Day Track NIQ Coronary Drug-Eluting Stent Unknown
2024-10-11 P950037-S261 Solia S Leads Normal 180 Day Track No User Fee DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2024-10-09 P980023-S130 TW – Torque wrench 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2024-10-09 P950037-S263 PK-175/2,3m Patient Cable, PK-83, 2.5m 30-Day Notice DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2024-09-26 P170030-S046 Orsiro Mission Sirolimus Eluting Coronary Stent System 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2024-09-24 P170030-S042 Orsiro Mission Sirolimus Eluting Coronary Stent System, Orsiro Sirolimus Eluting Coronary Stent System Real-Time Process NIQ Coronary Drug-Eluting Stent Unknown
2024-09-21 P980023-S129 Plexa ProMRI S 60, Plexa ProMRI S 65, Plexa ProMRI S 75, Plexa ProMRI SD 60/16, Plexa ProMRI SD 65/16, Plexa ProMRI SD 6 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2024-09-03 P980023-S128 Ilivia Neo 7 VR-T DX, Ilivia Neo 7 VR-T, Intica Neo 7 VR-T, Intica Neo 5 VR-T DX, Intica Neo 5 VR-T Real-Time Process LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2024-09-03 P050023-S186 Ilivia 7 VR-T DX, Intica 7 VR-T DX, Intica 5 VR-T DX, Ilivia 7 VR-T, Ilivia 7 DF4 VR-T, Intica 7 VR-T, Intica 7 DF4 VR-T Real-Time Process MRM Defibrillator, Implantable, Dual-Chamber Unknown
2024-09-03 P000009-S113 Ilivia Neo 7 HF -T QP, Ilivia Neo 7 HF -T, Intica Neo 7 HF -T QP, Intica Neo 7 HF -T, Intica Neo 5 HF -T QP, Intica Neo Real-Time Process MRM Defibrillator, Implantable, Dual-Chamber Unknown
2024-08-30 P950037-S255 Pulse Generator, Pacemaker, Implantable, with Cardiac Resynchronization (CRT-P), Pulse Generator, Permanent, Implantable Normal 180 Day Track DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2024-08-15 P950037-S260 DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS 30-Day Notice DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2024-08-14 P170030-S043 ORSIRO Sirolimus Eluting Coronary Stent System 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2024-07-31 P950037-S259 Pulse Generator, Permanent Implantable Real-Time Process DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2024-07-24 P170030-S040 Orsiro Mission Sirolimus Eluting Coronary Stent System 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2024-06-21 P050023-S179 Acticor 7 VR-T, Rivacor 7 VR-T, Rivacor 5 VR-T, Rivacor 3 VR-T, Acticor 7 VR-T DX, Rivacor 7 VR-T DX, Rivacor 5 VR-T DX, 135 Review Track For 30-Day Notice MRM Defibrillator, Implantable, Dual-Chamber Unknown
2024-06-13 P950037-S257 PSW 2401.U, NEO 2401.U Real-Time Process DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2024-06-13 P070008-S157 PSW 2401.U, NEO 2401.U Real-Time Process NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown
2024-06-13 P050023-S183 PSW 2401.U, NEO 2401.U Real-Time Process MRM Defibrillator, Implantable, Dual-Chamber Unknown
2024-06-13 P000009-S110 PSW 2401.U, NEO 2401.U Real-Time Process MRM Defibrillator, Implantable, Dual-Chamber Unknown
2024-06-06 P170030-S039 ORSIRO Mission Sirolimus Eluting Coronary Stent System Special (Immediate Track) NIQ Coronary Drug-Eluting Stent Unknown
2024-05-29 P980023-S127 Implantable Cardioverter Defibrillator (Non-CRT) 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2024-05-29 P050023-S185 Implantable Cardioverter Defibrillator (Non-CRT), Defibrillator, automatic implantable cardioverter, with cardiac resync 30-Day Notice MRM Defibrillator, Implantable, Dual-Chamber Unknown
2024-05-29 P000009-S112 Defibrillator, implantable, dual-chamber 30-Day Notice MRM Defibrillator, Implantable, Dual-Chamber Unknown
2024-05-19 P980023-S126 Ilivia Neo 7 VR-T, Intica Neo 7 VR-T DX, Plexa ProMRI DF-1 S DX 65/17, Plexa ProMRI DF-1 S DX 65/15, Plexa ProMRI S 60, 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2024-05-19 P950037-S258 Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6 DR, Enticos 4 DR, Enticos 4 30-Day Notice DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2024-05-19 P070008-S158 Sentus ProMRI OTW QP S-75, Sentus ProMRI OTW QP S-85, Sentus ProMRI OTW QP S-95, Sentus ProMRI OTW QP L-75, Sentus ProMR 30-Day Notice NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown
2024-05-19 P050023-S184 Intica Neo 7 HF -T, Intica Neo 7 HF -T QP, BS IS4 30-Day Notice MRM Defibrillator, Implantable, Dual-Chamber Unknown
2024-05-19 P000009-S111 Ilivia Neo 7 DR-T 30-Day Notice MRM Defibrillator, Implantable, Dual-Chamber Unknown
2024-05-17 P170030-S038 Orsiro Sirolimus Eluting Coronary Stent System, Orsiro Mission Sirolimus Eluting Coronary Stent System Special (Immediate Track) NIQ Coronary Drug-Eluting Stent Unknown
2024-05-17 P160003-S021 PRO-Kinetic Energy Coronary Stent System Special (Immediate Track) MAF Stent, Coronary Unknown
2024-05-09 P980023-S124 Acticor 7 VR-T, Rivacor 7 VR-T, Rivacor 5 VR, -T, Rivacor 3 VR-T, Acticor 7 VR-T DX, Rivacor 7 VR-T DX, Rivacor 5 VR-T D Real-Time Process LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2024-05-09 P050023-S180 Acticor 7 HF-T, Rivacor 7 HF -T, Rivacor 5 HF -T, Rivacor 3 HF-T, Acticor 7 HF-T QP, Rivacor 7 HF –T QP, Rivacor 5 HF –T Real-Time Process MRM Defibrillator, Implantable, Dual-Chamber Unknown
2024-05-09 P000009-S107 Acticor 7 DR-T, Rivacor 7 DR-T, Rivacor 5 DR-T, Rivacor 3 DR-T Real-Time Process MRM Defibrillator, Implantable, Dual-Chamber Unknown
2024-05-08 P170030-S033 ORSIRO Sirolimus Eluting Coronary Stent System 135 Review Track For 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2024-05-02 P950037-S256 Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6 DR, Enticos 4 DR, Enticos 4 30-Day Notice DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2024-04-24 P170030-S037 Orsiro Mission Sirolimus Eluting Coronary Stent System 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2024-04-24 P160003-S020 PRO-Kinetic Energy Coronary Stent System 30-Day Notice MAF Stent, Coronary Unknown
