| CURRENT+ ELLIPSE, FORTIFY ASSURA FAMILIES OF THE ICD DEVICES (P910023/S370) | ABBOTT MEDICAL | 2016-04-21 |
| PROMOTE+ QUADRA ASSURA , UNIFY ASSURA, UNIFY QUADRA FAMILIES OF CRT-D DEVICES (P030054/S301) | ABBOTT MEDICAL | 2016-04-21 |
| CORDIS PRECISE NITINOL STENT SYSTEM (P030047/S032) | Cordis US Corporation | 2016-04-20 |
| EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (EVERFLEX) (P110023/S018) | Medtronic Vascular, Inc. | 2016-04-20 |
| VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM (P960040/S367) | Boston Scientific | 2016-04-20 |
| S.M.A.R.T. AND S.M.A.R.T. CONTROL NITINOL STENT SYSTEM (P020036/S036) | Cordis US Corporation | 2016-04-20 |
| SMA RT CONTROL AND SMART VASCULAR STENT SYSTEMS (P120002/S012) | Cordis US Corporation | 2016-04-20 |
| CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL (P010012/S413) | Boston Scientific Corp | 2016-04-20 |
| IN PACT ADMIRAL PACLITAXEL-ELUTING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER (P140010/S016) | Medtronic, Inc. | 2016-04-19 |
| REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM (P130030/S019) | Boston Scientific Corp | 2016-04-19 |
| PROMUS PREMIER EVEROLIMUS-ELUTING PLANTINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S118) | Boston Scientific Corp | 2016-04-19 |
| EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEM (P020025/S086) | Boston Scientific | 2016-04-19 |
| BOSTON SCIENTIFIC EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S073) | Boston Scientific Corp | 2016-04-19 |
| CapSureFix Novus Lead 5076; Vitatron Crystalline (P930039/S150) | Medtronic, Inc. | 2016-04-18 |
| SYNCARDIA CAMPANION 2 DRIVER SYSTEM (P030011/S039) | Syncardia Systems, LLC | 2016-04-15 |
| BRAVA CRT-D,BRAVA QUAD CRT-D,VIVA QUAD S CRT-D,VIVA QUAD XT CRT-D,VIVA S CRT-D,VIVA XT CRT-D,CRT-D MRI AMPLIA,CRT-D MRI (P010031/S530) | Medtronic Cardiac Rhythm Disease Management | 2016-04-15 |
| XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S084) | Abbott Vascular | 2016-04-15 |
| EVERA MRI ICD,EVERA S DR ICD,EVERA S VR ICD,EVERA XT DR ICD,EVERA XT VR ICD,VISIA AF VR,VISIA AF S VR,VISIA AF MRI VR SU (P980016/S569) | Medtronic Cardiac Rhythm Disease Management | 2016-04-15 |
| XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S083) | Abbott Vascular | 2016-04-15 |
| RESOLUTE MICROTRAC/RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S064) | Medtronic Vascular | 2016-04-14 |
| MEDTRONIC ATTAIN ABILITY MODEL 4196 LEAD (P080006/S091) | Medtronic, Inc. | 2016-04-14 |
| THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER AND IBI 1500T9-CP V1.6 CARDIAC ABLATION GENERATOR (P110016/S031) | ABBOTT MEDICAL | 2016-04-14 |
| Dynagen, Inogen, Origen Implantable Cardiac Defibrillators (ICDs) (P960040/S368) | Boston Scientific | 2016-04-14 |
| ZILVER PTX DRUG-ELUTING PERIPHERAL STENT (P100022/S017) | Cook Ireland, Ltd. | 2016-04-14 |
| Dynagen, Inogen, Origen Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) (P010012/S414) | Boston Scientific Corp | 2016-04-14 |
| SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM & LASER SHEATH (P960042/S053) | Spectranetics (Philips) | 2016-04-13 |
| 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 |
| ASTRON PERIPHERAL SELF-EXPANDING NITINOL STENT SYSTEM (P140030/S002) | Biotronik AG | 2016-04-13 |
| DRIVER OVER-THE-WIRE, RAPID EXCHANGE, AND MULTI-EXCHANGE CORONARY STENT SYSTEMS (P030009/S085) | Medtronic, Ireland | 2016-04-13 |
| VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS (P980016/S580) | Medtronic Cardiac Rhythm Disease Management | 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 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES (P130009/S052) | Edwards Lifesciences, LLC | 2016-04-13 |
| SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM (P910001/S085) | Spectranetics Corp. | 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 |
| CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION (P010031/S541) | Medtronic Cardiac Rhythm Disease Management | 2016-04-13 |
| STRATOS LV/LV-T, EVIA HF/HF-T; ENTOVIS HF/HF-T (P070008/S069) | Biotronik, Inc. | 2016-04-13 |
| THE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEM (P000039/S054) | ABBOTT MEDICAL | 2016-04-12 |
| AMPLATZER MUSCULAR VSD OCCLUDER (P040040/S027) | ABBOTT MEDICAL | 2016-04-12 |
| TACTICATH QUARTZ SET (P130026/S019) | St Jude Medical | 2016-04-12 |
| AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEM (P020024/S044) | ABBOTT MEDICAL | 2016-04-12 |
| CapSure SP Novus Lead 5092, 5592, 5594; CapSure Z Novus Lead 5054, 5554 (P850089/S117) | Medtronic Cardiac Rhythm Disease Management | 2016-04-12 |
| LIVEWIRE(R) CARDIAC ABLATION SYSTEM (P960016/S063) | St Jude Medical | 2016-04-12 |
| THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER AND IBI 1500T9-CP V1.6 CARDIAC ABLATION GENERATOR (P110016/S030) | ABBOTT MEDICAL | 2016-04-12 |
| INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM (P140028/S009) | Boston Scientific Corporation | 2016-04-12 |
| AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEM (P020024/S043) | ABBOTT MEDICAL | 2016-04-12 |
| CapSure Sense Lead 4074, 4574; CapSure SP Novus Lead 4092, 4592 (P830061/S128) | Medtronic Cardiac Rhythm Disease Management | 2016-04-12 |
| TRIDYNE VASCULAR SEALANT (P150016) | Neomend, Inc. | 2016-04-11 |
| EXCLUDER AAA ENDOPROSTHESIS (P020004/S128) | W. L. Gore & Associates, Inc. | 2016-04-08 |
| MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEM (P010015/S296) | Medtronic, Inc. | 2016-04-08 |
| MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWARE (P980035/S459) | Medtronic, Inc. | 2016-04-08 |
| REVO MRI SURESCAN IPG AND PACING SYSTEM (P090013/S222) | Medtronic, Inc. | 2016-04-08 |
| SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P150003/S008) | Boston Scientific Corporation | 2016-04-08 |
| EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEM (P020025/S085) | Boston Scientific | 2016-04-08 |
| SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM (P910001/S084) | Spectranetics Corp. | 2016-04-07 |
| IMPELLA LEFT VENTRICULAR SUPPORT SYSTEM (P140003/S005) | Abiomed, Inc. | 2016-04-07 |
| SYNERGY EVEROLIMUS ELUTING PLATINUM CHROMIUN CORONARY STENT SYSTEM MONORAIL & OVER THE WIRE. (P150003/S002) | Boston Scientific Corporation | 2016-04-07 |
| GORE VIABAHN ENDOPROSTHESIS AND ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P130006/S029) | W. L. Gore & Associates, Inc. | 2016-04-07 |
| IMPELLA VENTRICULAR SUPPORT SYSTEMS (P140003/S004) | Abiomed, Inc. | 2016-04-07 |
| BIOGLUE SURGICAL ADHESIVE (P010003/S020) | Cryolife, Inc. | 2016-04-07 |
| VIABAHN ENDOPROSTHESIS (P040037/S090) | W. L. Gore & Associates, Inc. | 2016-04-07 |
| EXCLUDER AAA ENDOPROSTHESIS (P020004/S127) | W. L. Gore & Associates, Inc. | 2016-04-07 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES (P130009/S054) | Edwards Lifesciences, LLC | 2016-04-06 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S083) | W. L. Gore & Associates, Inc. | 2016-04-06 |
| MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM (P150033) | Medtronic, Inc. | 2016-04-06 |
| TALENT THORACIC STENT GRAFT SYSTEM (P070007/S038) | Medtronic Vascular | 2016-04-05 |
| WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY (P130013/S006) | Boston Scientific Corp | 2016-04-05 |
| THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (P060040/S054) | ABBOTT MEDICAL | 2016-04-05 |
| BLAZER OPEN-IRRIGATED ABLATION CATHETER (P150005/S003) | Boston Scientific Corp | 2016-04-05 |
| MITRACLIP CLIP DELIVERY SYSTEM (P100009/S016) | ABBOTT MEDICAL | 2016-04-05 |
| EXCLUDER BIFURCATED ENDOPROSTHESIS (P020004/S129) | W. L. Gore & Associates, Inc. | 2016-04-04 |
| Sprint Quattro Lead 6946M; Sprint Quattro Lead 6935, 6935M, 6944, 6947, 6947M (P920015/S176) | Medtronic, Inc. | 2016-04-04 |
| ARTEGRAFT COLLAGEN VASCULAR GRAFT (N16837/S019) | LeMaitre Vascular, Inc. | 2016-04-04 |
| HEARTLIGHT ENDOSCOPIC ABLATION SYSTEM (P150026) | Cardiofocus, Inc. | 2016-04-01 |
| XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S082) | Abbott Vascular | 2016-03-31 |
| TACTICATH QUARTZ SET (P130026/S018) | St Jude Medical | 2016-03-31 |
| RESOLUTE MICROTRAC/RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S062) | Medtronic Vascular | 2016-03-31 |
| LIVEWIRE(R) CARDIAC ABLATION SYSTEM (P960016/S062) | St Jude Medical | 2016-03-31 |
| BLAZER OPEN-IRRIGATED ABLATION CATHETER (P150005/S002) | Boston Scientific Corp | 2016-03-30 |
| MITRACLIP DELIVERY SYSTEM (P100009/S017) | ABBOTT MEDICAL | 2016-03-30 |
| INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM (P140028/S011) | Boston Scientific Corporation | 2016-03-30 |
| CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION (P010031/S539) | Medtronic Cardiac Rhythm Disease Management | 2016-03-30 |
| VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS (P980016/S578) | Medtronic Cardiac Rhythm Disease Management | 2016-03-30 |
| IN PACT ADMIRAL PACLITAXEL-ELUTING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER (P140010/S014) | Medtronic, Inc. | 2016-03-29 |
| 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 |
| DYNAGEN CRT-D Models G150, G151, G154, G156, G158; INOGEN CRT-D (P010012/S406) | Boston Scientific Corp | 2016-03-28 |
| DYNAGEN ICD Models D150, D151, D152, D153; INOGEN ICD Models D140, (P960040/S361) | Boston Scientific | 2016-03-28 |
| CHEATHAM PLATINUM (CP) STENT SYSTEM (Covered CP Stent, Covered Mounted CP Stent, CP Stent, Mounted CP Stent) (P150028) | NuMED, Inc. | 2016-03-25 |
| MEDTRONIC COREVALVE SYSTEM (P130021/S020) | Medtronic, Inc. | 2016-03-25 |
| MELODY TRANSCATHETER PULMONARY VALVE (TPV), ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM (DS) (P140017/S002) | Medtronic, Inc. | 2016-03-25 |
| SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES (P140031/S012) | Edwards Lifesciences, LLC | 2016-03-25 |
| VASCADE VASCULAR CLOSURE SYSTEM (P120016/S017) | Cardiva Medical, Inc. | 2016-03-24 |
| GORE HELEX SEPTAL OCCLUDER (P050006/S050) | W. L. Gore & Associates, Inc. | 2016-03-24 |
| TAP SYSTEM 2A (P840002/S013) | Cardiocommand, Inc. | 2016-03-24 |
| TACTICATH QUARTZ SET (P130026/S017) | St Jude Medical | 2016-03-24 |
| THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (P060040/S053) | ABBOTT MEDICAL | 2016-03-24 |
| ORIGEN EL ICD D050, D051, D052, D053; ORIGEN MINI ICD D000, D001, D002, D003; DYNAGEN EL ICD D150, D151, D152, D15 (P960040/S366) | Boston Scientific | 2016-03-23 |
| MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWARE (P980035/S458) | Medtronic, Inc. | 2016-03-23 |
| VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS (P980016/S577) | Medtronic Cardiac Rhythm Disease Management | 2016-03-23 |
| MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEM (P010015/S295) | Medtronic, Inc. | 2016-03-23 |