| PACEMAKER ICD CRT NON IMPLANTED COMPONENTS (P070008/S079) | Biotronik, Inc. | 2017-05-04 |
| Pacemaker/ICD/CRT non implanted components; PSW 1602.U; HMSC 3.34.0 (P000009/S068) | Biotronik, Inc. | 2017-05-03 |
| Various models of dual chamber ICDS in the Ilivia, Intica, Inlexa Families, Various models of CRT-Ds and Non- CRT-Ds in (P050023/S103) | Biotronik, Inc. | 2017-05-03 |
| Pacemaker/ICD/CRT non implanted components; PSW 1602.U; HMSC 3.34.0 (P070008/S075) | Biotronik, Inc. | 2017-05-03 |
| Pacemaker/ICD/CRT non implanted components PSW 1602.U, HMSC 3.34.0 (P950037/S166) | Biotronik, Inc. | 2017-05-03 |
| Kainox VCS; Linox TD 65/18 & 65/16; SD 75/18, 65/18, 65/18, 60/16; T65, S75,S65, S60; S DX 65/17; S DX 65/15; Protego DF (P980023/S080) | Biotronik, Inc. | 2017-03-29 |
| PSW 1601.U Pacemaker/ICD/CRT non implanted components (P050023/S104) | Biotronik, Inc. | 2017-03-24 |
| Edora 8, Evity 8, Enitra 8, Enticos 8 HF-T QPs,Edora 8, Evity 8, Enitra 8, Enticos 8 HF-Ts and PSW 1601.U Pacemaker/ICD/ (P070008/S076) | Biotronik, Inc. | 2017-03-24 |
| Edora 8 DR & DR-T, Evity 8 DR-T,Enitra 8 DR-T, Enticos 8 DR-T, Edora 8 SR-T and SR, Evity 8 SR-T, Enitra 8 SR-T,Enticos (P950037/S167) | Biotronik, Inc. | 2017-03-24 |
| PSW 1601.U Pacemaker/ICD/CRT non implanted components (P000009/S069) | Biotronik, Inc. | 2017-03-24 |
| PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P) (P070008/S077) | Biotronik, Inc. | 2017-02-10 |
| PULSE GENERATOR, PERMANENT, IMPLANTABLE (P950037/S169) | Biotronik, Inc. | 2017-02-10 |
| IPERIA 7 VR-T/INVENTRA 7 VR-T (DF-1); IPERIA 7 VR-T/INVENTRA 7 VR-T (DF4) (P050023/S101) | Biotronik, Inc. | 2017-02-08 |
| PHYLAX AV ICD SYSTEM (P000009/S067) | Biotronik, Inc. | 2017-02-08 |
| DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS (P950037/S164) | Biotronik, Inc. | 2017-02-08 |
| STRATOS LV CRT-P AND STRATOS LV-T CRT-P, COROX OTW BP LEAD AND COROX OTW-S BP LEAD (P070008/S074) | Biotronik, Inc. | 2017-02-08 |
| LINOX SMART/PROTEGO (ProMRI) S 65;LINOX SMART/PROTEGO (ProMRI) S 75;LINOX SMART/PROTEGO (ProMRI) SD 65/16;LINOX SMART/PR (P980023/S076) | Biotronik, Inc. | 2017-02-08 |
| PULSE GENERATOR, PACEMAKER, IMPLANTABLE WITH CARDIAC RESYNCHRONIZATION (CRT-P) (P070008/S080) | Biotronik, Inc. | 2017-01-31 |
| DEFIBRILLATOR, IMPLANTABLE, DUAL CHAMBER, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATION (P050023/S106) | Biotronik, Inc. | 2017-01-31 |
| PULSE GENERATOR, PERMANENT, IMPLANTABLE (P950037/S172) | Biotronik, Inc. | 2017-01-31 |
| PLEXA S 60, PLEXA SD 60/16, PLEXA PROMRI S 65, PLEXA PROMRI S 75, PLEXA PROMRI SD 65/16, PLEXA PROMRI SD 65/18, PLEXA PR (P980023/S075) | Biotronik, Inc. | 2017-01-05 |
