| S.M.A.R.T. AND S.M.A.R.T. CONTROL NITINOL STENT SYSTEM (P020036/S033) | Cordis US Corporation | 2015-11-25 |
| CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P (P010015/S286) | Medtronic, Inc. | 2015-11-25 |
| PRECISE, PRECISE RX AND PRECISE PRO RX NITINOL STENT SYSTEM (P030047/S029) | Cordis US Corporation | 2015-11-25 |
| MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUISI II DR/VR ICD (P980016/S559) | Medtronic Cardiac Rhythm Disease Management | 2015-11-25 |
| ADVISA DR IPG, ADVISA DR MRI IPG, ADVISA SR MRI IPG (P980035/S445) | Medtronic, Inc. | 2015-11-25 |
| S.M.A.R.T. AND S.M.A.R.T. CONTROL VASCULAR STENT SYSTEM (P120002/S009) | Cordis US Corporation | 2015-11-25 |
| CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECT XT CRT-D (P010031/S519) | Medtronic Cardiac Rhythm Disease Management | 2015-11-25 |
| LUTONIX 035 DRUG COATED BALLOON PTA CATHETER (P130024/S008) | Lutonix | 2015-11-24 |
| MITROFLOW AORTIC PERICARDIAL HEART VALVE (MAPHV) (P060038/S024) | Corcym Canada Corp | 2015-11-24 |
| ENDURANT STENT GRAFT SYSTEM, ENDURANT II STENT GRAFT SYSTEM, ENDURANT II AORTO-UNI-LLIAC (AUI) STENT GRAFT SYSTEM (P100021/S050) | Medtronic Vascular | 2015-11-24 |
| IN.PACT ADMIRAL PACLITAXEL-COATED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER (P140010/S011) | Medtronic, Inc. | 2015-11-23 |
| LUTONIX DRUG COATED BALLOON (P130024/S003) | Lutonix | 2015-11-23 |
| HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S067) | Medtronic | 2015-11-20 |
| LUTONIX 035 DRUG COATED BALLOON PTA CATHETER (P130024/S005) | Lutonix | 2015-11-20 |
| DYNAGEN CRT-D & X4 CRT-D, INOGEN CRT-D & X4 CRT-D, ORIGEN CRT-D & X4 CRT-D (P010012/S403) | Boston Scientific Corp | 2015-11-19 |
| EMBLEM S-ICD SYSTEM (P110042/S055) | Boston Scientific Corporation | 2015-11-19 |
| TACTICATH QUARTZ SET (P130026/S009) | St Jude Medical | 2015-11-19 |
| ORIGEN EL, INOGEN EL, DYNAGEN EL ICD'S ; ORIGEN MINI, INOGEN MINI, DYNAGEN MINI ICD'S (P960040/S358) | Boston Scientific | 2015-11-19 |
| INGENIO 2 CRT-P, VALITUDE & VALTITUDE X4 CRT-PS (P030005/S130) | Guidant Corp. | 2015-11-19 |
| ALTRUA 2, ESSENTIO, PROPONENT, ACCOLADE PACEMAKERS (N970003/S183) | Boston Scientific Corp | 2015-11-19 |
| SPRINT QUATTRO LEAD (P920015/S167) | Medtronic, Inc. | 2015-11-18 |
| SELECTSECURE LEAD (P030036/S080) | Medtronic Cardiac Rhythm Disease Management | 2015-11-18 |
| MITRACLIP CLIP DELIVERY SYSTEM AND MITRACLIP STEERABLE GUIDE CATHETER (P100009/S010) | ABBOTT MEDICAL | 2015-11-18 |
| CAPSUREFIX LEAD (P930039/S143) | Medtronic, Inc. | 2015-11-18 |
| AFX ENDOVASCULAR AAA STENT SYSTEM (P040002/S056) | Endologix, LLC | 2015-11-18 |
| CAPSUREFIX MRI LEAD (P090013/S208) | Medtronic, Inc. | 2015-11-18 |
| RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM (P110038/S010) | Bolton Medical, Inc. | 2015-11-18 |
| LIVEWIRE TC CARDIAC ABLATION SYSTEM (P960016/S058) | St Jude Medical | 2015-11-17 |
| INNOVA (TM) VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM (P140028/S005) | Boston Scientific Corporation | 2015-11-16 |
| IMPELLA 2.5 SYSTEM (P140003/S001) | Abiomed, Inc. | 2015-11-13 |
| FREEZOR CARDIAC CRYOBLATION CATHETER, FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE, FREEZOR MAX SURGICAL CARDIAC CR (P020045/S068) | Medtronic Cryocath, LP | 2015-11-12 |
| ADVISA DR IPG, ADVISA DR MRI IPG, ADVISA SR MRI IPG (P980035/S444) | Medtronic, Inc. | 2015-11-12 |
| CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D; PROTECTA CRT-D, PROTECTA XT CRT-D, (P010031/S518) | Medtronic Cardiac Rhythm Disease Management | 2015-11-12 |
| FREEZOR MAX CARDIAC CRYOBLATION CATHETER; ARCTIC FRONT CARDIAC CRYOBLATION CATHETER; ARCTIC FRONT ADVANCE CARDIAC CRYOBL (P100010/S051) | Medtronic Cryocath, LP | 2015-11-12 |
| MAXIMO II ICD, PROTECTA ICD, PROTECTA XI ICD, SECURA ICD, VIRTUOSO II DR/VR ICD (P980016/S557) | Medtronic Cardiac Rhythm Disease Management | 2015-11-12 |
| CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P (P010015/S284) | Medtronic, Inc. | 2015-11-12 |
| MEDTRONIC COREVALVE AND COREVALVE EVOLUT R SYSTEMS (P130021/S016) | Medtronic, Inc. | 2015-11-10 |
| INNOVA (TM) VASCULAR SELF EXPANDING STENT WITH DELIVERY SYSTEM (P140028/S004) | Boston Scientific Corporation | 2015-11-09 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S063) | Zoll Manufacturing Corporation | 2015-11-06 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S054) | Zoll Manufacturing Corporation | 2015-11-06 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S053) | Zoll Manufacturing Corporation | 2015-11-06 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S059) | Zoll Manufacturing Corporation | 2015-11-06 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S064) | Zoll Manufacturing Corporation | 2015-11-06 |
| ENDO RELIANCE/ S/G/SG/DF4 DEFIBRILLATION LEADS (P910073/S122) | Boston Scientific | 2015-11-06 |
| THERMOCOOL SMARTTOUCH (P040036/S053) | Biosense Webster, Inc. | 2015-11-05 |
| CELSIUS DS (P950005/S059) | Biosense Webster, Inc. | 2015-11-05 |
| CORDIS S.M.A.R.T. AND S.M.A.R.T. CONTROL VASCULAR STENT SYSTEM (P120002/S011) | Cordis US Corporation | 2015-11-05 |
| NAVISTAR (P990025/S047) | Biosense Webster, Inc. | 2015-11-05 |
| CELSIUS THERMOCOOL, THERMOCOOL SF, NAVISTAR THERMOCOOL, THERMOCOOL SF NAV, THERMOCOOL SMARTTOUCH (P030031/S071) | Biosense Webster, Inc. | 2015-11-05 |
| CELSIUS, CELSIUS FLTR, NAVISTAR DS (P010068/S049) | Biosense Webster, Inc. | 2015-11-05 |
| CORDIS S.M.A.R.T. CONTROL NITINOL STENT SYSTEM (P020036/S035) | Cordis US Corporation | 2015-11-05 |
| MY CARE-LINK SMART MONITOR PATIENT READER (P890003/S340) | Medtronic, Inc. | 2015-11-04 |
| HANCOCK LOW POROSITY VALVED CONDUIT (P870078/S030) | Medtronic, Inc. | 2015-11-04 |
| MOSAIC PORCINE BIOPROSTHESIS (P990064/S061) | Medtronic, Inc. | 2015-11-04 |
| EMBLEM S-ICD PULSE GENERATOR (P110042/S053) | Boston Scientific Corporation | 2015-11-04 |
| HANCOCK MODIFIED ORIFICE VALUED CONDUIT (P790007/S046) | Medtronic Heart Valves | 2015-11-04 |
| HANCOCK II PORCINE BIOPROSTHESIS (P980043/S052) | Medtronic, Inc. | 2015-11-04 |
| FREESTYLE AORTIC ROOT BIOPROSTHESIS (P970031/S051) | Medtronic, Inc. | 2015-11-04 |
| IMPELLA 2.5 SYSTEM (P140003/S006) | Abiomed, Inc. | 2015-11-03 |
| ALTRUA 2, ESSENTIO, PROPONENT, ACCOLADE PACEMAKERS (N970003/S182) | Boston Scientific Corp | 2015-11-03 |
| THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) (P060040/S045) | ABBOTT MEDICAL | 2015-11-03 |
| VALITUDE (MODEL U125), VALITUDE X4 (MODEL U128) CRT-PS (P030005/S129) | Guidant Corp. | 2015-11-03 |
| SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (P030011/S034) | Syncardia Systems, LLC | 2015-11-02 |
| ANGIOJET ULTRA THROMBECTOMY SYSTEM CONSOLE (P980037/S050) | Boston Scientific Corp | 2015-11-02 |
| VALIANT THORACIC STENT GRAFT WITH THE CAPTIVIA DELIVERY SYSTEM (P100040/S021) | Medtronic Vascular | 2015-10-30 |
| CAPSUREFIX LEAD (P930039/S141) | Medtronic, Inc. | 2015-10-30 |
| SPRINT QUATTRO LEAD (P920015/S165) | Medtronic, Inc. | 2015-10-30 |
| ANGIOJET ULTRA XMI, SPIROFLEX, SPIROFLEX VG, DISTAFLEX THROMBECTOMY SETS (P980037/S049) | Boston Scientific Corp | 2015-10-30 |
| 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 (P010031/S511) | Medtronic Cardiac Rhythm Disease Management | 2015-10-29 |
| PROTEGO DF-1 LEAD FAMILY (P980023/S070) | Biotronik, Inc. | 2015-10-29 |
| EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD (P980016/S548) | Medtronic Cardiac Rhythm Disease Management | 2015-10-29 |