2024-04-19 P980023-S125 Ilivia Neo 7 VR-T DX, Ilivia Neo 7 VR-T, Intica Neo 7 VR-T DX, Intica Neo 7 VR-T, Intica Neo 5 VR-T DX, Intica Neo 5 VR- 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2024-04-19 P050023-S182 Ilivia 7 VR-T DX, Intica 7 VR-T DX, Intica 5 VR-T DX, Ilivia 7 VR-T, Ilivia 7 VR-T, Intica 7 VR-T, Intica 7 DF4 VR-T, In 30-Day Notice MRM Defibrillator, Implantable, Dual-Chamber Unknown
2024-04-19 P000009-S109 Ilivia Neo 7 DR-T, Intica Neo 7 DR-T, Intica Neo 5 DR-T 30-Day Notice MRM Defibrillator, Implantable, Dual-Chamber Unknown
2024-03-26 P170030-S036 Orsiro Mission Sirolimus Eluting Coronary Stent System 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2024-03-26 P160003-S019 PRO-Kinetic Energy Coronary Stent System 30-Day Notice MAF Stent, Coronary Unknown
2023-12-21 P170030-S028 Orsiro Mission Sirolimus Eluting Coronary Stent System Normal 180 Day Track NIQ Coronary Drug-Eluting Stent Unknown
2023-12-13 P950037-S252 PSW 2303.U, NEO 2303.U Real-Time Process OSR Pacemaker/Icd/Crt Non-Implanted Components Unknown
2023-12-13 P070008-S151 PSW 2303.U, NEO 2303.U Real-Time Process NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown
2023-12-13 P050023-S177 PSW 2303.U, NEO 2303.U Real-Time Process MRM Defibrillator, Implantable, Dual-Chamber Unknown
2023-12-13 P000009-S105 PSW 2303.U, NEO 2303.U Real-Time Process MRM Defibrillator, Implantable, Dual-Chamber Unknown
2023-11-02 P980023-S123 Pamira S 60, Pamira S 65, Pamira S 75, Pamira SD 60/16, Pamira SD 65/16, Pamira SD 65/18, Pamira SD 75/18, Pamira S DX 6 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2023-11-02 P070008-S155 Sentus ProMRI OTW QP S-75, Sentus ProMRI OTW QP S-85, Sentus ProMRI OTW QP S-95, Sentus ProMRI OTW QP L-75, Sentus ProMR 30-Day Notice NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown
2023-10-27 P070008-S153 Edora 8 HF-T QP, Edora 8 HF-T, Evity 8 HF-T QP, Evity 8 HF-T, Enitra 8 HF-T QP, Enitra 8 HF-T, Enticos 8 HF-T QP, Entico 30-Day Notice NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown
2023-10-26 P170030-S034 Orsiro Mission Sirolimus Eluting Coronary Stent System Real-Time Process NIQ Coronary Drug-Eluting Stent Unknown
2023-10-24 P950037-S254 Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Enticos 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6 DR, Enticos 30-Day Notice DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2023-10-24 P070008-S154 Evity 8 F-T QP, Evity 8 HF-T, Enticos 8 HF-T QP, Enticos 8 HF-T, Enitra 8 HF-T QP, Enitra 8 HF-T, Edora 8 HF-T QP, Edora 30-Day Notice NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown
2023-10-23 P980023-S122 Implantable Cardioverter Defibrillator (Non-CRT) 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2023-10-23 P950037-S253 Pulse Generator, Permanent, Implantable 30-Day Notice DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2023-10-23 P070008-S152 Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (CRT-P) 30-Day Notice NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown
2023-10-23 P050023-S178 Implantable Cardioverter Defibrillator (Non-CRT), Defibrillator, implantable, dual-chamber, Defibrillator, automatic imp 30-Day Notice MRM Defibrillator, Implantable, Dual-Chamber Unknown
2023-10-23 P000009-S106 Defibrillator, implantable, dual-chamber 30-Day Notice MRM Defibrillator, Implantable, Dual-Chamber Unknown
2023-08-25 P170030-S032 ORSIRO Sirolimus Eluting Coronary Stent System, Orsiro Mission Sirolimus Eluting Coronary Stent System 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2023-08-24 P170030-S031 ORSIRO Sirolimus Eluting Coronary Stent System, Orsiro Mission Sirolimus Eluting Coronary Stent System 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2023-08-21 P950037-S250 PSW 2302.U, NEO 2302.U Real-Time Process DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2023-08-21 P070008-S150 PSW 2302.U, NEO 2302.U Real-Time Process NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown
2023-08-21 P050023-S176 PSW 2302.U, NEO 2302.U Real-Time Process MRM Defibrillator, Implantable, Dual-Chamber Unknown
2023-08-21 P000009-S104 PSW 2302.U, NEO 2302.U Real-Time Process MRM Defibrillator, Implantable, Dual-Chamber Unknown
2023-08-16 P950037-S251 Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Enticos 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6 DR, Enticos 30-Day Notice DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2023-08-16 P160003-S018 PRO-KINETIC ENERGY CORONARY STENT SYSTEM 30-Day Notice MAF Stent, Coronary Unknown
2023-08-07 P170030-S030 ORSIRO Sirolimus Eluting Coronary Stent System, Orsiro Mission Sirolimus Eluting Coronary Stent System 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2023-08-07 P160003-S017 PRO-Kinetic Energy Coronary Stent System 30-Day Notice MAF Stent, Coronary Unknown
2023-07-20 P160025-S017 Astron Pulsar, Pulsar-18, Pulsar-18 T3 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2023-07-20 P140030-S016 Astron 30-Day Notice NIO Stent, Iliac Unknown
2023-06-28 P980023-S121 Permanent Defibrillator Electrodes Real-Time Process LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2023-06-28 P950037-S249 Drug Eluting Permanent Right Ventricular (RV) or Right Atrial (RA) Pacemaker Electrodes Real-Time Process DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2023-06-28 P950037-S244 Pulse Generator, Pacemaker, Implantable with Cardiac Resynchronization (CRT-P) Normal 180 Day Track DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2023-06-28 P070008-S149 Drug Eluting Permanent Left Ventricular (LV) Pacemaker Electrode Real-Time Process NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown
2023-06-28 P070008-S144 Pacemaker/ICD/CRT non-implanted components Normal 180 Day Track NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown
2023-06-28 P050023-S175 Defibrillator, Implantable, Dual- Chamber, Defibrillator, Automatic Implantable Cardioverter, with Cardiac Resynchroniza Real-Time Process MRM Defibrillator, Implantable, Dual-Chamber Unknown
2023-06-28 P050023-S171 Pacemaker/ICD/CRT non-implanted components Normal 180 Day Track MRM Defibrillator, Implantable, Dual-Chamber Unknown
2023-06-28 P000009-S101 Pacemaker/ICD/CRT nonimplanted components Normal 180 Day Track MRM Defibrillator, Implantable, Dual-Chamber Unknown