| Protego TD 75/18, 65/18, 65/16; T 65; SD 75/18, 65/18, 65/16, 60/16, S75, S65, S60; Protego DF-1 TD 75/18, 65/18, 65/16; (P980023/S079) | Biotronik, Inc. | 2016-12-19 |
| Linox smart TD 75/18/ 65/18/ 65/16; Linox smart SD 75/18/ 65/18/ 65/16 60/16; Linox smart T65/ S75/ D65/S60; Linox smart (P950037/S170) | Biotronik, Inc. | 2016-12-19 |
| Reocor S, Reocor D (P950037/S168) | Biotronik, Inc. | 2016-10-21 |
| Permanent defibrillator electrodes (P980023/S078) | Biotronik, Inc. | 2016-10-03 |
| Protego SD 60/16, Protego SD 65/16, Protego SD 65/18, Protego SD 75/18, Protego TD 65/16, Protego TD 65/18, Protego TD 7 (P980023/S077) | Biotronik, Inc. | 2016-08-22 |
| PROMRI ICD/CRT-D SYSTEM (P050023/S100) | Biotronik, Inc. | 2016-08-01 |
| Iperia 7 HF-T (DF-1) Iperia 7 HF-T (DF4) Inventra 7 HF-T (DF-1) Inventra 7 HF-T (DF4) Defibrillator, Automatic Implantab (P050023/S102) | Biotronik, Inc. | 2016-07-27 |
| Solia S 45, 53, 60 Siello S 45, 53, 60 Drug-Eluting Permanent Right Ventricular (RV) or Right Atrial (RA) Pacemaker Elec (P950037/S165) | Biotronik, Inc. | 2016-07-26 |
| Various models of Evia, Entovis, Estella, Effecta, Ecuro, Eluna, Etrinsa, Epyra Pulse Generator Families (P950037/S163) | Biotronik, Inc. | 2016-06-24 |
| Stratos LV/LV-T, Evia/Entovis HF/HF-T, Eluna/Erinsa/Epyra 8 HF-T CRT-Ps (P070008/S073) | Biotronik, Inc. | 2016-06-24 |
| Various models of single chamber ICDS in the Lumax, Ilesto, Iforia, Iperia, Itrevia, Inventra Families, Various models o (P050023/S099) | Biotronik, Inc. | 2016-06-24 |
| PROMRI ICD SYSTEM (P050023/S095) | Biotronik, Inc. | 2016-06-16 |
| CARDIOMESSENGER SMART (P050023/S098) | Biotronik, Inc. | 2016-06-08 |
| SIELLO S 45, SIELLO S 53,SIELLO S 60,SOLIA S45,SOLIA S 53,SOLIA S60 (P950037/S156) | Biotronik, Inc. | 2016-06-08 |
| TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEAD (P050023/S097) | Biotronik, Inc. | 2016-05-27 |
| DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS (P950037/S162) | Biotronik, Inc. | 2016-05-27 |
| PHYLAX AV ICD SYSTEM (P000009/S066) | Biotronik, Inc. | 2016-05-27 |
| STRATOS LV CRT-P AND STRATOS LV-T CRT-P, COROX OTW BP LEAD AND COROX OTW-S BP LEAD (P070008/S072) | Biotronik, Inc. | 2016-05-27 |
| IPERIA 7 HF-T (DR-1) & (DF-4); INVENTRA 7 HF-T (DF-1) & (DF-4) (P050023/S094) | Biotronik, Inc. | 2016-05-02 |
| Drug-Eluting Permanent Defibrillator Electrodes, Accessories to Implantable Pacemaker Pulse Generator (P980023/S074) | Biotronik, Inc. | 2016-05-02 |
| SETROX S 53, SAFIO S 53 (P950037/S161) | Biotronik, Inc. | 2016-05-02 |
