| 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 ( (P950037/S227) | Biotronik, Inc. | 2021-08-19 |
| 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 ( (P050023/S160) | Biotronik, Inc. | 2021-08-19 |
| Ilivia Neo 7 DR-T, Intica Neo 7 DR-T, Intica Neo 5 DR-T (P000009/S094) | Biotronik, Inc. | 2021-08-19 |
| CardioMessenger Smart 4G (P050023/S159) | Biotronik, Inc. | 2021-08-13 |
| 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 ( (P050023/S158) | Biotronik, Inc. | 2021-07-21 |
| Ilivia Neo 7 DR-T, Intica Neo 7 DR-T, Intica Neo 5 DR-T (P000009/S093) | Biotronik, Inc. | 2021-07-21 |
| 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, (P950037/S226) | Biotronik, Inc. | 2021-07-21 |
| 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- (P980023/S106) | Biotronik, Inc. | 2021-07-21 |
| 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 (P070008/S127) | Biotronik, Inc. | 2021-07-21 |
| Drug Eluting Permanent Right Ventricular (RV) or Right Atrial (RA) Pacemaker Electrodes (P950037/S224) | Biotronik, Inc. | 2021-06-22 |
| Pulse Generator, Permanent, Implantable (P950037/S223) | Biotronik, Inc. | 2021-06-02 |
| Pulse Generator, Pacemaker, Implantable, with Cardiac Resynchronization (CRT-P) (P070008/S124) | Biotronik, Inc. | 2021-06-02 |
| Implantable Cardioverter Defibrillator (Non-CRT), Defibrillator, implantable, dual-chamber and Defibrillator, automatic (P050023/S155) | Biotronik, Inc. | 2021-06-02 |
| Pulse Generator, Pacemaker, Implantable with Cardiac Resynchronization (CRT-P) (P070008/S125) | Biotronik, Inc. | 2021-06-02 |
| Defibrillator, Automatic Implantable Crdioveter, with Cardiac Resynchronization (CRT-D), Defibrillator, Implantable Dual (P050023/S156) | Biotronik, Inc. | 2021-06-02 |
| Pulse Generator, Permanent, Implantable (P950037/S222) | Biotronik, Inc. | 2021-06-02 |
| Defibrillator, Implantable Dual-Chamber (P000009/S091) | Biotronik, Inc. | 2021-06-02 |
| PSW 2100.U and NEO 2100.U (P980023/S105) | Biotronik, Inc. | 2021-04-30 |
| PSW 2100.U and NEO 2100.U (P050023/S154) | Biotronik, Inc. | 2021-04-30 |
| PSW 2100.U and NEO 2100.U (P000009/S090) | Biotronik, Inc. | 2021-04-30 |
| PSW 2100.U and NEO 2100.U (P950037/S220) | Biotronik, Inc. | 2021-04-30 |
| PSW 2100.U and NEO 2100.U (P070008/S122) | Biotronik, Inc. | 2021-04-30 |
| 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, (P950037/S221) | Biotronik, Inc. | 2021-04-14 |
| 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 (P070008/S123) | Biotronik, Inc. | 2021-04-14 |
| 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 (P950037/S219) | Biotronik, Inc. | 2021-04-01 |
| Phylax AV ICD System (P000009/S086) | Biotronik, Inc. | 2021-03-08 |
| Renamic Neo Programmer (P950037/S213) | Biotronik, Inc. | 2021-03-08 |
| Tupos LV/ATX & Kronos LV-T CRT-D & Corox OWT Steroid LV Pacing Lead (P050023/S148) | Biotronik, Inc. | 2021-03-08 |
| Stratos LV CRT-P and Stratos LV-T CRT-P, Corox OTW BP Lead and Corox OTW-S BP Lead (P070008/S116) | Biotronik, Inc. | 2021-03-08 |
| Phylax AV ICD System (P000009/S089) | Biotronik, Inc. | 2020-12-18 |
| Siello S 45 leads and Solia S 45 leads (P950037/S215) | Biotronik, Inc. | 2020-12-18 |
| STRATOS LV CRT-P AND STRATOS LV-T CRT-P, COROX OTW BP LEAD AND COROX OTW-S BP LEAD (P070008/S121) | Biotronik, Inc. | 2020-12-18 |
| 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 (P950037/S218) | Biotronik, Inc. | 2020-12-18 |
| 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- (P980023/S104) | Biotronik, Inc. | 2020-12-18 |
| Tupos LV/ATX & Kronos LV-T CRT-D and Corox OWT Steroid LV Pacing Lead (P050023/S151) | Biotronik, Inc. | 2020-12-18 |