2023-06-15 P170030-S029 Orsiro Sirolimus Eluting Coronary Stent System, Orsiro Mission Sirolimus Eluting Coronary Stent System 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2023-05-23 P160025-S016 Pulsar-18 T3 Stent System 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2023-05-11 P980023-S119 Home Monitoring System Version 3.56.0 Real-Time Process LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2023-05-11 P950037-S247 Home Monitoring System Version 3.56.0 Real-Time Process DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2023-05-11 P070008-S147 Home Monitoring System Version 3.56.0 Real-Time Process NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown
2023-05-11 P050023-S174 Home Monitoring System Version 3.56.0 Real-Time Process MRM Defibrillator, Implantable, Dual-Chamber Unknown
2023-05-11 P000009-S103 Home Monitoring System Version 3.56.0 Real-Time Process MRM Defibrillator, Implantable, Dual-Chamber Unknown
2023-04-13 P950037-S246 PSW 2301.U, NEO 2301.U Real-Time Process DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2023-04-13 P070008-S146 PSW 2301.U, NEO 2301.U Real-Time Process NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown
2023-04-13 P050023-S173 PSW 2301.U, NEO 2301.U Real-Time Process MRM Defibrillator, Implantable, Dual-Chamber Unknown
2023-04-13 P000009-S102 PSW 2301.U, NEO 2301.U Real-Time Process MRM Defibrillator, Implantable, Dual-Chamber Unknown
2023-04-04 P980023-S120 Plexa S 60, Plexa ProMRI S 60, Plexa ProMRI S 65, Plexa ProMRI S 75, Plexa SD 60/16, Plexa ProMRI SD 60/16, Plexa ProMRI 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2023-04-04 P950037-S248 Siello T 53, Siello T 60, Siello JT 45, Siello JT 53, Solia T 53, Solia T 60, Solia JT 45, Solia JT 53, Siello S 45, Sie 30-Day Notice DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2023-04-04 P070008-S148 Sentus ProMRI OTW QP S-75, Sentus ProMRI OTW QP S-85, Sentus ProMRI OTW QP S-95, Sentus ProMRI OTW QP L-75, Sentus ProMR 30-Day Notice NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown
2023-03-22 P170030-S023 Orsiro Mission Sirolimus Eluting Coronary Stent System, Orsiro Sirolimus Eluting Coronary Stent System Normal 180 Day Track NIQ Coronary Drug-Eluting Stent Unknown
2023-03-09 P950037-S245 Pulse Generator, Permanent, Implantable 30-Day Notice DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2023-03-09 P070008-S145 Pulse Generator, Pacemaker, Implantable, with Cardiac Resynchronization (CRT-P) 30-Day Notice NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown
2023-03-03 P170030-S027 Orsiro Sirolimus Eluting Coronary Stent System, Orsiro Mission Siroiimus Eiuting Coronary Stent System 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2023-03-03 P160003-S016 PRO-Kinetic Energy Coronary Stent System 30-Day Notice MAF Stent, Coronary Unknown
2023-02-13 P050023-S172 Implantable Cardioverter Defibrillator (Non-CRT), Defibrillator, implantable, dual-chamber, Defibrillator, automatic imp 30-Day Notice MRM Defibrillator, Implantable, Dual-Chamber Unknown
2023-01-26 P170030-S025 ORSIRO Mission Sirolimus Eluting Coronary Stent System 135 Review Track For 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2023-01-20 P980023-S113 Pamira ICD Leads Normal 180 Day Track NVY Permanent Defibrillator Electrodes Unknown
2023-01-16 P980023-S118 Protego EP PASSION Normal 180 Day Track No User Fee LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2023-01-16 P050023-S170 Protego EP PASSION Normal 180 Day Track No User Fee MRM Defibrillator, Implantable, Dual-Chamber Unknown
2023-01-12 P950037-S242 PSW 2202.U and NEO 2202.U Real-Time Process OSR Pacemaker/Icd/Crt Non-Implanted Components Unknown
2023-01-12 P070008-S143 Pacemaker/ICD/CRT Non-Implanted Components PSW 2202.U and NEO 2202.U Real-Time Process NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown
2023-01-12 P050023-S169 Pacemaker/ICD/CRT Non-Implanted Components PSW 2202.U and NEO 2202.U Real-Time Process MRM Defibrillator, Implantable, Dual-Chamber Unknown
2023-01-12 P000009-S100 Pacemaker/ICD/CRT Non-Implanted Components PSW 2202.U and NEO 2202.U Real-Time Process MRM Defibrillator, Implantable, Dual-Chamber Unknown
2022-12-16 P980023-S117 Drug-Eluting Permanent Defibrillator Electrodes 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2022-12-16 P950037-S243 Drug Eluting Permanent Right Ventricular (RV) or Right Atrial (RA) Pacemaker Electrodes 30-Day Notice DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2022-12-07 P980023-S116 Implantable Cardioverter Defibrillator (Non-CRT) 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2022-12-07 P950037-S241 Pulse Generator, Permanent, Implantable 30-Day Notice DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2022-12-07 P070008-S142 Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (CRT-P) 30-Day Notice NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown
2022-12-07 P050023-S168 Implantable Cardioverter Defibrillator (Non-CRT), Defibrillator, implantable, dual-chamber, Defibrillator, automatic imp 30-Day Notice MRM Defibrillator, Implantable, Dual-Chamber Unknown
2022-12-07 P000009-S099 Defibrillator, implantable, dual-chamber 30-Day Notice MRM Defibrillator, Implantable, Dual-Chamber Unknown
2022-12-02 P950037-S240 DataBridge 4G/LTE Adapter Real-Time Process DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2022-11-16 P070008-S141 Drug Eluting Permanent Left Ventricular (LV) Pacemaker Electrode 30-Day Notice NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown
2022-10-20 P980023-S115 Permanent Defibrillator Electrodes 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2022-10-20 P950037-S239 Drug Eluting Permanent Right Ventricular (RV), Right Atrial (RA) Pacemaker Electrodes 30-Day Notice DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2022-10-20 P070008-S140 Drug Eluting Permanent Left Ventricular (LV) Pacemaker Electrode 30-Day Notice NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown
2022-09-15 P950037-S238 Pulse Generator, Permanent, Implantable 30-Day Notice DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2022-09-15 P070008-S139 Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (CRT-P) 30-Day Notice NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown
2022-08-31 P170030-S022 Orsiro Sirolimus Eluting Coronary Stent System, Orsiro Mission Sirolimus Eluting Coronary Stent System Normal 180 Day Track No User Fee NIQ Coronary Drug-Eluting Stent Unknown
2022-08-22 P950037-S237 Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Enticos 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6 DR, Enticos 30-Day Notice DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2022-08-22 P070008-S138 Edora 8 HF-T QP, Edora 8 HF-T, Evity 8 HF-T QP, Evity 8 HF-T, Enitra 8 HF-T QP, Enitra 8 HF-T, Enticos 8 HF-T QP, Entico 30-Day Notice NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown
2022-08-05 P170030-S026 Orsiro Mission Sirolimus Eluting Coronary Stent System, Orsiro Sirolimus Eluting Coronary Stent System 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2022-07-27 P170030-S024 Orsiro Sirolimus Eluting Coronary Stent System, Orsiro Mission Sirolimus Eluting Coronary Stent System 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2022-07-27 P160025-S015 Astron Pulsar Stent System, Pulsar-18 Stent System 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2022-07-27 P160003-S015 PRO-Kinetic Energy Coronary Stent System 30-Day Notice MAF Stent, Coronary Unknown
2022-07-27 P140030-S015 Astron Peripheral Self-Expanding Nitinol Stent System 30-Day Notice NIO Stent, Iliac Unknown
2022-07-20 P160025-S013 Pulsar-18 T3 Stent System Normal 180 Day Track NIP Stent, Superficial Femoral Artery Unknown
2022-06-21 P980023-S114 Implantable Cardioverter Defibrillator (Non-CRT) 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2022-06-21 P950037-S236 Pulse Generator, Permanent, Implantable 30-Day Notice DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2022-06-21 P070008-S137 Pulse Generator, Pacemaker, Implantable, with Cardiac Resynchronization (CRT-DP) 30-Day Notice NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown
2022-06-21 P050023-S167 Implantable Cardioverter Defibrillator (Non-CRT), Defibrillator, implantable, dual-chamber, Defibrillator, automatic Def 30-Day Notice MRM Defibrillator, Implantable, Dual-Chamber Unknown
2022-06-21 P000009-S098 Defibrillator, Implantable, dual-chamber 30-Day Notice MRM Defibrillator, Implantable, Dual-Chamber Unknown
2022-05-20 P160025-S014 Pulsar-18 Stent Systems 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2022-04-11 P980023-S111 PSW 2201.U/1 and NEO 2201.U/1 Real-Time Process LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2022-04-11 P950037-S234 PSW 2201.U/1 and NEO 2201.U/1 Real-Time Process OSR Pacemaker/Icd/Crt Non-Implanted Components Unknown
2022-04-11 P070008-S136 PSW 2201.U/1 and NEO 2201.U/1 Real-Time Process NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown
2022-04-11 P050023-S166 PSW 2201.U/1 and NEO 2201.U/1 Real-Time Process MRM Defibrillator, Implantable, Dual-Chamber Unknown
2022-04-11 P000009-S097 PSW 2201.U/1 and NEO 2201.U/1 Real-Time Process MRM Defibrillator, Implantable, Dual-Chamber Unknown
2022-03-15 P980023-S112 Drug-Eluting Permanent Defibrillator Electrodes 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2022-03-15 P950037-S235 Drug Eluting Permanent Right Ventricular/Right Atrial Pacemaker Electrodes 30-Day Notice DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2022-03-08 P950037-S232 Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Enticos 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6 DR, Enticos Real-Time Process DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2022-03-08 P070008-S134 Edora 8 HF-T QP, Edora 8 HF-T, Evity 8 HF-T QP, Evity 8 HF-T, Enitra 8 HF-T QP, Enitra 8 HF-T, Enticos 8 HF-T QP, Entico Real-Time Process NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown
2022-03-08 P050023-S165 Acticor 7 VR-T, Rivacor 7 VR-T, Rivacor 5 VR-T, Rivacor 3 VR-T, Acticor 7 VR-T DX, Rivacor 7 VR-T DX, Rivacor 5 VR-T DX, Real-Time Process MRM Defibrillator, Implantable, Dual-Chamber Unknown
2022-03-04 P950037-S233 Siello S 45/Solia S 45, Siello S 53/Solia S 53, Siello S 60/Solia S 60 Normal 180 Day Track No User Fee DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2022-02-28 P070008-S135 Sentus ProMRI OTW QP S-75, Sentus ProMRI OTW QP S-85, Sentus ProMRI OTW QP S-95, Sentus ProMRI OTW QP L-75, Sentus ProMR 30-Day Notice NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown
2022-02-23 P170030-S021 ORSIRO Sirolimus Eluting Coronary Stent System and Orsiro Mission Sirolimus Eluting Coronary Stent System 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2022-02-18 P170030-S019 ORSIRO Sirolimus Eluting Coronary Stent System, ORSIRO Mission Sirolimus Eluting Coronary Stent System 135 Review Track For 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2022-01-27 P050023-S164 CardioMessenger Smart 4G Real-Time Process MRM Defibrillator, Implantable, Dual-Chamber Unknown
2021-12-22 P950037-S231 Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Enticos 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6 DR, Enticos 30-Day Notice DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2021-12-22 P070008-S133 Edora 8 HF-T QP, Edora 8 HF-T, Evity 8 HF-T QP, Evity 8 HF-T, Enitra 8 HF-T QP, Enitra 8 HF-T, Enticos 8 HF-T QP, Entico 30-Day Notice NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown
2021-12-20 P980023-S110 Drug-Eluting Permanent Defibrillator Electrodes 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2021-12-09 P950037-S225 NEO 2101.U Normal 180 Day Track DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2021-12-09 P170030-S020 ORSIRO Mission Sirolimus Eluting Coronary Stent System 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2021-12-09 P070008-S126 NEO 2101.U Normal 180 Day Track NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown
2021-12-09 P050023-S157 NEO 2101.U Normal 180 Day Track MRM Defibrillator, Implantable, Dual-Chamber Unknown
