| PSW 1901.U (P000009/S079) | Biotronik, Inc. | 2019-07-18 |
| PSW 1901.U (P050023/S130) | Biotronik, Inc. | 2019-07-18 |
| PSW 1901.U (P070008/S101) | Biotronik, Inc. | 2019-07-18 |
| Phylax ICD System (P980023/S092) | Biotronik, Inc. | 2019-05-24 |
| Pulse Geneerator, Permanent, Implantable (P950037/S201) | Biotronik, Inc. | 2019-05-07 |
| Tupos LV/ATx and Kronos LV-T CRT-D System (P050023/S131) | Biotronik, Inc. | 2019-05-07 |
| Stratos LV/LV-T CRT-P System (P070008/S103) | Biotronik, Inc. | 2019-05-07 |
| Corox (ProMRI0 OTW,75,85,S75,L75,LB85 BP; Sentus (ProMRI) OTW,75,85,S75,S85,L75,L85,QP S75S85,S95,l75,l85,L95,S75/49,S75 (P070008/S099) | Biotronik, Inc. | 2019-04-29 |
| Plexa ProMRI DF- S DX 65/15/17; IIivia 7 DR-T; Inrica 5 DTR-T (P980023/S087) | Biotronik, Inc. | 2019-04-29 |
| IIivia, 7 HF-T,QP; Intica 7,5 HF-T,QP (P050023/S126) | Biotronik, Inc. | 2019-04-29 |
| Setrox S 53; Safio S 53; Dextrus 4136;TILDA R53;Solia S 45/53/60, JT 45/53; Siello S53/60/45/53/60/,JT 45/53; (P950037/S198) | Biotronik, Inc. | 2019-04-29 |
| Protego TD, SD 75/18, 65/18, 65/16 and SD 60/16 Protego T 65, and S 75, 65, 60 Plexa S 60, PLexa SD 60/16, Plexa ProMRI (P980023/S091) | Biotronik, Inc. | 2019-04-16 |
| Sentus ProMRI OTW QP S-75, 85, 95, L-75, 85, 95, Sentus ProMRI OTW QP S-75/49, 85/49, 95/49, L-75/49, 85/49, 9/49 and Se (P070008/S102) | Biotronik, Inc. | 2019-04-16 |
| Permanent Defibrillator Electrodes: Protego SD, Protego TD, Protego S and Protego T (P980023/S090) | Biotronik, Inc. | 2019-04-15 |
| Siello S45, S53, S60 and Solia S45, S53, S60 (P950037/S199) | Biotronik, Inc. | 2019-04-15 |
| Ilesto 7 VR-T, Iforia 7 VR-T, Ilesto 5 VR-T, Iforia 5 VR-T, Inventra 7 VR-T, Iperia 7 VR-T, Itrevia 7 VR-T, Iperia 5 VR- (P050023/S128) | Biotronik, Inc. | 2019-04-15 |
| PSW 1803.U /HMSC 3.40.2 / CardioMessenger Smart (P070008/S098) | Biotronik, Inc. | 2019-03-13 |
| PSW 1803.U / HMSC 3.40.2 / CardioMessenger Smart (P950037/S197) | Biotronik, Inc. | 2019-03-13 |
| PSW 1803.U / HMSC 3.40.2 /CardioMessenger Smart (P000009/S078) | Biotronik, Inc. | 2019-03-13 |
| Acticor 7 VR-T / Rivacor 7 VR-T /5VR-T /3 VR-T / Acticor 7 VR-T DX / Rivacor 7 VR-T DX /Rivacor 5 VR-T DX ; Acticor 7 DR (P050023/S125) | Biotronik, Inc. | 2019-03-13 |
| Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) (P070008/S100) | Biotronik, Inc. | 2019-02-25 |
| Defibrillator, Implantable Cardioverter, with Cardiac Resynchronization (Crt-D); Defibrillator, Implantable, Dual-Chambe (P050023/S129) | Biotronik, Inc. | 2019-02-25 |
| Plexa ProMRI S DX ICD Leads (P980023/S089) | Biotronik, Inc. | 2019-02-21 |
| Evia DR/SR; Evia DR-T/SR-T; Entovis DR/SR, Entovis DR-T/SR-T; Estella DR/SR; Estella DR-T/SR-T; Effecta D/S; Edora 8 DR/ (P950037/S192) | Biotronik, Inc. | 2019-02-12 |
| Evia HF/ HF-T; Entovis HF/ HF-T; Edora 8 HF-T; Enitra 8 HF-T; Enticos 8 HF-T; Evity 8 HF-T; Etrinsa 8 HF T; Epyra 8 HF-T (P070008/S094) | Biotronik, Inc. | 2019-02-12 |
