| REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM MONORAIL AND OVER THE WIRE (P130030/S022) | Boston Scientific Corp | 2016-03-23 |
| REVO MRI SURESCAN IPG AND PACING SYSTEM (P090013/S219) | Medtronic, Inc. | 2016-03-23 |
| Evera S DR ICD DDBC3D1, DDBC3D4; Evera S VR ICD DVBC3D1, DVBC3D4 (P980016/S575) | Medtronic Cardiac Rhythm Disease Management | 2016-03-23 |
| DYNAGEN CRT-D G150, G151, G154; DYNAGEN X4 CRT-D G156, G158; INOGEN CRT-D G140, G141; INOGEN X4 CRT-D G146, G148 (P010012/S412) | Boston Scientific Corp | 2016-03-23 |
| CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION (P010031/S537) | Medtronic Cardiac Rhythm Disease Management | 2016-03-23 |
| PROMUS(ELEMENT PLUS/PREMIER) EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S121) | Boston Scientific Corp | 2016-03-23 |
| Brava CRT-D DTBC1D4, DTBC1D1; Brava Quad CRT-D DTBC1Q1, DTBC1QQ; Protecta CRT-D D334 TRM, Protecta CRT-D D334TRG; Protec (P010031/S536) | Medtronic Cardiac Rhythm Disease Management | 2016-03-23 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES (P130009/S051) | Edwards Lifesciences, LLC | 2016-03-22 |
| SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T) (P030011/S041) | Syncardia Systems, LLC | 2016-03-22 |
| EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESES (P860057/S145) | Edwards Lifesciences, LLC | 2016-03-22 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P110021/S056) | Edwards Lifesciences, LLC | 2016-03-22 |
| HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S073) | Medtronic | 2016-03-22 |
| SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T) (P030011/S040) | Syncardia Systems, LLC | 2016-03-22 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P100041/S069) | Edwards Lifesciences, LLC | 2016-03-22 |
| SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES (P140031/S011) | Edwards Lifesciences, LLC | 2016-03-22 |
| INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM (P140028/S008) | Boston Scientific Corporation | 2016-03-21 |
| MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEM (P010015/S293) | Medtronic, Inc. | 2016-03-21 |
| MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWARE (P980035/S456) | Medtronic, Inc. | 2016-03-21 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES (P130009/S050) | Edwards Lifesciences, LLC | 2016-03-18 |
| CAPSUREFIX MRI SURE AND SCAN LEAD (P090013/S164) | Medtronic, Inc. | 2016-03-18 |
| WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE (LAAC) DEVICE (P130013/S004) | Boston Scientific Corp | 2016-03-18 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P110021/S055) | Edwards Lifesciences, LLC | 2016-03-18 |
| SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES (P140031/S009) | Edwards Lifesciences, LLC | 2016-03-18 |
| PROMUS(ELEMENT PLUS/PREMIER) EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S120) | Boston Scientific Corp | 2016-03-18 |
| AMPLATZER MUSCULAR VSD OCCLUDER (P040040/S026) | ABBOTT MEDICAL | 2016-03-18 |
| BOSTON SCIENTIFIC EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S072) | Boston Scientific Corp | 2016-03-18 |
| SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P150003/S007) | Boston Scientific Corporation | 2016-03-18 |
| EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESES (P860057/S144) | Edwards Lifesciences, LLC | 2016-03-18 |
| REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM MONORAIL AND OVER THE WIRE (P130030/S021) | Boston Scientific Corp | 2016-03-18 |
| EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM (P090003/S039) | Boston Scientific Corporation | 2016-03-18 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P100041/S068) | Edwards Lifesciences, LLC | 2016-03-18 |
| CAPSUREFIX NOVUS, LEAD AND CAPSUREFIX , NOVUS MRI SURESCAN AND VITATRON CRYSTALLINE LEADS (P930039/S123) | Medtronic, Inc. | 2016-03-18 |
| SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T) (P030011/S042) | Syncardia Systems, LLC | 2016-03-17 |
| XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S081) | Abbott Vascular | 2016-03-17 |
| EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESES (P860057/S143) | Edwards Lifesciences, LLC | 2016-03-17 |
| CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS (P050019/S024) | Boston Scientific Corp | 2016-03-17 |
| EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM (P090003/S040) | Boston Scientific Corporation | 2016-03-17 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES (P130009/S049) | Edwards Lifesciences, LLC | 2016-03-17 |
| HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S072) | Medtronic | 2016-03-17 |
| CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION (P010031/S534) | Medtronic Cardiac Rhythm Disease Management | 2016-03-16 |
| MEDTRONIC(R) TRANSVENE LEAD SYSTEM (P920015/S174) | Medtronic, Inc. | 2016-03-16 |
| VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS (P980016/S573) | Medtronic Cardiac Rhythm Disease Management | 2016-03-16 |
| EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (P140031/S002) | Edwards Lifesciences, LLC | 2016-03-16 |
| DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (P130005/S011) | Cardiovascular Systems, Inc. | 2016-03-16 |
| CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION (P010031/S535) | Medtronic Cardiac Rhythm Disease Management | 2016-03-15 |
| VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS (P980016/S574) | Medtronic Cardiac Rhythm Disease Management | 2016-03-15 |
| ROTABLATOR(R) (P900056/S152) | Boston Scientific Corp | 2016-03-11 |
| Consulta, Syncra, Viva CRT-P (P010015/S294) | Medtronic, Inc. | 2016-03-11 |
| MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWARE (P980035/S457) | Medtronic, Inc. | 2016-03-11 |
| ARCTIC FRONT CRYOCATHETER SYSTEM (P100010/S053) | Medtronic Cryocath, LP | 2016-03-11 |
| LIFESTENT VASCULAR STENT SYSTEMS (P070014/S048) | Bard Peripheral Vascular, Inc. | 2016-03-11 |
| 7F FREEZOR CARDIAC CRYOABLATION CATHETER AND CCT.2 CRYOCONSOLE SYSTEM (P020045/S074) | Medtronic Cryocath, LP | 2016-03-11 |
| REVO MRI SURESCAN IPG AND PACING SYSTEM (P090013/S218) | Medtronic, Inc. | 2016-03-11 |
| BRAVA;BRAVA QUAD; CONCERTO II;CONSULTA;MAXIMO II;PROTECTA;PROTECTA XT;VIVA QUAD S;VIVA QUAD XT;VIVA S;VIVA XT CRT-DS (P010031/S526) | Medtronic Cardiac Rhythm Disease Management | 2016-03-10 |
| THE PERCEVAL SUTURELESS HEART VALVE (P150011/S002) | Corcym S.r.l. | 2016-03-10 |
| ATS OPEN PIVOT BILEAFLET HEART VALVE (P990046/S046) | Medtronic Ats Medical, Inc. | 2016-03-10 |
| ASTRON STENT SYSTEM (P140030/S001) | Biotronik AG | 2016-03-10 |
| THE SOLO SMART STENTLESS HEART VALVE (P130011/S003) | Corcym Canada Corp | 2016-03-10 |
| EVERA MRI; EVERA S DR;EVERA XT DR; EVERA XT VR; MAXIMO II; PROTECTA; PROTECTA XT; SECURA ICDS (P980016/S565) | Medtronic Cardiac Rhythm Disease Management | 2016-03-10 |
| LUTONIX 035 DRUG COATED BALLOON PTA CATHETER (P130024/S010) | Lutonix | 2016-03-10 |
| MYNX ACE VASCULAR CLOSURE DEVICE (MYNX ACE ) (P040044/S070) | Cordis US Corporation | 2016-03-10 |
| RESOLUTE MICROTRAC/RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S061) | Medtronic Vascular | 2016-03-09 |
| ATS OPEN PIVOT BILEAFLET HEART VALVE (P990046/S045) | Medtronic Ats Medical, Inc. | 2016-03-09 |
| Dynagen Models G150, G151, G154, G156, G158; Inogen Models G140, G141, G146, G148; Origen Models G050, G051, G056, G0 (P010012/S410) | Boston Scientific Corp | 2016-03-09 |
| Dynagen Models D150, D151, D152, D153; Inogen Models D140, D141, D142, D143; Origen Models D050, D051, D052, D053 ICD (P960040/S364) | Boston Scientific | 2016-03-09 |
| CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION (P010031/S532) | Medtronic Cardiac Rhythm Disease Management | 2016-03-08 |
| VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS (P980016/S571) | Medtronic Cardiac Rhythm Disease Management | 2016-03-08 |
| INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM (P140028/S007) | Boston Scientific Corporation | 2016-03-07 |