2021-12-09 P000009-S092 NEO 2101.U Normal 180 Day Track MRM Defibrillator, Implantable, Dual-Chamber Unknown
2021-10-29 P980023-S109 PHYLAX AV ICD SYSTEM 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2021-10-29 P950037-S230 Siello T/JT, Solia T/JT, Siello S, Solia S, Evia DR, Evia DR-T, Evia SR, Entovis DR, Entovis DR-T, Entovis SR, Entovis S 30-Day Notice DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2021-10-29 P070008-S132 Sentus ProMRI OTW QP S, Sentus ProMRI OTW QP S-xx/49, Sentus ProMRI OTW QP L, Sentus ProMRI OTW QP Lxx/49m, Evia HF, Evi 30-Day Notice NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown
2021-10-29 P050023-S163 Iforia 7, Ilesto 5, Iforia 5, Itrevia 7, Iperia 7, Ilivia 7, Intica 7, Intica 5, Inlexa 3, Inventra 7, Itrevia 5, Iperia 30-Day Notice MRM Defibrillator, Implantable, Dual-Chamber Unknown
2021-10-14 P160025-S012 Astron Pulsar Stent System 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2021-10-14 P140030-S014 Astron Peripheral Self-Expanding Nitinol Stent System 30-Day Notice NIO Stent, Iliac Unknown
2021-09-03 P070008-S129 Sentus QP leads 30-Day Notice NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown
2021-08-19 P980023-S107 Ilivia Neo 7 VR-T DX, Ilivia Neo 7 VR-T, Intica Neo 7 VR-T DX, Intica Neo 7 VR-T, Intica Neo 5 VR-T DX, Intica Neo 5 VR- 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2021-08-19 P950037-S227 Ilesto 7 VR-T DX, Ilesto 7 VR-T, Ilesto 5 VR-T DX, Ilesto 5 VR-T, Iforia 7 VR-T DX, Ilesto 7 VR-T (DF4), Ilesto 5 VR-T ( 30-Day Notice DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2021-08-19 P070008-S128 Etrinsa 8 HF-T, Epyra 8 HF-T, Eluna 8 HF-T 30-Day Notice NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown
2021-08-19 P050023-S160 Ilesto 7 VR-T DX, Ilesto 7 VR-T, Ilesto 5 VR-T DX, Ilesto 5 VR-T, Iforia 7 VR-T DX, Ilesto 7 VR-T (DF4), Ilesto 5 VR-T ( 30-Day Notice MRM Defibrillator, Implantable, Dual-Chamber Unknown
2021-08-19 P000009-S094 Ilivia Neo 7 DR-T, Intica Neo 7 DR-T, Intica Neo 5 DR-T 30-Day Notice MRM Defibrillator, Implantable, Dual-Chamber Unknown
2021-08-13 P050023-S159 CardioMessenger Smart 4G 30-Day Notice MRM Defibrillator, Implantable, Dual-Chamber Unknown
2021-07-28 P170030-S018 ORSIRO Sirolimus Eluting Coronary Stent System 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2021-07-21 P980023-S106 Ilivia Neo 7 VR-T DX, Ilivia Neo 7 VR-T, Intica Neo 7 VR-T DX, Intica Neo 7 VR-T, Intica Neo 5 VR-T DX, Intica Neo 5 VR- 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2021-07-21 P950037-S226 Evia SR-T, Evia SR, Evia DR-T, Evia DR, Entovis SR-T, Entovis DR-T, Entovis DR, Estella SR-T, Estella DR-T, Estella DR, 30-Day Notice DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2021-07-21 P070008-S127 Evia HF-T, Etrinsa 8 HF-T, Epyra 8 HF-T, Eluna 8 HF-T, Edora 8 HF-T QP, Edora 8 HF-T, Evity 8 HF-T QP, Evity 8 HF-T, Eni 30-Day Notice NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown
2021-07-21 P050023-S158 Ilesto 7 VR-T DX, Ilesto 7 VR-T, Ilesto 5 VR-T DX, Ilesto 5 VR-T, Iforia 7 VR-T DX, Ilesto 7 VR-T (DF4), Ilesto 5 VR-T ( 30-Day Notice MRM Defibrillator, Implantable, Dual-Chamber Unknown
2021-07-21 P000009-S093 Ilivia Neo 7 DR-T, Intica Neo 7 DR-T, Intica Neo 5 DR-T 30-Day Notice MRM Defibrillator, Implantable, Dual-Chamber Unknown
2021-07-13 P170030-S017 Orsiro Sirolimus Eluting Coronary Stent System 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2021-07-13 P160003-S014 PRO-Kinetic Energy Coronary Stent System 30-Day Notice MAF Stent, Coronary Unknown
2021-06-24 P170030-S007 Orsiro Mission Sirolimus Eluting Coronary Stent System Normal 180 Day Track NIQ Coronary Drug-Eluting Stent Unknown
2021-06-22 P950037-S224 Drug Eluting Permanent Right Ventricular (RV) or Right Atrial (RA) Pacemaker Electrodes 30-Day Notice DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2021-06-02 P950037-S223 Pulse Generator, Permanent, Implantable 30-Day Notice DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2021-06-02 P950037-S222 Pulse Generator, Permanent, Implantable 30-Day Notice DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2021-06-02 P070008-S125 Pulse Generator, Pacemaker, Implantable with Cardiac Resynchronization (CRT-P) 30-Day Notice NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown
2021-06-02 P070008-S124 Pulse Generator, Pacemaker, Implantable, with Cardiac Resynchronization (CRT-P) 30-Day Notice NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown
2021-06-02 P050023-S156 Defibrillator, Automatic Implantable Crdioveter, with Cardiac Resynchronization (CRT-D), Defibrillator, Implantable Dual 30-Day Notice MRM Defibrillator, Implantable, Dual-Chamber Unknown
2021-06-02 P050023-S155 Implantable Cardioverter Defibrillator (Non-CRT), Defibrillator, implantable, dual-chamber and Defibrillator, automatic 30-Day Notice MRM Defibrillator, Implantable, Dual-Chamber Unknown
2021-06-02 P000009-S091 Defibrillator, Implantable Dual-Chamber 30-Day Notice MRM Defibrillator, Implantable, Dual-Chamber Unknown
2021-05-06 P170030-S016 Orsiro Sirolimus Eluting Coronary Stent System 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2021-05-06 P160025-S011 Astron Pulsar Stent System 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2021-05-06 P160003-S013 PRO-Kinetic Energy Coronary Stent System 30-Day Notice MAF Stent, Coronary Unknown
2021-05-06 P140030-S013 Astron Peripheral Self- Expanding Nitinol Stent System 30-Day Notice NIO Stent, Iliac Unknown
2021-04-30 P980023-S105 PSW 2100.U and NEO 2100.U Real-Time Process LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2021-04-30 P950037-S220 PSW 2100.U and NEO 2100.U Real-Time Process DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2021-04-30 P070008-S122 PSW 2100.U and NEO 2100.U Real-Time Process NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown
2021-04-30 P050023-S154 PSW 2100.U and NEO 2100.U Real-Time Process MRM Defibrillator, Implantable, Dual-Chamber Unknown
2021-04-30 P000009-S090 PSW 2100.U and NEO 2100.U Real-Time Process MRM Defibrillator, Implantable, Dual-Chamber Unknown