| MITRACLIP CLIP DELIVERY SYSTEM (P100009/S014) | ABBOTT MEDICAL | 2015-10-29 |
| SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM (P030011/S035) | Syncardia Systems, LLC | 2015-10-29 |
| 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, EVERA MRI ICD (P010031/S516) | Medtronic Cardiac Rhythm Disease Management | 2015-10-29 |
| EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD (P980016/S554) | Medtronic Cardiac Rhythm Disease Management | 2015-10-29 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL AORTIC BIO (P860057/S139) | Edwards Lifesciences, LLC | 2015-10-27 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (P130009/S041) | Edwards Lifesciences, LLC | 2015-10-27 |
| ZILVER PTX DRUG-ELUTING PERIPHERAL STENT (P100022/S016) | Cook Ireland, Ltd. | 2015-10-26 |
| BRAVA CRT-D, CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D, VIVA QUAD S CRT-D, (P010031/S515) | Medtronic Cardiac Rhythm Disease Management | 2015-10-23 |
| REVO MRI SURESCAN IPG (P090013/S203) | Medtronic, Inc. | 2015-10-23 |
| TALENT OCCLUDER WITH OCCLUDER DELIVERY SYSTEM (P070027/S046) | Medtronic Vascular | 2015-10-23 |
| ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, ADVISA SR MRI IPG (P980035/S440) | Medtronic, Inc. | 2015-10-23 |
| EVERA MRI ICD,EVERA S DR ICD,EVERA S VR ICD,EVERA XT DR ICD,EVERA XT ICD,MAXIMO II ICD, PROTECTA ICD, PROTECT XT ICD,SEC (P980016/S552) | Medtronic Cardiac Rhythm Disease Management | 2015-10-23 |
| EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S070) | Boston Scientific Corp | 2015-10-23 |
| INNOVA (TM) VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM (P140028/S003) | Boston Scientific Corporation | 2015-10-23 |
| SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM (P030011/S033) | Syncardia Systems, LLC | 2015-10-22 |
| CONSULTA CRT-P, SYNCRA CTR-P (P010015/S282) | Medtronic, Inc. | 2015-10-22 |
| BRAVA CRT-D,BRAVA QUARD CRT-D,CONCERTO II CRT-D, CONSULTA CRT-D,MAXIMOII CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D, VIVA (P010031/S514) | Medtronic Cardiac Rhythm Disease Management | 2015-10-22 |
| XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S078) | Abbott Vascular | 2015-10-22 |
| REVO MRI SURESCAN IPG (P090013/S204) | Medtronic, Inc. | 2015-10-22 |
| XIENCE V AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S131) | Abbott Vascular, Inc. | 2015-10-22 |
| XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM, LL, XIENCE (P110019/S079) | Abbott Vascular | 2015-10-22 |
| EVERA MRI ICD, EVERA S DR ICD, EVERA XT DR ICD, EVERA XT VR ICD, MAXIMO II ICD, PROTECTS ICD, PROTECTS XT ICD, SECURA IC (P980016/S553) | Medtronic Cardiac Rhythm Disease Management | 2015-10-22 |
| ADAPTA, VERSA, SENSIA IPG, ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, ADVISA SR MRI IPG, RELIA IPG (P980035/S441) | Medtronic, Inc. | 2015-10-22 |
| MULTI-LINK VISION MULTI-LINK MINI-VISION AND MULTI-LINK 8 (P020047/S063) | Abbott Vascular | 2015-10-22 |
| THERAPY COOL PATH, SAFIRE BLU, SAFIRE BLU SP, AND THERAPY COOL PATH SP ABLATION CATHETERS (P060019/S034) | Irvine Biomedical, Inc. | 2015-10-21 |
| GEN 2 S-ICD & SQ-RX PULSE GENERATOR, SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFRILLATOR (P110042/S052) | Boston Scientific Corporation | 2015-10-21 |
| TACTICATH QUARTZ CATHETER AND TACTISYSQUARTZ EQUIPMENT (P130026/S010) | St Jude Medical | 2015-10-21 |
| FLEXABILITY ABLATION CATHETER, THERAPY COOL PATH DUO, SAFIRE BLU DUO, COOL PATH DUO, SAFIRE DUO, THERAPY COOL PATH DUO (P110016/S023) | ABBOTT MEDICAL | 2015-10-21 |
| LIVEWIRE TC STEERABLE ELECTROPHYSIOLOGY CATHETER, SAFIRE BI-DIRECTIONAL ABLATION CATHETER (P960016/S057) | St Jude Medical | 2015-10-21 |