| PROGRAMMER SOFTWARE (1507.U) FOR THE ICS 3000/RENAMIC PROGRAMMERS (P000009/S065) | Biotronik, Inc. | 2016-05-02 |
| COROX OTW 75 BP & 85 BP; COROX OTW-L 75 BP & 85 BP; COROX OTW-S 75 BP & 85 BP (P070008/S070) | Biotronik, Inc. | 2016-05-02 |
| ACROS DR/SR/SLR/D/S,AXIOS DR/SR/SLR/D/S,BA03 DDDR,CYLOS DR/DR-T/VR,DROMOS DR/SR/SL,KAIROS DR/SR/SL/D/S,PHILOS DR/DR-T/S (P950037/S160) | Biotronik, Inc. | 2016-04-13 |
| IFORIA 5/7 DR-T/VR-T/VR-T DX; INVENTRA 7 DR-T/VR-T/VR-T DX; IPERIA 5/7 DR-T/VR-T/VR-T DX; LUMAX 300/340 DR/DR-T/VR/VR-T (P050023/S093) | Biotronik, Inc. | 2016-04-13 |
| BELOS DR/DR-T/VR-VR-T LEXOS DR/DR-T/VR-VR-T; LUMOS DR-T/VR-T; XELOS DR-T (P000009/S064) | Biotronik, Inc. | 2016-04-13 |
| STRATOS LV/LV-T, EVIA HF/HF-T; ENTOVIS HF/HF-T (P070008/S069) | Biotronik, Inc. | 2016-04-13 |
| TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEAD (P050023/S096) | Biotronik, Inc. | 2016-03-29 |
| STRATOS LV CRT-P AND STRATOS LV-T CRT-P, COROX OTW BP LEAD AND COROX OTW-S BP LEAD (P070008/S071) | Biotronik, Inc. | 2016-03-29 |
| PROTEGO SD 60/16,PROTEGO SD 65/16,PROTEGO SD 75/18,PROTEGO S 60,PROTEGO S 65,PROTEGO S 75,PROTEGO T 65,PROTEGO TD 65/16, (P980023/S066) | Biotronik, Inc. | 2016-01-28 |
| COROX OTW 75 UP STEROID, COROX OTW 85 UP STEROID (P050023/S089) | Biotronik, Inc. | 2016-01-28 |
| CELERITY 2D 75, CELERITY 2D 85,CELERITY 3D 75, CELERITY 3D 85, CELERITY PILOT 75, CELERITY PILOT 85, COROX OTW-L 75-BP, (P070008/S064) | Biotronik, Inc. | 2016-01-28 |
| SELOX SR 45,SELOX SR 53,SELOX SR 60,SELOX JT 45,SELOX JT 53,SELOX ST 53,SELOX ST 60,SETROX S 45,SETROX S 53,SETROX S 60, (P950037/S153) | Biotronik, Inc. | 2016-01-28 |
| IFORIA 7 DR-T (DF-1 & DF4), IPERIA 7 DR-T (DF-1 & DF-4), INVENTRA 7 DR-T (DF-1 & DF-4) (P050023/S087) | Biotronik, Inc. | 2015-12-21 |
| PROGRAMMER SOFTWARE(1503.U) FOR ICS 3000/RENAMIC PROGRAMMERS (P000009/S063) | Biotronik, Inc. | 2015-12-21 |
| PROGRAMMER SOFTWARE (1503.U) FOR THE ICS 3000/RENAMIC PROGRAMMERS (P070008/S063) | Biotronik, Inc. | 2015-12-21 |
| LINOX SMART S65,LINOX SMART SD 65/18,LINOX S DX 65/15,LINOX S DX 65/17,PROTEGO DF-1 S 65,PROTEGO DF-1 SD 65/18,PROTEGO D (P980023/S072) | Biotronik, Inc. | 2015-12-21 |
| LINOX SMART(S65)(SD65/18)(SDX65/15&65/17),PROTEGO DF-1(S65)(SD65/18)(DX65/15&65/17),PROTEGO(S65&75)(SD65/16,65/18,75/18) (P950037/S151) | Biotronik, Inc. | 2015-12-21 |
| BIOTRONIK ICD FAMILIES (P050023/S090) | Biotronik, Inc. | 2015-12-18 |
| PROTEGO DF-1 LEAD FAMILY (P980023/S070) | Biotronik, Inc. | 2015-10-29 |