2021-04-23 P170030-S015 Orsiro Sirolimus Eluting Coronary Stent System 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2021-04-23 P160025-S010 Astron Pulsar Stent System and Pulsar-18 Stent System 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2021-04-23 P160003-S012 PRO-Kinetic Energy Coronary Stent System 30-Day Notice MAF Stent, Coronary Unknown
2021-04-23 P140030-S012 Astron Peripheral Self-Expanding Nitinol Stent System 30-Day Notice NIO Stent, Iliac Unknown
2021-04-14 P950037-S221 Evia SR-T, Evia SR, Evia DR-T, Evia DR, Entovis SR-T, Entovis SR, Entovis DR-T, Entovis DR, Estella SR-T, Estella DR-T, 30-Day Notice DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2021-04-14 P070008-S123 Evia HF-T, Etrinsa 8 HF-T, Epyra 8 HF-T, Eluna 8 HF-T, Edora 8 HF-T QP, Edora 8 HF-T, Evity 8 HF-T QP, Evity 8 HF-T, Eni 30-Day Notice NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown
2021-04-01 P950037-S219 Enticos 4 DR, Enticos 4 D, Enticos 4 SR, Enticos 4 S, Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Enticos 8 DR-T, Evity 6 30-Day Notice DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2021-03-08 P950037-S213 Renamic Neo Programmer Normal 180 Day Track OSR Pacemaker/Icd/Crt Non-Implanted Components Unknown
2021-03-08 P070008-S116 Stratos LV CRT-P and Stratos LV-T CRT-P, Corox OTW BP Lead and Corox OTW-S BP Lead Normal 180 Day Track NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown
2021-03-08 P050023-S148 Tupos LV/ATX & Kronos LV-T CRT-D & Corox OWT Steroid LV Pacing Lead Normal 180 Day Track MRM Defibrillator, Implantable, Dual-Chamber Unknown
2021-03-08 P000009-S086 Phylax AV ICD System Normal 180 Day Track MRM Defibrillator, Implantable, Dual-Chamber Unknown
2021-02-17 P170030-S014 ORSIRO Sirolimus Eluting Coronary Stent System 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2020-12-18 P980023-S104 Ilivia Neo 7 VR-T DX, Ilivia Neo 7 VR-T, Intica Neo 7 VR-T DX, Intica Neo 7 VR-T, Intica Neo 5 VR-T DX, Intica Neo 5 VR- 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2020-12-18 P950037-S218 Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Enticos 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6 DR, Edora 8 30-Day Notice DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2020-12-18 P950037-S215 Siello S 45 leads and Solia S 45 leads Real-Time Process DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2020-12-18 P070008-S121 STRATOS LV CRT-P AND STRATOS LV-T CRT-P, COROX OTW BP LEAD AND COROX OTW-S BP LEAD 30-Day Notice NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown
2020-12-18 P070008-S118 Edora 8 CRT-P, Evity 8 CRT-P, and Enitra 8 CRT-P and Corox OTW, Sentus (ProMRI) OTW Drug Eluting Permanent Left Ventricu Real-Time Process NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown
2020-12-18 P050023-S153 Ilesto 7 VR-T DX, Ilesto 7 VR-T, Ilesto 5 VR-T DX, Ilesto 5 VR-T, Iforia 7 VR-T DX, Ilesto 7 VR-T (DF4), Ilesto 5 VR-T ( 30-Day Notice MRM Defibrillator, Implantable, Dual-Chamber Unknown
2020-12-18 P050023-S151 Tupos LV/ATX & Kronos LV-T CRT-D and Corox OWT Steroid LV Pacing Lead Real-Time Process MRM Defibrillator, Implantable, Dual-Chamber Unknown
2020-12-18 P000009-S089 Phylax AV ICD System 30-Day Notice MRM Defibrillator, Implantable, Dual-Chamber Unknown
2020-12-01 P980023-S103 Ilivia Neo 7 VR-T DX, Ilivia Neo 7 VR-T, Intica Neo 7 VR-T DX, Intica Neo 7 VR-T, Intica Neo 5 VR-T DX, and Intica Neo 5 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2020-12-01 P950037-S217 Dromos DR/SR Rate Adaptive Pacing Systems 30-Day Notice DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2020-12-01 P070008-S120 Etrinsa 8 HF-T, Epyra 8 HF-T, and Eluna 8 HF-T 30-Day Notice NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown
2020-12-01 P050023-S152 Tupos LV/ATx and Kronos LV-T CRT-D System 30-Day Notice MRM Defibrillator, Implantable, Dual-Chamber Unknown
2020-12-01 P000009-S088 Ilivia Neo 7 DR-T, Intica Neo 7 DR-T, and Intica Neo 5 DR-T 30-Day Notice MRM Defibrillator, Implantable, Dual-Chamber Unknown
2020-11-17 P950037-S216 Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Enticos 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6 DR, Edora 8 30-Day Notice DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2020-11-17 P070008-S119 Edora 8 HF-T QP, Edora 8 HF-T, Evity 8 HF-T QP, Evity 8 HF-T, Enitra 8 HF-T QP, Enitra 8 HF-T, Enticos 8 HF-T QP, and En 30-Day Notice NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown
2020-11-13 P170030-S013 Orsiro Sirolimus Eluting Coronary Stent System 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2020-11-13 P170030-S012 Orsiro Sirolimus Eluting Coronary Stent System 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2020-11-05 P980023-S102 Home Monitoring System Version 3.48 Real-Time Process LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2020-11-05 P950037-S214 Home Monitoring System Version 3.48 Real-Time Process DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2020-11-05 P070008-S117 Home Monitoring System Version 3.48 Real-Time Process NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown
2020-11-05 P050023-S150 Home Monitoring System Version 3.48 Real-Time Process MRM Defibrillator, Implantable, Dual-Chamber Unknown
2020-11-05 P000009-S087 Home Monitoring System Version 3.48 Real-Time Process MRM Defibrillator, Implantable, Dual-Chamber Unknown
2020-10-30 P170030-S011 ORSIRO Sirolimus Eluting Coronary Stent System Normal 180 Day Track No User Fee NIQ Coronary Drug-Eluting Stent Unknown
2020-10-21 P170030-S010 ORSIRO Sirolimus Eluting Coronary Stent System 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2020-09-17 P050023-S149 Tupos LV/ATX & Kronos LV-T CRT-D & Corox OWT Steroid LV Pacing Lead Normal 180 Day Track No User Fee MRM Defibrillator, Implantable, Dual-Chamber Unknown
2020-08-20 P170030-S008 Orsiro Sirolimus Eluting Coronary Stent System 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2020-08-20 P160003-S011 PRO-Kinetic Energy Coronary Stent System 30-Day Notice MAF Stent, Coronary Unknown
2020-08-06 P160003-S010 PRO-Kinetic Energy Stent System 30-Day Notice MAF Stent, Coronary Unknown