| Edora 8 CRT-P, Evity 8 CRT-P, and Enitra 8 CRT-P and Corox OTW, Sentus (ProMRI) OTW Drug Eluting Permanent Left Ventricu (P070008/S118) | Biotronik, Inc. | 2020-12-18 |
| 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 ( (P050023/S153) | Biotronik, Inc. | 2020-12-18 |
| 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 (P980023/S103) | Biotronik, Inc. | 2020-12-01 |
| Ilivia Neo 7 DR-T, Intica Neo 7 DR-T, and Intica Neo 5 DR-T (P000009/S088) | Biotronik, Inc. | 2020-12-01 |
| Tupos LV/ATx and Kronos LV-T CRT-D System (P050023/S152) | Biotronik, Inc. | 2020-12-01 |
| Dromos DR/SR Rate Adaptive Pacing Systems (P950037/S217) | Biotronik, Inc. | 2020-12-01 |
| Etrinsa 8 HF-T, Epyra 8 HF-T, and Eluna 8 HF-T (P070008/S120) | Biotronik, Inc. | 2020-12-01 |
| 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 (P070008/S119) | Biotronik, Inc. | 2020-11-17 |
| 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 (P950037/S216) | Biotronik, Inc. | 2020-11-17 |
| Home Monitoring System Version 3.48 (P950037/S214) | Biotronik, Inc. | 2020-11-05 |
| Home Monitoring System Version 3.48 (P070008/S117) | Biotronik, Inc. | 2020-11-05 |
| Home Monitoring System Version 3.48 (P980023/S102) | Biotronik, Inc. | 2020-11-05 |
| Home Monitoring System Version 3.48 (P000009/S087) | Biotronik, Inc. | 2020-11-05 |
| Home Monitoring System Version 3.48 (P050023/S150) | Biotronik, Inc. | 2020-11-05 |
| Tupos LV/ATX & Kronos LV-T CRT-D & Corox OWT Steroid LV Pacing Lead (P050023/S149) | Biotronik, Inc. | 2020-09-17 |
| Implantable Cardioverter Defibrillator (Non-CRT), Defibrillator, Implantable, Dual-Chamber and Defibrillator, Automatic (P050023/S147) | Biotronik, Inc. | 2020-07-16 |
| PSW 1904.U (P050023/S145) | Biotronik, Inc. | 2020-05-29 |
| PSW 1904.U (P070008/S115) | Biotronik, Inc. | 2020-05-29 |
| PSW 1904.U (P950037/S211) | Biotronik, Inc. | 2020-05-29 |
| PSW 1904.U (P000009/S084) | Biotronik, Inc. | 2020-05-29 |
| PSW 1904.U (P980023/S100) | Biotronik, Inc. | 2020-05-29 |
| Drug-Eluting Permanent Defibrillator Electrodes (P980023/S099) | Biotronik, Inc. | 2020-05-22 |
| 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 (P050023/S144) | Biotronik, Inc. | 2020-05-22 |
| Quadripolar CRT-D Systems (P070008/S114) | Biotronik, Inc. | 2020-05-22 |
| Defibrillator, Automatic Implantable Cardioverter with Cardiac Resynchronization (CRT-D), Implantable Cardioverter Defib (P050023/S139) | Biotronik, Inc. | 2020-05-11 |
| Defibrillator, Implantable Dual-Chamber (P000009/S082) | Biotronik, Inc. | 2020-05-11 |
| Pulse Generator, Permanent, Implantable (P950037/S207) | Biotronik, Inc. | 2020-05-11 |
| Implantable Cardioverter Defibrillator (Non-CRT) (P980023/S096) | Biotronik, Inc. | 2020-05-11 |
| Pulse Generator, Pacemaker, Implantable with Cardiac Resynchronization (CRT-P) (P070008/S110) | Biotronik, Inc. | 2020-05-11 |
| Implantable Cardioverter Defibrillator (Non-CRT), Defibrillator, implantable, dual-chamber, and Defibrillator, automatic (P050023/S146) | Biotronik, Inc. | 2020-04-22 |
| Defibrillator, implantable, dual-chamber (P000009/S085) | Biotronik, Inc. | 2020-04-22 |
| Pulse Generator, Permanent, Implantable (P950037/S212) | Biotronik, Inc. | 2020-04-22 |
| Implantable Cardioverter Defibrillator (Non-CRT) (P980023/S101) | Biotronik, Inc. | 2020-04-22 |
| Drug Eluting Permanent Left Ventricular (LV) Pacemaker Electrodes (P070008/S113) | Biotronik, Inc. | 2020-03-16 |
| 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 (P050023/S143) | Biotronik, Inc. | 2020-03-10 |