| EFH-16; S 60-K; S 60-J; S 60-S (P820076/S027) | Biotronik, Inc. | 2019-02-12 |
| Ilesto 7 VR-T; Iforia 7 VR-T; Ilesto 5 VR-T; Iforia 5 VR-T; Ilesto 7 VR T DX; Iforia 7 VR-T DX; Ilesto 5 VR-T DX; Iforia (P050023/S121) | Biotronik, Inc. | 2019-02-12 |
| Protego SD/TD; Protego DF-1 SD; Protego ProMRI SDX; Protego DF-1 ProMRI SD; Plexa SD; Plexa ProMRI SD; Plexa DF-1 SD; Pl (P980023/S085) | Biotronik, Inc. | 2019-02-12 |
| Accessory to Defibrillator, Automatic Implantable Cardioverter, with Cardiac Resynchronization (CRT-D) (P050023/S116) | Biotronik, Inc. | 2018-12-19 |
| Pulse Generator, Pacemaker, Implatable, with Cardiac Resynchronization (CRT-P), Drug Eluting Permanent Left Ventricular (P070008/S090) | Biotronik, Inc. | 2018-12-19 |
| Pulse Generator, Permanent Implantable, Drug-Eluting Permanent Right Ventricular (RV) or Right Atrial (RA) Pacemaker Ele (P950037/S186) | Biotronik, Inc. | 2018-12-19 |
| Defibrillator, Automatic Implantable Cardioverter with Cardiac Resynchronization (CRT-D) (P050023/S127) | Biotronik, Inc. | 2018-12-13 |
| Implantable Cardioverter Defibrillatory (Non-CRT) and Defibrillatort, Implantable, Dual-Chamber (P980023/S088) | Biotronik, Inc. | 2018-12-13 |
| IFORIA 5/7, ILESTO 57/, INVENTRA 7, IPERIA 5/7, ITREVIA 5/7, ILIVIA 5/7, INTICA 5/7, INLEXA 5/7, LUMAX 300/340 and 500/5 (P050023/S124) | Biotronik, Inc. | 2018-10-22 |
| PSW 1802.U, ACTROS, AXOS, BA03, CYLOS, DROMOS, KAIROS, PHILOS, PHILOS II, PROTOS, EVIA, ENTOVIS, ECURO, EFFECTA, ESTELLA (P950037/S195) | Biotronik, Inc. | 2018-10-22 |
| STRATOS, EVIA, ENTOIVS, ELUNA 8, EPYRA 8, and ETRINSA 8 (P070008/S097) | Biotronik, Inc. | 2018-10-22 |
| BELOS, LEXOS, LUMOS, and XELOS (P000009/S077) | Biotronik, Inc. | 2018-10-22 |
| Siello S 45/53/60, Solia S 45/53/60, Siello T 53/60, Siello JT 45/53, Solia T 53/60, Solia JT 45/53, EFH-6F-W (P950037/S196) | Biotronik, Inc. | 2018-10-03 |
| Siello T 53; Siello T 60; Siello JT 45; Siello JT 53; Solia T 53; Solia T 60; Solia JT 45; Solia JT 53 (P070008/S096) | Biotronik, Inc. | 2018-08-27 |
| Siello T 53; Siello T 60; Siello JT 45; Siello JT 53; Solia T 53; Solia T 60; Solia JT 45; Solia JT 53 (P050023/S123) | Biotronik, Inc. | 2018-08-27 |
| Siello T 53; Siello T 60; Siello JT 45; Siello JT 53; Solia T 53; Solia T 60; Solia JT 45; Solia JT 53 (P950037/S194) | Biotronik, Inc. | 2018-08-27 |
| PSW 1801.U (P000009/S076) | Biotronik, Inc. | 2018-08-15 |
| PSW 1801.U (P070008/S092) | Biotronik, Inc. | 2018-08-15 |
| PSW 1801.U (P050023/S119) | Biotronik, Inc. | 2018-08-15 |
| PSW 1801.U (P950037/S190) | Biotronik, Inc. | 2018-08-15 |
| S 75-G OTW; S 75-K OTW; S 85-G OTW; S 85-K OTW (P050023/S122) | Biotronik, Inc. | 2018-08-09 |
| EFH-16; S60-K; S 60-J; S 60-S (P820076/S028) | Biotronik, Inc. | 2018-08-09 |
| Corox OTW BP; Corox OTW-L BP; Corox ProMRI OTW BP; Sentus ProMRI OTW QP S; Sentus ProMRI OTW QP S-xx/49; Corox OTW-S BP; (P070008/S095) | Biotronik, Inc. | 2018-08-09 |