| MEDTRONIC COREVALVE SYSTEM (P130021/S019) | Medtronic, Inc. | 2016-03-06 |
| INTEGRITY RAPID EXCHANGE CORONARY STENT SYSTEMS (P030009/S083) | Medtronic, Ireland | 2016-03-04 |
| EPT-1000 CARDIAC ABLATION SYSTEM (P920047/S090) | Boston Scientific Corp | 2016-03-04 |
| CHILLI COOLED RF ABLATION SYSTEM (P980003/S065) | Boston Scientific Corp | 2016-03-04 |
| EPT-1000 CARDIAC ABLATION SYSTEM (P920047/S089) | Boston Scientific Corp | 2016-03-04 |
| SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P150003/S005) | Boston Scientific Corporation | 2016-03-04 |
| RX ACCULINK CAROTID STENT SYSTEM (P040012/S056) | Abbott Vascular | 2016-03-04 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S060) | Medtronic Vascular | 2016-03-04 |
| EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEM (P020025/S084) | Boston Scientific | 2016-03-04 |
| EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEM (P020025/S083) | Boston Scientific | 2016-03-04 |
| IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, NG3 EXTENDED LIFE ICD: DYNAGEN, INOGEN, ORIGEN, NG2 5 MINI ICD DYNAGEN, INOGEN, (P960040/S363) | Boston Scientific | 2016-03-03 |
| SELECTSECURE LEAD (P030036/S082) | Medtronic Cardiac Rhythm Disease Management | 2016-03-03 |
| CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR, NG3 CRT-D DYNAGEN CRT-D & X4 CRT-D, INOGEN CRT-D & X4 CRT-D. ORIGEN CRT (P010012/S409) | Boston Scientific Corp | 2016-03-03 |
| ENDURANT II & ENDURANT IIS STENT GRAFT SYSTEM, ENDURANT II AORTO-UNI-ILIAC STENT GRAFT SYSTEM (P100021/S051) | Medtronic Vascular | 2016-03-03 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S082) | W. L. Gore & Associates, Inc. | 2016-03-02 |
| ADVISA DR IPG; ADVISA DR MRI IPG (P980035/S452) | Medtronic, Inc. | 2016-03-01 |
| EVERA MRI ICD, EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD, MAXIMO 11 ICD, VIVA AF VR ICD, VISIA AF (P980016/S567) | Medtronic Cardiac Rhythm Disease Management | 2016-03-01 |
| CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P (P010015/S291) | Medtronic, Inc. | 2016-03-01 |
| REVO MRI SURESCAN IPG (P090013/S215) | Medtronic, Inc. | 2016-03-01 |
| Reply SR, Reply DR, Esprit SR, Esprit DR (P950029/S109) | MicroPort CRM USA, Inc. | 2016-03-01 |
| BRAVA CRT-D, BRAVA QUAD CRT-D, MAXIMO II CRT-D, PROTECTA CRT-D, PROCETA XT CRT-D, VIVA QUAD S CRT-D, VIVA QUARD XT CRT-D (P010031/S528) | Medtronic Cardiac Rhythm Disease Management | 2016-03-01 |
| RENO MRI SURESCAN IPG (P090013/S216) | Medtronic, Inc. | 2016-03-01 |
| ADAPTA VERSA SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, ADVISA SR MRI IPG, RELIA IPG (P980035/S454) | Medtronic, Inc. | 2016-03-01 |
| Brava CRT-D DTBC1D4, DTBC1D1; Brava Quad CRT-D DTBC1Q1, DTBC1QQ; Concerto II CRT-D D274TRK; Consulta CRT-D D204TRM, D224 (P010031/S531) | Medtronic Cardiac Rhythm Disease Management | 2016-02-29 |
| ANGIO-SEAL VASCULAR CLOSURE DEVICE (P930038/S079) | Terumo Medical Corporation | 2016-02-29 |
| SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES (P130009/S037) | Edwards Lifesciences, LLC | 2016-02-29 |
| LIVEWIRE(R) CARDIAC ABLATION SYSTEM (P960016/S061) | St Jude Medical | 2016-02-29 |
| Brava CRT-D DTBC1D4, DTBC1D1; Brava Quad CRTD DTBC1Q1, DTBC1QQ; Concerto II CRTD, D274TRK; Consulta CRT-D D204TRM, D224T (P010031/S529) | Medtronic Cardiac Rhythm Disease Management | 2016-02-29 |
| Evera MRI ICD DDMB1D4, DDMC3D4, DVMB1D4, DVMC3D4; Evera S DR ICD DDBC3D1, DDBC3D4; Evera S VR ICD DVBC3D1, DVBC3D4; Ever (P980016/S568) | Medtronic Cardiac Rhythm Disease Management | 2016-02-29 |
| IBI THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RF (P060019/S036) | Irvine Biomedical, Inc. | 2016-02-29 |
| Evera MRI ICD DDMB1D4, DDMC3D4, DVMB1D4, DVMC3D4; Evera S DR ICD DDBC3D1, DDBC3D4; Evera S VR ICD DVBC3D1, DVBC3D4; Ever (P980016/S570) | Medtronic Cardiac Rhythm Disease Management | 2016-02-29 |
| TACTICATH QUARTZ SET (P130026/S016) | St Jude Medical | 2016-02-29 |