| INNOVA VASCULAR SELF-EXPANDING STENT SYSTEM (P140028/S018) | Boston Scientific Corporation | 2016-09-16 |
| Evera MRI, S DR, S VR, XT DR, XT VR ICD's; Visia AM MRI VR ICD and Visia AF VR ICD (P980016/S598) | Medtronic Cardiac Rhythm Disease Management | 2016-09-15 |
| Amplia MRI & Quad CRT-D's; Brava CRT-D & Quad CRT-D's; Compia MRI CRT-D & Quad CRT-D; Viva Quad S & XT CRT-D; Viva S CR (P010031/S559) | Medtronic Cardiac Rhythm Disease Management | 2016-09-15 |
| OMNILINK ELITE VASCULAR BALLOON-EXPANDABLE STENT SYSTEM (P110043/S011) | Abbott Vascular-Cardiac Therapies | 2016-09-14 |
| MITROFLOW AORTIC PERICARDIAL HEART VALVE (P060038/S030) | Corcym Canada Corp | 2016-09-14 |
| Ingenio 2 Pacemakers, ALTURA 2, ESSENTIO, PROPONENT, ACCOLADE MODEL'S (N970003/S193) | Boston Scientific Corp | 2016-09-13 |
| Cardiac Resynchronization Therapy- Pacemaker (CRT-P); INVIVE & INTUA MODELS; Ingenio 2 CRT-P Devices VALITUDE MODEL U 12 (P030005/S141) | Guidant Corp. | 2016-09-13 |
| Ingenio 2 Pacemakers, ESSENTIO, PROPONENT, ACCOLADE MRI MODELS (P150012/S014) | Boston Scientific | 2016-09-13 |
| EMBLEM S-ICD SYSTEM & EMBLEM MRI S-ICD SYSTEM (P110042/S062) | Boston Scientific Corporation | 2016-09-13 |
| NG3 Cardiac Resynchronization Therapy-Defibrillator (CRT); DYNAGEN. INOGEN, ORIGEN CRT-D & X4 CRT-D (P010012/S431) | Boston Scientific Corp | 2016-09-13 |
| NG3 Implantable Cardioverter Defibrillator (ICD), ORIGEN, INOGEN, DYNAGEN EL ICD'S; NG2 Implantable Cardioverter Defibri (P960040/S379) | Boston Scientific | 2016-09-13 |
| Revo MRI SureScan IPG (P090013/S231) | Medtronic, Inc. | 2016-09-12 |
| Adapta/Versa/Sensia, Advisa DR/DR MRI/SR MRI, EnPulse E1/E2, Kappa DR (Kappa 700/600, 900/800)/VDD (Kappa 700) families (P980035/S471) | Medtronic, Inc. | 2016-09-12 |
| Consulta, Syncra, and Viva CRT-Ps (P010015/S305) | Medtronic, Inc. | 2016-09-12 |
| Amplia MRI/MRI Quad, Brava/Brava Quad, Compia MRI/MRI Quad, Concerto/Concert II, Consulta, Maximo II, Protecta/Protecta (P010031/S557) | Medtronic Cardiac Rhythm Disease Management | 2016-09-12 |
| Medtronic Express Monitor (P890003/S361) | Medtronic, Inc. | 2016-09-12 |
| Evera MRI/S DR/S VR/XT DR/XT VR, Intrinsic 30, Marquis VR, Maximo II, Protecta/Protecta VR/XT, Secura/Secura DR, Virtuo (P980016/S596) | Medtronic Cardiac Rhythm Disease Management | 2016-09-12 |
| ENSEMBLE II TRANSCATHETER VALVE DELIVERY SYSTEM (P140017/S004) | Medtronic, Inc. | 2016-09-12 |
| INNOVA (TM) VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM (P140028/S017) | Boston Scientific Corporation | 2016-09-12 |
| HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S081) | Medtronic | 2016-09-12 |
| PROMUS(ELEMENT PLUS/PREMIER) EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S123) | Boston Scientific Corp | 2016-09-09 |
| ELLIPSE FAMILY OF ICDS (P910023/S373) | ABBOTT MEDICAL | 2016-09-08 |
| Therapy Cool Path Ablation Catheters (P060019/S038) | Irvine Biomedical, Inc. | 2016-09-08 |