| Protego SD; Protego TD; Protego DF-1 SD; Protego ProMRI SDx; Protego DF-1; ProMRI SD; Plexa SD; Plexa ProMRI SD; Plexa D (P980023/S086) | Biotronik, Inc. | 2018-08-09 |
| Selox ST/JT; Siello S; Solia S; Setrox S; Safio S; S 45-K/53-K; DH; DH IS-1/DF4; EFH-6F-W; S53-K; S 45-S; S 53-S; S 45-F (P950037/S193) | Biotronik, Inc. | 2018-08-09 |
| Evia DR,DR-T,SR,SR-T; Entovis DR,DR-T,SR-T; Estella DR,DR-T,SR,SR-T; Effecta D,S; Edora 8 DR, 8 SR; Etrinsa 8 DR-T,SR-T, (P950037/S187) | Biotronik, Inc. | 2018-06-19 |
| Evia HF, HF-T, Entovis HF, HF-T, Edora 8 HF-T, Enitra HF-T, Etrinsa 8 HF-T, Epyra 8 HF-T, Eluna 8 HF-T, Edora 8 HF-T QP, (P070008/S091) | Biotronik, Inc. | 2018-06-19 |
| lesto 7 DR-T, lperia 7 DR-T, lforia 7 DR-T, lnventra 7 DR-T, llesto 5 DR-T, ltrevia 5 DR-T, lforia 5 DR-T, lperia 5 DR-T (P050023/S117) | Biotronik, Inc. | 2018-06-19 |
| Evia HF /HF-T; Entovis HF/ HF-T ; Edora 8 HF-T; Entira 8 HF-1; Etrinsa 8 HF-T; Epyra 8 HF-T; Eluna 8 HF-T; Edora 8HF-T Q (P070008/S093) | Biotronik, Inc. | 2018-06-13 |
| llesto 7 VT-T / 5 VR-T , 7 VR-T DX; Ifora 7 VR-T /5 VR-T /7 VR-T DX , 5 VR-T DX ; Itrevia 7 VT-T/ DX (GBLi), Intica 5 VR (P050023/S120) | Biotronik, Inc. | 2018-06-13 |
| Evia DR /DR-T /SR/SR-T ;/Entovis DR /DR-T /SR /SR-T; Estella DR / DR-T/ SR /SR-T; Effecta D /S ;/ Endora 8 DR/ 8 SR; / (P950037/S191) | Biotronik, Inc. | 2018-06-13 |
| Siello S 45, Siello S 53, Siello S 60, Solia S 45, Solia S 53, Solia S 60 (P950037/S189) | Biotronik, Inc. | 2018-06-12 |
| Inlexa 7 VR-T, Inlexa 3 VR-T, Llivia 7 VR-T, Intica 7 VR-T, Intica 5 VR-T, Iperia 7 VR-T, Itrevia 5 VR-T, Inventra 7 VR- (P050023/S118) | Biotronik, Inc. | 2018-03-30 |
| Selox ST/JT; Siello S; Setrox S, Solia S, Safio S (P950037/S185) | Biotronik, Inc. | 2018-02-21 |
| TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEAD (P050023/S115) | Biotronik, Inc. | 2018-02-21 |
| DIPLOS MODEL 05 A & B (P820076/S026) | Biotronik, Inc. | 2018-02-21 |
| Corox OTW BP/OTW-S BP; Corox OTW-L BP/ProMRI OTW-L BP; Corox ProMRI OTW BP/ProMRI OTW-SBP; Sentus ProMRI OTW QP S/ProMRI (P070008/S089) | Biotronik, Inc. | 2018-02-21 |
| Protego SD/TD/S/T; Protego DF-1 SD/DF-1S; Protego ProMRI SDX/DF-1 ProMRI SDX; Protego DF-1 ProMRI SD/DF-1 ProMRI S; Plex (P980023/S084) | Biotronik, Inc. | 2018-02-21 |
| Stratos LV CRT-P / Stratos LV-T CRT-P / Corox OTW BP Lead / Corox OTW-S BP Lead (P070008/S088) | Biotronik, Inc. | 2018-02-15 |
| Tupoa LV/ATX & Kronos LV-T / CRT-D & Corox OWT Steroid LV Pacing Lead (P050023/S114) | Biotronik, Inc. | 2018-02-15 |
| Phylax Implantable Cardioverter Defibrillator System (P980023/S082) | Biotronik, Inc. | 2018-02-15 |
| Dromos DR/DR-A and Dromos SR/SR-B Cardiac Pacing System (P950037/S183) | Biotronik, Inc. | 2018-02-15 |
| Linox Smart, Protego, and Plexa (P980023/S083) | Biotronik, Inc. | 2017-12-19 |
| Siello, Solia, Setrox, and Safio (P950037/S184) | Biotronik, Inc. | 2017-12-19 |