| Pulse Generator, Permanent, Implantable (P950037/S206) | Biotronik, Inc. | 2020-03-10 |
| Pulse Generator, Pacemaker, Implantable with cardiac Resynchronization (CRT-D) (P070008/S109) | Biotronik, Inc. | 2020-03-10 |
| Implantable Cardioverter Defibrillator (Non-CRT); Defibrillator, Implantable, Dual-Chamber and Defibrillator, automatic (P050023/S137) | Biotronik, Inc. | 2020-03-10 |
| Drug Eluting Permanent Right Venticular/Right Atrial Pacemaker Electrodes, Stylets, Stylet, Catheter, Blind Plug, Perman (P950037/S209) | Biotronik, Inc. | 2020-01-29 |
| Stylet Catheter, Implantable Cardioverter Defibrillator, Implantable Dual-Chamber Defibrillator, Defibrillator Automatic (P050023/S141) | Biotronik, Inc. | 2020-01-29 |
| Drug Eluting Permanent Left Ventricular Pacemaker Electrode, Pulse Generator Pacemaker Implantable with Cardiac Resynchr (P070008/S111) | Biotronik, Inc. | 2020-01-29 |
| Permanent Defibrillator Electrodes, Accessories to Permanent Pacemaker Electrode, Stylet Catheter (P980023/S097) | Biotronik, Inc. | 2020-01-29 |
| Siello/Solia S Leads Tip (P950037/S208) | Biotronik, Inc. | 2019-12-20 |
| Implantav Cardioverter Defibrillator (Non-CRT), Defibrillator, Implantable, Dual-Chamber and Defibrillator, automatic im (P050023/S140) | Biotronik, Inc. | 2019-12-19 |
| CardioMessenger Smart 4G LTE (P050023/S138) | Biotronik, Inc. | 2019-12-17 |
| Pulse Generator, Permanent Implantable DR-T/SR-T (P950037/S202) | Biotronik, Inc. | 2019-11-26 |
| Pulse Generator, Permanent Implantable, Pulse-Gererator, Pacemaker External, Adapter and Drug Eluting Permanent Right Ve (P950037/S205) | Biotronik, Inc. | 2019-10-18 |
| Pulse Generator, Pacemaker Implantble with Cardiac Resynchronization (CRT-P) and Drug Eluting Permanent Left Ventricular (P070008/S108) | Biotronik, Inc. | 2019-10-18 |
| Permanent Defibrillator Electrodes, Accessories to Permanent Pacemaker Electrode and Styley Catheter (P980023/S095) | Biotronik, Inc. | 2019-10-18 |
| Implantable Cardioverter Defibrillator (Non-CRT), Defibrillator, Implantable, dual chamber, Defibrillator, automatic imp (P050023/S136) | Biotronik, Inc. | 2019-10-18 |
| Corox OTW BP (P070008/S107) | Biotronik, Inc. | 2019-10-04 |
| STRATOS LV CRT-P AND STRATOS LV-T CRT-P, COROX OTW BP LEAD AND COROX OTW-S BP LEAD (P070008/S106) | Biotronik, Inc. | 2019-10-04 |
| TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEAD (P050023/S134) | Biotronik, Inc. | 2019-10-04 |
| DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS (P950037/S204) | Biotronik, Inc. | 2019-10-04 |
| PHYLAX AV ICD SYSTEM (P000009/S081) | Biotronik, Inc. | 2019-10-04 |
| PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM (P980023/S094) | Biotronik, Inc. | 2019-10-04 |
| sentus QP LV Lead (P070008/S104) | Biotronik, Inc. | 2019-09-24 |
| EP Passion Initiative (P050023/S132) | Biotronik, Inc. | 2019-09-24 |
| CardioMessenger Smart 3G (P050023/S135) | Biotronik, Inc. | 2019-09-16 |
| Ilivia Neo 7 DR-T and Intica Neo 7 and 5 DR-T (P000009/S080) | Biotronik, Inc. | 2019-09-04 |
| Ilivia Neo 7 VR-T, Intica Neo 7 and 5 VR-T, Ilivia Neo 7 VR-T DX, and Intica Neo 7 and 5 VR-T DX (P980023/S093) | Biotronik, Inc. | 2019-09-04 |
| Ilivia Neo 7 HF -T, Intica Neo 7 and 5 HF -T, Ilivia Neo 7 HF -T QP, and Intica Neo 7 and 5 HF -T QP (P050023/S133) | Biotronik, Inc. | 2019-09-04 |
| Pulse Generator, Pacemaker, Implantable, with Cardiac Resynchronization (CRT-P) (P070008/S105) | Biotronik, Inc. | 2019-07-19 |
| Pulse Generator, Permanent, Inplantable (P950037/S203) | Biotronik, Inc. | 2019-07-19 |
| PSW 1901 U (P950037/S200) | Biotronik, Inc. | 2019-07-18 |