| Ilivia Neo 7 DR-T, Intica Neo 7 DR-T, Intica Neo 5 DR-T (P000009/S109) | Biotronik, Inc. | 2024-04-19 |
| 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/S125) | Biotronik, Inc. | 2024-04-19 |
| 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 (P050023/S182) | Biotronik, Inc. | 2024-04-19 |
| PSW 2303.U, NEO 2303.U (P000009/S105) | Biotronik, Inc. | 2023-12-13 |
| PSW 2303.U, NEO 2303.U (P070008/S151) | Biotronik, Inc. | 2023-12-13 |
| PSW 2303.U, NEO 2303.U (P050023/S177) | Biotronik, Inc. | 2023-12-13 |
| PSW 2303.U, NEO 2303.U (P950037/S252) | Biotronik, Inc. | 2023-12-13 |
| 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 (P070008/S155) | Biotronik, Inc. | 2023-11-02 |
| 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 (P980023/S123) | Biotronik, Inc. | 2023-11-02 |
| 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 (P070008/S153) | Biotronik, Inc. | 2023-10-27 |
| 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 (P070008/S154) | Biotronik, Inc. | 2023-10-24 |
| 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 (P950037/S254) | Biotronik, Inc. | 2023-10-24 |
| Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (CRT-P) (P070008/S152) | Biotronik, Inc. | 2023-10-23 |
| Pulse Generator, Permanent, Implantable (P950037/S253) | Biotronik, Inc. | 2023-10-23 |
| Implantable Cardioverter Defibrillator (Non-CRT), Defibrillator, implantable, dual-chamber, Defibrillator, automatic imp (P050023/S178) | Biotronik, Inc. | 2023-10-23 |
| Implantable Cardioverter Defibrillator (Non-CRT) (P980023/S122) | Biotronik, Inc. | 2023-10-23 |
| Defibrillator, implantable, dual-chamber (P000009/S106) | Biotronik, Inc. | 2023-10-23 |
| PSW 2302.U, NEO 2302.U (P950037/S250) | Biotronik, Inc. | 2023-08-21 |
| PSW 2302.U, NEO 2302.U (P050023/S176) | Biotronik, Inc. | 2023-08-21 |
| PSW 2302.U, NEO 2302.U (P070008/S150) | Biotronik, Inc. | 2023-08-21 |
| PSW 2302.U, NEO 2302.U (P000009/S104) | Biotronik, Inc. | 2023-08-21 |
| 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 (P950037/S251) | Biotronik, Inc. | 2023-08-16 |
| Pacemaker/ICD/CRT non-implanted components (P050023/S171) | Biotronik, Inc. | 2023-06-28 |
| Pacemaker/ICD/CRT nonimplanted components (P000009/S101) | Biotronik, Inc. | 2023-06-28 |
| Permanent Defibrillator Electrodes (P980023/S121) | Biotronik, Inc. | 2023-06-28 |
| Drug Eluting Permanent Right Ventricular (RV) or Right Atrial (RA) Pacemaker Electrodes (P950037/S249) | Biotronik, Inc. | 2023-06-28 |
| Defibrillator, Implantable, Dual- Chamber, Defibrillator, Automatic Implantable Cardioverter, with Cardiac Resynchroniza (P050023/S175) | Biotronik, Inc. | 2023-06-28 |
| Pulse Generator, Pacemaker, Implantable with Cardiac Resynchronization (CRT-P) (P950037/S244) | Biotronik, Inc. | 2023-06-28 |
| Drug Eluting Permanent Left Ventricular (LV) Pacemaker Electrode (P070008/S149) | Biotronik, Inc. | 2023-06-28 |
| Pacemaker/ICD/CRT non-implanted components (P070008/S144) | Biotronik, Inc. | 2023-06-28 |
| Home Monitoring System Version 3.56.0 (P000009/S103) | Biotronik, Inc. | 2023-05-11 |
| Home Monitoring System Version 3.56.0 (P980023/S119) | Biotronik, Inc. | 2023-05-11 |
| Home Monitoring System Version 3.56.0 (P950037/S247) | Biotronik, Inc. | 2023-05-11 |