| SETROX S 45, SETROX S 53, SETROX S 60, DEXTRUS 4135, DEXTRUS 4136, DEXTRUS 4137, SAFIO S 53, SAFIO S 60, TILDA JT45, TIL (P950037/S158) | Biotronik, Inc. | 2015-08-31 |
| COROX OTW 75-BP, COROX OTW 85-BP, COROX OTW-S 75-BP, COROX OTW-S 85-BP, COROX OTW-L 85-BP, COROX OTW-L 75-BP, CELERITY 2 (P070008/S068) | Biotronik, Inc. | 2015-08-31 |
| LINOX SMART SD 60/16, LINOX SMART SD 65/16, LINOX SMART SD 65/18, LINOX SMART SD 75/18, LINOX SMART TD 65/16, LINOX SMAR (P980023/S073) | Biotronik, Inc. | 2015-08-31 |
| COROX OTW 75-UP STEROID,COROX OTW 85 UP STEROID (P050023/S084) | Biotronik, Inc. | 2015-07-17 |
| SLX 58/11-BP, SLX 58/13-BP,SLX 58/14-BP,SLX 58/15-BP,SLX 58/17-BP,SLX 65/11-BP,SLX 65/13-BP,SLX 65/14-BP,SLX 65/15-BP,SL (P950037/S149) | Biotronik, Inc. | 2015-07-17 |
| KAINOX VCS,PROTEGO SD (60/16)(65/16),(65/18)(75/18), PROTEGO TD (65/16)(65/18)(75/18), PROTEGO S (60/65/75)PROTEGO T 65 (P980023/S065) | Biotronik, Inc. | 2015-07-17 |
| PROTEGO (S/SD/T/TD) ICD LEAD (P980023/S071) | Biotronik, Inc. | 2015-07-17 |
| COROX OTW 75-BP, COROX OTW 85-BP,COROX OTW-S 75-BP,COROX OTW-S 85-BP,COROX OTW-L 75-BP,COROX OTW-L 85-BP (P070008/S061) | Biotronik, Inc. | 2015-07-17 |
| PROTEGO SD 60/16, PROTEGO SD 65/16, PROTEGO SD 65/18, PROTEGO SD 75/18, PROTEGO TD 65/16, PROTEGO TD 65/18, PROTEGO TD (P980023/S069) | Biotronik, Inc. | 2015-07-07 |
| EVIA HF,EVIA HF-T, ENTOVIS HF,ENTOVIS HF-T (P070008/S067) | Biotronik, Inc. | 2015-07-07 |
| EVIA DR, EVIA DR-T, EVIA SR, EVIA SR-T, ENTOVIS DR, ENTOVIS DR-T, ENTOVIS SR, ENTOVIS SR-T, ESTELLA DR, ESTELLA DR-T, ES (P950037/S157) | Biotronik, Inc. | 2015-07-07 |
| ENTOVIS DR, ENTOVIS DR-T, ENTOVIS SR, ENTOVIS SR-T, EVIA DR, EVIA DR-T, EVIA SR,EVIA SR-T, ESTELLA DR, ESTELLA DR-T, EST (P950037/S155) | Biotronik, Inc. | 2015-06-22 |
| ELUNA 8 HF-T,ETRINSA 8 HF-T, EPYRA 8 HF-T,EVIA HF-T,STRATOS LV,COROX OTW 75-BP,COROX OTW 85BP,COROX OTW-S 75-BP,COROX OT (P070008/S066) | Biotronik, Inc. | 2015-06-22 |
| IPERIA 7 VR-T (DF-1),IPERIA 7 VR-T (DF-4),ITREVIA 7 VR-T (DF-1),ITREVIA 7 VR-T (DF-4),INVENTRA 7 VR-T (DF-1),INVENTRA 7 (P050023/S092) | Biotronik, Inc. | 2015-06-22 |
| LINOX SMART SD 60/16,LINOX SMART SD 65/16,LINOX SMART SD 65/18,LINOX SMART SD 75/18,LINOX SMART TD 65/16,LINOX SMART TD (P980023/S068) | Biotronik, Inc. | 2015-06-22 |
| INVENTRA CRT-D (P050023/S085) | Biotronik, Inc. | 2015-06-19 |
| PHYLAX AV ICD SYSTEM (P000009/S062) | Biotronik, Inc. | 2015-06-19 |
| STRATOS LV/LV-T CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRP-T) SYSTME (P070008/S062) | Biotronik, Inc. | 2015-06-19 |
| DROMOS DRISK RATE ADAPTIVE PACEING SYSTEM (P950037/S150) | Biotronik, Inc. | 2015-06-19 |