| Therapy Dual 8 Ablation Catheters (P040042/S036) | Irvine Biomedical,Inc.(Ibi) | 2016-09-08 |
| TactiCath Quartz Catheter and TactiSys Quartz Equipment (P130026/S022) | St Jude Medical | 2016-09-08 |
| SAPIEN 3 TRANSCATHETER HEART VALVE (THV), MODEL 9600TFX (P140031/S021) | Edwards Lifesciences, LLC | 2016-09-08 |
| Livewire TC Steerable Electrophysiology Catheter (P960016/S067) | St Jude Medical | 2016-09-08 |
| Therapy Ablation Catheters (P040014/S031) | Irvine Biomedical, Inc. | 2016-09-08 |
| BIOGLUE SURGICAL ADHESIVE (P010003/S025) | Cryolife, Inc. | 2016-09-08 |
| Therapy Cool Path Duo/Safire Blu Duo Ablation Catheters (P110016/S035) | ABBOTT MEDICAL | 2016-09-08 |
| Platinum VR and DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR ICD's (P980049/S119) | MicroPort CRM USA, Inc. | 2016-09-07 |
| REVO MRI SURESCAN IPG AND PACING SYSTEM RVDR01 (P090013/S221) | Medtronic, Inc. | 2016-09-07 |
| CapSureFix MRI 4076,CapSureFix Novus MRI 5076, CapSureFix MRI SureScan 5086MRI LEAD MODELS (P930039/S149) | Medtronic, Inc. | 2016-09-07 |
| ATTAIN ABILITY MRI SuresScan Lead 4196, ATTAIN ABILITY Plus MRI SureScan Lead Model 4296, ATTAIN ABILITY Straight MRI Su (P080006/S090) | Medtronic, Inc. | 2016-09-07 |
| Platinium VR 1210,1240 (ICD); Platinium DR 1510, 1540 (ICD) (P980049/S121) | MicroPort CRM USA, Inc. | 2016-09-07 |
| Capsure Sense MRI SureScan Lead Model 4074, Capsure Sense MRI SureScan Lead Model 4574 (P830061/S127) | Medtronic Cardiac Rhythm Disease Management | 2016-09-07 |
| HEARTWARE VENTRICULAR ASSIST DEVICE SYSTEM (P100047/S080) | Medtronic | 2016-09-07 |
| Advisa MRI DR & SR Surescan Implantable Pulse Generators Models A2DR01 & A3SR01 (P980035/S464) | Medtronic, Inc. | 2016-09-07 |
| Amplia MRI SureScan Model DTMB1D4, Amplia MRI Quad SureScan Model DTMB1QQ, Compia MRI SureScan Model DTMC1D4, Compia MR (P010031/S540) | Medtronic Cardiac Rhythm Disease Management | 2016-09-07 |
| Evera MRI XT DR SureScan Model DDMB1D4, Evera MRI XT VR SureScan Model DVMB1D4,Evera MRI S DR SureScan Model DDMC3D4, Ev (P980016/S579) | Medtronic Cardiac Rhythm Disease Management | 2016-09-07 |
| Sprint Quattro Secure S MRI SureScan Lead Model 6935M, Sprint Quattro Secure MRI SureScan Lead Model 6947M (P920015/S177) | Medtronic, Inc. | 2016-09-07 |
| IN PACT(TM) ADMIRAL(TM) PACLITAXEL-COATED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER (P140010/S015) | Medtronic, Inc. | 2016-09-07 |
| Platinium CRT-D 1711, 1741. (P060027/S086) | MicroPort CRM USA, Inc. | 2016-09-07 |
| Platinum CARDIAC RESYNCHRONIZATION THERAPY DEFBRILLATOR CRT's (P060027/S084) | MicroPort CRM USA, Inc. | 2016-09-07 |
| Diva family(includes Diamond II, Ruby II, Topaz II, Jade II, Vita DDDR, Vita DDD and Vita VVIR) Dema family, Selection A (P990001/S122) | Medtronic, Inc. | 2016-09-06 |