2020-07-16 P050023-S147 Implantable Cardioverter Defibrillator (Non-CRT), Defibrillator, Implantable, Dual-Chamber and Defibrillator, Automatic Real-Time Process MRM Defibrillator, Implantable, Dual-Chamber Unknown
2020-06-15 P170030-S006 Orsiro Sirolimus Eluting Coronary Stent System 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2020-05-29 P980023-S100 PSW 1904.U Real-Time Process LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2020-05-29 P950037-S211 PSW 1904.U Real-Time Process DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2020-05-29 P070008-S115 PSW 1904.U Real-Time Process NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown
2020-05-29 P050023-S145 PSW 1904.U Real-Time Process MRM Defibrillator, Implantable, Dual-Chamber Unknown
2020-05-29 P000009-S084 PSW 1904.U Real-Time Process MRM Defibrillator, Implantable, Dual-Chamber Unknown
2020-05-22 P980023-S099 Drug-Eluting Permanent Defibrillator Electrodes Real-Time Process LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2020-05-22 P070008-S114 Quadripolar CRT-D Systems Real-Time Process NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown
2020-05-22 P050023-S144 Single/Dual Chamber ICD Systems, Bipolar CRT-D Systems and Acticor and Rivacor 1.5 T and 3.0 T ICD and CRT-D Systems Real-Time Process MRM Defibrillator, Implantable, Dual-Chamber Unknown
2020-05-11 P980023-S096 Implantable Cardioverter Defibrillator (Non-CRT) 135 Review Track For 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2020-05-11 P950037-S207 Pulse Generator, Permanent, Implantable 135 Review Track For 30-Day Notice DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2020-05-11 P070008-S110 Pulse Generator, Pacemaker, Implantable with Cardiac Resynchronization (CRT-P) 135 Review Track For 30-Day Notice NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown
2020-05-11 P050023-S139 Defibrillator, Automatic Implantable Cardioverter with Cardiac Resynchronization (CRT-D), Implantable Cardioverter Defib 135 Review Track For 30-Day Notice MRM Defibrillator, Implantable, Dual-Chamber Unknown
2020-05-11 P000009-S082 Defibrillator, Implantable Dual-Chamber 135 Review Track For 30-Day Notice MRM Defibrillator, Implantable, Dual-Chamber Unknown
2020-04-22 P980023-S101 Implantable Cardioverter Defibrillator (Non-CRT) 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2020-04-22 P950037-S212 Pulse Generator, Permanent, Implantable 30-Day Notice DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2020-04-22 P050023-S146 Implantable Cardioverter Defibrillator (Non-CRT), Defibrillator, implantable, dual-chamber, and Defibrillator, automatic 30-Day Notice MRM Defibrillator, Implantable, Dual-Chamber Unknown
2020-04-22 P000009-S085 Defibrillator, implantable, dual-chamber 30-Day Notice MRM Defibrillator, Implantable, Dual-Chamber Unknown
2020-03-16 P070008-S113 Drug Eluting Permanent Left Ventricular (LV) Pacemaker Electrodes 30-Day Notice NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown
2020-03-10 P950037-S206 Pulse Generator, Permanent, Implantable 135 Review Track For 30-Day Notice DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2020-03-10 P070008-S109 Pulse Generator, Pacemaker, Implantable with cardiac Resynchronization (CRT-D) 135 Review Track For 30-Day Notice NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown
2020-03-10 P050023-S143 Acticor 7 VR-T, Rivacor 7 VR-T, Rivacor 5 VR-T, Rivacor 3 VR-T, Acticor 7 VR-T DX, Rivacor 7 VR-T DX, and Rivacor 5 VR-T 30-Day Notice MRM Defibrillator, Implantable, Dual-Chamber Unknown
2020-03-10 P050023-S137 Implantable Cardioverter Defibrillator (Non-CRT); Defibrillator, Implantable, Dual-Chamber and Defibrillator, automatic 135 Review Track For 30-Day Notice MRM Defibrillator, Implantable, Dual-Chamber Unknown
2020-01-29 P980023-S097 Permanent Defibrillator Electrodes, Accessories to Permanent Pacemaker Electrode, Stylet Catheter 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2020-01-29 P950037-S209 Drug Eluting Permanent Right Venticular/Right Atrial Pacemaker Electrodes, Stylets, Stylet, Catheter, Blind Plug, Perman 30-Day Notice DXY Implantable Pacemaker Pulse-Generator Cardiovascular
2020-01-29 P070008-S111 Drug Eluting Permanent Left Ventricular Pacemaker Electrode, Pulse Generator Pacemaker Implantable with Cardiac Resynchr 30-Day Notice NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown
2020-01-29 P050023-S141 Stylet Catheter, Implantable Cardioverter Defibrillator, Implantable Dual-Chamber Defibrillator, Defibrillator Automatic 30-Day Notice MRM Defibrillator, Implantable, Dual-Chamber Unknown
2020-01-23 P170030-S001 Orsiro Sirolimus Eluting Coronary Stent System 135 Review Track For 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2020-01-23 P160025-S007 Astron Pulsar Stent System 135 Review Track For 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2020-01-23 P160003-S007 PRO-Kinetic Energy Coronary Stent System 135 Review Track For 30-Day Notice MAF Stent, Coronary Unknown
2020-01-23 P140030-S009 Astron Peripheral Self-Expanding Nitinol Stent System 135 Review Track For 30-Day Notice NIO Stent, Iliac Unknown
Safety

Recalls (25)

Class I (serious)
0
Risk of injury / death
Total recalls
25
Currently ongoing
0
Most recent
2021-03-08
DateSeverityStatusRecall # ProductCodeReason
2021-03-08 Class II Terminated Z-1465-2021 BIOTRONIK INTICA NEO 7 HF-T DF-1 IS-1 ProMRI, REF 429553, UDI: 04035479156831 - Product Usage: intended to provide ventr… — There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
2021-03-08 Class II Terminated Z-1464-2021 BIOTRONIK ILIVIA NEO 7 DR-T DF-1 ProMRI, REF 429529, UDI: 04035479156749 - Product Usage: intended to provide ventricula… — There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
2021-03-08 Class II Terminated Z-1463-2021 BIOTRONIK INTICA NEO 7 VR-T DX DF-1 ProMRI, REF 429559, UDI: 04035479156855 - Product Usage: intended to provide ventric… — There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