| EVIA HF, EVIA HF-T, ENTOVIS HF, ENTOVIS HF-T (P070008/S065) | Biotronik, Inc. | 2015-06-12 |
| LINOX SMART SD 60/16,LINOX SMART SD 65/16,LINOX SMART SD 65/18,LINOX SMART SD 75/18,LINOX SMART TD 65/16, LINOX SMART TD (P980023/S067) | Biotronik, Inc. | 2015-06-12 |
| ILESTO 7 HF-T, ILESTO 5 HF-T, IFORIA 7 HF-T IFORIA 5 HF-T, INVENTRA 7 HF-T (DF-1), INVENTRA 7 HF-T (DF4), IPERIA 7HF-T ( (P050023/S091) | Biotronik, Inc. | 2015-06-12 |
| EVIA DR, EVIA DR-T, EVIA SR, EVIA SR-T, ENTOVIS DR, ENTOVIS DR-T, ENTOVIS SR, ENTOVIS SR-T, ESTELLA DR, ESTELLA DR-T, ES (P950037/S154) | Biotronik, Inc. | 2015-06-12 |
| LUMAX DR-T, LUMAX VR-T AND LUMAX CRT-D (P050023/S086) | Biotronik, Inc. | 2015-05-27 |
| CARDIOMESSENGER, RELIATY, RENAMIC, REOCOR (P950037/S152) | Biotronik, Inc. | 2015-05-14 |
| CARDIOMESSENGER (P050023/S088) | Biotronik, Inc. | 2015-05-14 |
| IFORIA/ILESTO/INVENTRA/IPERIA/ITREVIA 5/7 DR-T/VR-T/VR-T DX, & VARIOUS LUMAX ICDS; IFORIA/ILESTO/IPERIA/ITREVIA 5/7 HF-T (P050023/S083) | Biotronik, Inc. | 2015-04-09 |
| STATOS LV/LV-T, EVIA/ENTOVIS HF/HF-T (P070008/S060) | Biotronik, Inc. | 2015-04-09 |
| BELOS/LEXOS DR/DR-T/VR/VR-T, LUMOS DR-T/VR-T, XELOS DR-T (P000009/S061) | Biotronik, Inc. | 2015-04-09 |
| ACTROS/AXIOS DR/SR/SLR/D/S, BA03 DDDR, CYLOS DR/DR-T/VR, DROMOS DR/SR/SL, KAIROS DR/SR/SL/D/S, PHILOS DR/D (P950037/S148) | Biotronik, Inc. | 2015-04-09 |
| STRATOS LV/LV-T, EVIA HF/HF-T, ENTOVIS HF/HF-T CRT-P'S (P070008/S057) | Biotronik, Inc. | 2015-03-19 |
| ENTOVIS DR-T,DR,SR-T,SR; ELUNA 8 DR-T PROMRI,DR PROMRI,SR-T PRMRI,SR PROMRI;SETROX S53,S60;SAFIO S53,S60 (P950037/S142) | Biotronik, Inc. | 2015-03-19 |
| BELOS DR/DR-T/VR/VR-T, LEXOS DR/DR-T/VR/VR-T, LUMOS DR-T/VR-T, XELOS DR-T ICD'S (P000009/S060) | Biotronik, Inc. | 2015-03-19 |
| IFORIA/ILESTO 5/7 DR-T/VR-T/VR-T DX/HF-T; KRONOS LV-T, VARIOUS LUMAX MODELS CRT-D'S (P050023/S081) | Biotronik, Inc. | 2015-03-19 |
| SELOX JT 45 /JT53; ST53/ST60;TILDA R45, R53,R60; SAFIO S53, S60; TILDA JT45,53, TILDA T53,60; DRUG ELUTING PERMANENT RIG (P950037/S147) | Biotronik, Inc. | 2015-02-20 |
| LINOX SMART SD60/16; SD 65/16; 65/18, 75/18; S60, S65, S75, S DX 65/15, 65/17, T65, TD 65/16, 65/18, VOLTA TA ICR60,65,7 (P980023/S064) | Biotronik, Inc. | 2015-02-20 |
| CELERITY 2D 75, 2D 85, 3D75, 3D85, PIOLOT 75,85; COROX OTW 75-UP STEROID, 85-UP, 85-BP, D75-BP (P070008/S059) | Biotronik, Inc. | 2015-02-20 |
| IPERIA FAMILY ICD/CRT-D: IPERIA ITREVIA AND INVENTRA (P050023/S079) | Biotronik, Inc. | 2015-02-10 |
| DROMOS DR/SR RATE ADAPTIVE PACING SYSTEM (P950037/S139) | Biotronik, Inc. | 2015-02-10 |