| Home Monitoring System Version 3.56.0 (P070008/S147) | Biotronik, Inc. | 2023-05-11 |
| Home Monitoring System Version 3.56.0 (P050023/S174) | Biotronik, Inc. | 2023-05-11 |
| PSW 2301.U, NEO 2301.U (P000009/S102) | Biotronik, Inc. | 2023-04-13 |
| PSW 2301.U, NEO 2301.U (P070008/S146) | Biotronik, Inc. | 2023-04-13 |
| PSW 2301.U, NEO 2301.U (P950037/S246) | Biotronik, Inc. | 2023-04-13 |
| PSW 2301.U, NEO 2301.U (P050023/S173) | Biotronik, Inc. | 2023-04-13 |
| 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 (P070008/S148) | Biotronik, Inc. | 2023-04-04 |
| 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 (P950037/S248) | Biotronik, Inc. | 2023-04-04 |
| 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 (P980023/S120) | Biotronik, Inc. | 2023-04-04 |
| Pulse Generator, Pacemaker, Implantable, with Cardiac Resynchronization (CRT-P) (P070008/S145) | Biotronik, Inc. | 2023-03-09 |
| Pulse Generator, Permanent, Implantable (P950037/S245) | Biotronik, Inc. | 2023-03-09 |
| Implantable Cardioverter Defibrillator (Non-CRT), Defibrillator, implantable, dual-chamber, Defibrillator, automatic imp (P050023/S172) | Biotronik, Inc. | 2023-02-13 |
| Pamira ICD Leads (P980023/S113) | Biotronik, Inc. | 2023-01-20 |
| Protego EP PASSION (P980023/S118) | Biotronik, Inc. | 2023-01-16 |
| Protego EP PASSION (P050023/S170) | Biotronik, Inc. | 2023-01-16 |
| Pacemaker/ICD/CRT Non-Implanted Components PSW 2202.U and NEO 2202.U (P050023/S169) | Biotronik, Inc. | 2023-01-12 |
| Pacemaker/ICD/CRT Non-Implanted Components PSW 2202.U and NEO 2202.U (P000009/S100) | Biotronik, Inc. | 2023-01-12 |
| Pacemaker/ICD/CRT Non-Implanted Components PSW 2202.U and NEO 2202.U (P070008/S143) | Biotronik, Inc. | 2023-01-12 |
| PSW 2202.U and NEO 2202.U (P950037/S242) | Biotronik, Inc. | 2023-01-12 |
| Drug-Eluting Permanent Defibrillator Electrodes (P980023/S117) | Biotronik, Inc. | 2022-12-16 |
| Drug Eluting Permanent Right Ventricular (RV) or Right Atrial (RA) Pacemaker Electrodes (P950037/S243) | Biotronik, Inc. | 2022-12-16 |
| Pulse Generator, Permanent, Implantable (P950037/S241) | Biotronik, Inc. | 2022-12-07 |
| Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (CRT-P) (P070008/S142) | Biotronik, Inc. | 2022-12-07 |
| Implantable Cardioverter Defibrillator (Non-CRT), Defibrillator, implantable, dual-chamber, Defibrillator, automatic imp (P050023/S168) | Biotronik, Inc. | 2022-12-07 |
| Implantable Cardioverter Defibrillator (Non-CRT) (P980023/S116) | Biotronik, Inc. | 2022-12-07 |
| Defibrillator, implantable, dual-chamber (P000009/S099) | Biotronik, Inc. | 2022-12-07 |
| DataBridge 4G/LTE Adapter (P950037/S240) | Biotronik, Inc. | 2022-12-02 |
| Drug Eluting Permanent Left Ventricular (LV) Pacemaker Electrode (P070008/S141) | Biotronik, Inc. | 2022-11-16 |
| Drug Eluting Permanent Left Ventricular (LV) Pacemaker Electrode (P070008/S140) | Biotronik, Inc. | 2022-10-20 |
| Permanent Defibrillator Electrodes (P980023/S115) | Biotronik, Inc. | 2022-10-20 |
| Drug Eluting Permanent Right Ventricular (RV), Right Atrial (RA) Pacemaker Electrodes (P950037/S239) | Biotronik, Inc. | 2022-10-20 |
| Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (CRT-P) (P070008/S139) | Biotronik, Inc. | 2022-09-15 |
| Pulse Generator, Permanent, Implantable (P950037/S238) | Biotronik, Inc. | 2022-09-15 |
| 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 (P070008/S138) | Biotronik, Inc. | 2022-08-22 |
| 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 (P950037/S237) | Biotronik, Inc. | 2022-08-22 |
| Pulse Generator, Permanent, Implantable (P950037/S236) | Biotronik, Inc. | 2022-06-21 |
| Pulse Generator, Pacemaker, Implantable, with Cardiac Resynchronization (CRT-DP) (P070008/S137) | Biotronik, Inc. | 2022-06-21 |
| Implantable Cardioverter Defibrillator (Non-CRT) (P980023/S114) | Biotronik, Inc. | 2022-06-21 |
| Implantable Cardioverter Defibrillator (Non-CRT), Defibrillator, implantable, dual-chamber, Defibrillator, automatic Def (P050023/S167) | Biotronik, Inc. | 2022-06-21 |
| Defibrillator, Implantable, dual-chamber (P000009/S098) | Biotronik, Inc. | 2022-06-21 |
| PSW 2201.U/1 and NEO 2201.U/1 (P000009/S097) | Biotronik, Inc. | 2022-04-11 |
| PSW 2201.U/1 and NEO 2201.U/1 (P070008/S136) | Biotronik, Inc. | 2022-04-11 |
| PSW 2201.U/1 and NEO 2201.U/1 (P980023/S111) | Biotronik, Inc. | 2022-04-11 |
| PSW 2201.U/1 and NEO 2201.U/1 (P050023/S166) | Biotronik, Inc. | 2022-04-11 |
| PSW 2201.U/1 and NEO 2201.U/1 (P950037/S234) | Biotronik, Inc. | 2022-04-11 |
| Drug-Eluting Permanent Defibrillator Electrodes (P980023/S112) | Biotronik, Inc. | 2022-03-15 |
| Drug Eluting Permanent Right Ventricular/Right Atrial Pacemaker Electrodes (P950037/S235) | Biotronik, Inc. | 2022-03-15 |
| 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 (P070008/S134) | Biotronik, Inc. | 2022-03-08 |
| 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 (P950037/S232) | Biotronik, Inc. | 2022-03-08 |
| 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, (P050023/S165) | Biotronik, Inc. | 2022-03-08 |
| Siello S 45/Solia S 45, Siello S 53/Solia S 53, Siello S 60/Solia S 60 (P950037/S233) | Biotronik, Inc. | 2022-03-04 |
| 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 (P070008/S135) | Biotronik, Inc. | 2022-02-28 |
| CardioMessenger Smart 4G (P050023/S164) | Biotronik, Inc. | 2022-01-27 |
| 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 (P950037/S231) | Biotronik, Inc. | 2021-12-22 |
| 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 (P070008/S133) | Biotronik, Inc. | 2021-12-22 |
| Drug-Eluting Permanent Defibrillator Electrodes (P980023/S110) | Biotronik, Inc. | 2021-12-20 |
| NEO 2101.U (P000009/S092) | Biotronik, Inc. | 2021-12-09 |
| NEO 2101.U (P950037/S225) | Biotronik, Inc. | 2021-12-09 |
| NEO 2101.U (P050023/S157) | Biotronik, Inc. | 2021-12-09 |
| NEO 2101.U (P070008/S126) | Biotronik, Inc. | 2021-12-09 |
| 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 (P950037/S230) | Biotronik, Inc. | 2021-10-29 |
| PHYLAX AV ICD SYSTEM (P980023/S109) | Biotronik, Inc. | 2021-10-29 |
| 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 (P070008/S132) | Biotronik, Inc. | 2021-10-29 |
| Iforia 7, Ilesto 5, Iforia 5, Itrevia 7, Iperia 7, Ilivia 7, Intica 7, Intica 5, Inlexa 3, Inventra 7, Itrevia 5, Iperia (P050023/S163) | Biotronik, Inc. | 2021-10-29 |
| Sentus QP leads (P070008/S129) | Biotronik, Inc. | 2021-09-03 |
| 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/S107) | Biotronik, Inc. | 2021-08-19 |
| Etrinsa 8 HF-T, Epyra 8 HF-T, Eluna 8 HF-T (P070008/S128) | Biotronik, Inc. | 2021-08-19 |