| PSW 1704.U (P070008/S087) | Biotronik, Inc. | 2017-12-12 |
| PSW 1704.U (P950037/S182) | Biotronik, Inc. | 2017-12-12 |
| PSW 1704.U (P050023/S113) | Biotronik, Inc. | 2017-12-12 |
| PSW 1704.U (P000009/S075) | Biotronik, Inc. | 2017-12-12 |
| Siello S and Solia S, EFH-6F-W and DH IS-1/DF4 (P950037/S181) | Biotronik, Inc. | 2017-11-08 |
| PK-222 and PK-Electrode Clip (accessory to Renamic) (P950037/S180) | Biotronik, Inc. | 2017-09-11 |
| PSW 1703.U (P000009/S074) | Biotronik, Inc. | 2017-08-31 |
| PSW 1703.U (P070008/S085) | Biotronik, Inc. | 2017-08-31 |
| PSW 1703.U (P950037/S179) | Biotronik, Inc. | 2017-08-31 |
| PSW 1703.U (P050023/S112) | Biotronik, Inc. | 2017-08-31 |
| Blind plug BS IS4 (P050023/S111) | Biotronik, Inc. | 2017-08-16 |
| Setrox S53, S60, Safio S 53, S 60, Solia S 45, S 53, S 60, Siello S 45, S 53, s 60, Blind plug BS IS-1 (P950037/S177) | Biotronik, Inc. | 2017-08-16 |
| Edora 8 HF-T QP, Edora 8 HF-T/QP, Evity 8 HF-T/QP,Evity 8 HF-T/QP, Corox (ProMRI) OTW 85 BP, L85 BP, S 85 BP, Sentus (Pr (P070008/S084) | Biotronik, Inc. | 2017-08-16 |
| Llivia, Inlexa, Intica 7/5, VR-T/ DR-T DF4 (P050023/S109) | Biotronik, Inc. | 2017-08-02 |
| Edora, Evity, Enitra, Enticos 8 HF-T/ QP (P070008/S083) | Biotronik, Inc. | 2017-08-02 |
| Sentus ProMRI OTW QP S-75, S-85, S-95, L-75, L-95, S-75/49, S-85/49, S-95/49, L-75/49, L-85/49 and Sentus ProMRI OTW QP (P070008/S086) | Biotronik, Inc. | 2017-07-27 |
| ProMRI ICD/CRT-D System (P050023/S110) | Biotronik, Inc. | 2017-07-21 |
| Siello S 45, S53, S60 / Solia S 45, S53, S 60 (P950037/S178) | Biotronik, Inc. | 2017-06-23 |
| Solia S (P950037/S174) | Biotronik, Inc. | 2017-05-24 |
| Plexa S 60/Plexa SD 60/16/Plexa ProMRI S/Plexa ProMRI SD/Plexa DF-1 S/Plexa DF-1 SD/Plexa ProMRI DF-1 SD/Plexa ProMRI DF (P980023/S081) | Biotronik, Inc. | 2017-05-24 |
| Pacemaker ICD CRT Non Implanted components. (P000009/S071) | Biotronik, Inc. | 2017-05-06 |
| Edora / Enitra /Enticos / Evity PSW 1701.U (P950037/S175) | Biotronik, Inc. | 2017-05-06 |
| Defibrillator, Implantable, Dual Chamber, Automatic Implantable Cardioverter with Cardiac Resynchronization (P050023/S107) | Biotronik, Inc. | 2017-05-06 |
| Eluna / Epyra / Etrinsa (P070008/S082) | Biotronik, Inc. | 2017-05-06 |
| Lumos DR-T/VR-T (P000009/S072) | Biotronik, Inc. | 2017-05-06 |
| Inventra / Iperia / Itrevia (P050023/S108) | Biotronik, Inc. | 2017-05-06 |
| Pulse Generator, Permanent Implantable (P950037/S173) | Biotronik, Inc. | 2017-05-06 |
| Pulse Generator, Pacemaker, Implantable with Cardiac Resynchronization (CRT_P) (P070008/S081) | Biotronik, Inc. | 2017-05-05 |
| PACEMAKER ICD CRT NON IMPLANTED COMPONENTS (P050023/S105) | Biotronik, Inc. | 2017-05-04 |
| PACEMAKER ICD CRT NON IMPLANTED COMPONENTS (P000009/S070) | Biotronik, Inc. | 2017-05-04 |
| PACEMAKER/ICD/CRT NON IMPLANTED COMPONENTS (P950037/S171) | Biotronik, Inc. | 2017-05-04 |