| Adapta, Advisa, AT500, EnPulse, EnRhythm, Kappa 600, 650, 700, 800, 900; Relia, Sensia, Sigma, Versa (P980035/S469) | Medtronic, Inc. | 2016-09-06 |
| MYNXGRIP VASCULAR CLOSURE DEVICE (5F, 6F/7F) (P040044/S068) | Cordis US Corporation | 2016-09-06 |
| EnTrust, Gem,Gem II, Gem III, Intrinsic, Marquis, Maximo, Maximo II, Onyx, Protecta DF4, Protecta, Protecta XT DF4 Prote (P980016/S593) | Medtronic Cardiac Rhythm Disease Management | 2016-09-06 |
| Revo MRI, EnRhythm MRI (P090013/S230) | Medtronic, Inc. | 2016-09-06 |
| SAPIEN 3 TRANSCATHETER HEART VALVE (P140031/S019) | Edwards Lifesciences, LLC | 2016-09-06 |
| Kappa 400 (P970012/S099) | Medtronic, Inc. | 2016-09-06 |
| Concerto, Right Ventricular Lead Integrity Alert, Concerto II CRT-D. Consulta CRT-D, InSync II Marquis, II Protect, III (P010031/S554) | Medtronic Cardiac Rhythm Disease Management | 2016-09-06 |
| FORTIFY ASSURA VR, FORTIFY ASSURA DR (P910023/S375) | ABBOTT MEDICAL | 2016-09-06 |
| Elite, Elite II, Minuet, Preva, Preva D, Prodigy, Synergyst II, Thera, Thera-i, Analyzer, Vitatron Legacy, Vitatron Lega (P890003/S358) | Medtronic, Inc. | 2016-09-06 |
| Consulta CRT-P, InSync, InSync III, Syncra CRT-P, Viva CRT-P (P010015/S304) | Medtronic, Inc. | 2016-09-06 |
| ANGIOSCULPT(R) PTCA SCORING BALLOON CATHETER (P050018/S022) | Spectranetics Corp. | 2016-09-06 |
| UNIFY ASSURA, QUADRA ASSURA (P030054/S307) | ABBOTT MEDICAL | 2016-09-06 |
| INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM (P140028/S016) | Boston Scientific Corporation | 2016-09-02 |
| ACUITY X4 Drug Collar Component Dwell Time (P010012/S430) | Boston Scientific Corp | 2016-09-01 |
| CapSureFix MRI Lead (P090013/S233) | Medtronic, Inc. | 2016-09-01 |
| LIFEVEST WEARABLE DEFIBRILLATOR (WCD) 3000, 4000 (P010030/S080) | Zoll Manufacturing Corporation | 2016-09-01 |
| Adapta, Versa, Sensia IPG ADDR01, ADDR03, ADDR06, ADDRL1, ADDRS1, SEDR01, SESR01, VEDR01, ADD01, SEDRL1, SED01, SES01, A (P980035/S473) | Medtronic, Inc. | 2016-09-01 |
| CapSureFix Novus Lead (P930039/S155) | Medtronic, Inc. | 2016-09-01 |
| HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM (P100047/S079) | Medtronic | 2016-09-01 |
| ELCA CORONARY ATHERECTOMY CATHETERS (P910001/S079) | Spectranetics Corp. | 2016-08-31 |
| FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE (P020045/S073) | Medtronic Cryocath, LP | 2016-08-31 |
| BARD LIFESTENT VASCULAR STENT SYSTEM (P070014/S051) | Bard Peripheral Vascular, Inc. | 2016-08-31 |
| ARCTIC FRONT CARDIAC CRYOABLATION SYSTEM: 23MM AND 28MM ARCTIC FRONT CATHETERS, FREEZOR MAX CATHETER, CRYOCONSOLE, MANUA (P100010/S058) | Medtronic Cryocath, LP | 2016-08-31 |
| EPIC VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S037) | Boston Scientific Corp | 2016-08-30 |
| CARDIOMEMS HF SYSTEM (P100045/S010) | ABBOTT MEDICAL | 2016-08-30 |
| REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM (P130030/S028) | Boston Scientific Corp | 2016-08-30 |
| EXPRESS SD RENAL PREMOUNTED STENT SYSTEM (P060006/S078) | Boston Scientific Corp | 2016-08-30 |
| SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P150003/S019) | Boston Scientific Corporation | 2016-08-29 |
| REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM (P130030/S027) | Boston Scientific Corp | 2016-08-29 |
| PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S132) | Boston Scientific Corp | 2016-08-29 |
| MEDTRONIC COREVALVE(R) EVOLUT R SYSTEM (P130021/S022) | Medtronic, Inc. | 2016-08-26 |
| NIRxcell CoCr Cornary Stent on RX System (P110004/S020) | Medinol, Ltd. | 2016-08-25 |
| ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM (P150023/S002) | Abbott Vascular, Inc. | 2016-08-25 |
| MEDTRONIC(R) TRANSVENE LEAD SYSTEM (P920015/S175) | Medtronic, Inc. | 2016-08-24 |
| CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION (P010031/S538) | Medtronic Cardiac Rhythm Disease Management | 2016-08-24 |
| MEDTRONIC ATTAIN ABILITY MODEL 4196 LEAD (P080006/S089) | Medtronic, Inc. | 2016-08-24 |
| WALLSTENT ENDOPROSTHESIS (VENOUS) (P980033/S045) | Boston Scientific Corporation | 2016-08-24 |
| OVATION ABDOMINAL STENT GRAFT SYSTEM PLATFORM (P120006/S026) | Endologix, LLC | 2016-08-24 |
| MEDTRONIC(R) CAPSUREFIX LEAD MODEL 4068,4067,4568 (P930039/S148) | Medtronic, Inc. | 2016-08-24 |
| REVO MRI SURESCAN IPG AND PACING SYSTEM (P090013/S220) | Medtronic, Inc. | 2016-08-24 |
| WALLSTENT ILIAC ENDOPROSTHESIS (P940019/S047) | Boston Scientific Scimed, Inc. | 2016-08-24 |
| WALLSTENT ENDOPROSTHESIS (TIPS) (P930031/S056) | Boston Scientific Corp | 2016-08-24 |
| FLUENCY PLUS ENDOVASCULAR STENT GRAFT (P130029/S004) | Bard Peripheral Vascular, Inc. | 2016-08-24 |
| NIRxcell CoCr Coronary Stent on RX System (P110004/S019) | Medinol, Ltd. | 2016-08-23 |
| CARDIOGENESIS TMR LASER SYSTEM (P970029/S032) | Cryolife, Inc. | 2016-08-23 |
| EDWARDS CRIMPER (P140031/S020) | Edwards Lifesciences, LLC | 2016-08-23 |
| GORE CARDIOFORM Septal Occluder (P050006/S051) | W. L. Gore & Associates, Inc. | 2016-08-23 |
| ACUITY X4 STRAIGHT, ACUITY X4 SPIRAL S, ACUITY X4 SPIRAL L Quadripolar Coronary Venous Pace/Sense Leads (P010012/S423) | Boston Scientific Corp | 2016-08-23 |
| 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 |
| CAPSUREFIX NOVUS LEAD (P930039/S154) | Medtronic, Inc. | 2016-08-22 |
| ENDOTAK RELIANCE G/SG DEFIBRILLATION LEADS AND G/SG WITH 4-SITE CONNECTOR DEFIBRILLATION LEADS (P910073/S139) | Boston Scientific | 2016-08-22 |
| COREVALVE (TM) EVOLUTE (TM) R SYSTEM (P130021/S024) | Medtronic, Inc. | 2016-08-22 |
| VENASEAL CLOSURE SYSTEM (P140018/S003) | Medtronic Vascular, Inc. | 2016-08-21 |
| Dynagen EL & Mini, Inogen EL & Mini, Origen EL & MIni IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM (P960040/S376) | Boston Scientific | 2016-08-19 |
| Dynagen & X4, Inogen & X4, Origen & X4 CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (P010012/S427) | Boston Scientific Corp | 2016-08-19 |