2021-03-08 Class II Terminated Z-1462-2021 BIOTRONIK ILIVIA NEO 7 VR-T DF-1 ProMRI, REF 429531, UDI: 04035479156763 - Product Usage: intended to provide ventricula… — There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
2021-03-08 Class II Terminated Z-1461-2021 BIOTRONIK ILIVIA 7, DR-T DF-1 PROMRI, REF 404622, UDI: 04035479142094 - Product Usage: intended to provide ventricular t… — There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
2021-03-08 Class II Terminated Z-1460-2021 BIOTRONIK INVENTRA 7, VR-T DX DF-1, REF 399437, UDI: 04035479136321 - Product Usage: intended to provide ventricular ta… — There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
2021-03-08 Class II Terminated Z-1459-2021 BIOTRONIK INVENTRA 7, VR-T DX DF-1 ProMRI, REF 399436, UDI: 04035479136314 - Product Usage: intended to provide ventric… — There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
2021-03-08 Class II Terminated Z-1458-2021 BIOTRONIK ILIVIA 7, VR-T DF4 ProMRI, REF 404626, UDI: 04035479142131 - Product Usage: intended to provide ventricular t… — There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
2021-03-08 Class II Terminated Z-1457-2021 BIOTRONIK ILIVIA 7, VR-T DF-1 ProMRI, REF 404625, UDI: 04035479142124 - Product Usage: intended to provide ventricular … — There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
2021-03-08 Class II Terminated Z-1456-2021 BIOTRONIK ILIVIA 7, DR-T DF4 ProMRI, REF 404623, UDI: 04035479142100 - Product Usage: intended to provide ventricular t… — There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
2021-03-08 Class II Terminated Z-1455-2021 BIOTRONIK ITREVIA 7, DR-T QP DF-1, REF 392412, UDI: 04035479128807 - Product Usage: intended to provide ventricular tac… — There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
2021-03-08 Class II Terminated Z-1454-2021 BIOTRONIK INVENTRA 7, HF-T QP DF4 IS4, REF 393012, UDI: 04035479129286 - Product Usage: intended to provide ventricular… — There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
2021-03-08 Class II Terminated Z-1453-2021 BIOTRONIK IPERIA 7, DR-T DF4 ProMRI, REF 392423, UDI: 04035479128913 - Product Usage: intended to provide ventricular ta… — There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
2021-03-08 Class II Terminated Z-1452-2021 BIOTRONIK ITREVIA 7, VR-T DF-4, REF 393041, UDI: 04035479129569 - Product Usage: intended to provide ventricular tachyca… — There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
2021-03-08 Class II Terminated Z-1451-2021 BIOTRONIK ITREVIA 7, VR-T DF-1, REF 393040, UDI: 04035479129552 - Product Usage: intended to provide ventricular tachyca… — There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
2021-03-08 Class II Terminated Z-1450-2021 BIOTRONIK ITREVIA 7, VR-T DX DF-1, REF 393037, UDI: 04035479129521 - Product Usage: intended to provide ventricular tach… — There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
2021-03-08 Class II Terminated Z-1449-2021 BIOTRONIK IPERIA 7,VR-T, DX, DF-1, ProMRI, REF 393032, UDI: 04035479129477 - Product Usage: intended to provide ventricu… — There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
2021-03-08 Class II Terminated Z-1448-2021 BIOTRONIK Iforia 7,DR-T, DF-1,REF 390064, UDI: 04035479126926 - Product Usage: intended to provide ventricular tachycard… — There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
2021-03-08 Class II Terminated Z-1447-2021 BIOTRONIK Iforia 7, vr-T, DX, DF-1,REF 390090, UDI: 04035479127176 - Product Usage: intended to provide ventricular tach… — There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
2021-03-08 Class II Terminated Z-1446-2021 BIOTRONIK Iperia 7, DR-T, DF-1, ProMRI REF 392409, UDI: 04035479128777 - Product Usage: intended to provide ventricular … — There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
2021-03-08 Class II Terminated Z-1445-2021 BIOTRONIK Ilestro 7 VR-T DX, DF-1, REF 383594, UDI: 04035479125509 - Product Usage: intended to provide ventricular tach… — There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
2021-03-08 Class II Terminated Z-1444-2021 BIOTRONIK Ilestro 7 VR-T, DF-4, REF 383580, UDI: 04035479125363 - Product Usage: intended to provide ventricular tachyca… — There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
2021-03-08 Class II Terminated Z-1443-2021 BIOTRONIK Ilestro 7 VR-T, DF-1, REF 383578, UDI: 04035479125349 - Product Usage: intended to provide ventricular tachyca… — There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
2021-03-08 Class II Terminated Z-1442-2021 BIOTRONIK Ilestro 7 DR-T, DF-4, REF383564, UDI: 04035479125202 - Product Usage: intended to provide ventricular tachycar… — There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
2021-03-08 Class II Terminated Z-1441-2021 BIOTRONIK Ilestro 7 DR-T, DF-1, REF383562, UDI: 04035479125189 - Product Usage: intended to provide ventricular tachycar… — There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
Filings

All 510(k) clearances (14)

Date K-number Device Code Class Specialty
2026-05-01 K261074 BIOMONITOR IV (471155) MXD Class II Cardiovascular
2025-04-04 K250706 Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter LIT Class II Cardiovascular
2024-10-25 K242969 Pantera Pro; Pantera LEO LOX — —
2024-09-12 K240787 Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518) DQY — —
2024-07-11 K241711 Oscar Peripheral Multifunctional Catheter system LIT Class II Cardiovascular
2023-05-19 K230375 BIOMONITOR IV MXD Class II Cardiovascular
2023-02-16 K222065 Passeo-35 Xeo Peripheral Dilatation Catheter LIT Class II Cardiovascular
2022-07-27 K221856 BIOMONITOR IIIm, BIOMONITOR III MXD Class II Cardiovascular
2022-07-19 K222037 Selectra Lead Implantation System DQY — —
2022-07-06 K214038 Oscar Peripheral Multifunctional Catheter system LIT Class II Cardiovascular
2021-09-02 K201445 MultiCath, AcQRate Dx Fixed Curve Catheter DRF Class II Cardiovascular
2020-12-08 K201865 Biomonitor III, Biomonitor IIIm MXD Class II Cardiovascular
2020-10-16 K193474 Selectra 3D Outer Guiding Catheters DQY — —
2020-04-23 K200444 Biomonitor III, Biomonitor IIIm MXD Class II Cardiovascular
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence