| GORE VIABAHN ENDOPROSTHESIS (P040037/S092) | W. L. Gore & Associates, Inc. | 2016-06-07 |
| GORE VIABAHN ENDOPROSTHESIS AND ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P130006/S031) | W. L. Gore & Associates, Inc. | 2016-06-07 |
| DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (P130005/S013) | Cardiovascular Systems, Inc. | 2016-06-07 |
| AMPLIA MRI CRT-D, AMPLIA MRI QUAD CRT-D, COMPIA MRI CRT-D,COMPIA MRI QUAD CRT-D (P010031/S551) | Medtronic Cardiac Rhythm Disease Management | 2016-06-07 |
| EVERA MRI ICD, VISTA AF MRI VR ICD, VISIA AF VR ICD (P980016/S590) | Medtronic Cardiac Rhythm Disease Management | 2016-06-07 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S075) | Zoll Manufacturing Corporation | 2016-06-06 |
| TACTICATH QUARTZ SET (P130026/S020) | St Jude Medical | 2016-06-06 |
| ZENITH AAA ENDOVASCULAR GRAFT AND H&L-B ONE-SHOT INTRODUCTINO SYSTEM (P020018/S056) | Cook, Inc. | 2016-06-03 |
| COMPLETE SE VASCULAR STENT SYSTEM - ILLIAC (P090006/S017) | Medtronic Vascular | 2016-06-01 |
| MEDTRONIC MOSAIC PORCINE BIOPROSTHETIC HEART VALVE (P990064/S062) | Medtronic, Inc. | 2016-06-01 |
| HANCOCK II PORCINE BIOPROSTHESIS (P980043/S053) | Medtronic, Inc. | 2016-06-01 |
| INNOVA VASCULAR SELF-EXPANDING STENT SYSTEM (P140028/S014) | Boston Scientific Corporation | 2016-06-01 |
| MEDTRONIC ATTAIN ABILITY MODEL 4196,4296,4396 LEAD (P080006/S092) | Medtronic, Inc. | 2016-06-01 |
| COMPLETE SE VASCULAR STENT SYSTEM - SFA AND PPA (P110040/S009) | Medtronic Vascular | 2016-06-01 |
| SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P150003/S011) | Boston Scientific Corporation | 2016-05-31 |
| HANCOCK MODIFIED ORIFICE VALVED CONDUIT (P790007/S048) | Medtronic Heart Valves | 2016-05-31 |
| MOSAIC PORCINE BIOPROSTHETIC (P990064/S063) | Medtronic, Inc. | 2016-05-31 |
| BARD LIFESTENT VASCULAR STENT SYSTEM (P070014/S037) | Bard Peripheral Vascular, Inc. | 2016-05-31 |
| ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI Pacemakers (P150012/S002) | Boston Scientific | 2016-05-31 |
| HANCOCK LOW POROSITY VALVED CONDUIT (P870078/S032) | Medtronic, Inc. | 2016-05-31 |
| HANCOCK II PORCINE BIOPROSTHESIS (P980043/S054) | Medtronic, Inc. | 2016-05-31 |
| FREESTYLE AORTIC ROOT BIOPROSTHESIS (P970031/S052) | Medtronic, Inc. | 2016-05-31 |
| ON-X (R) PROSTHETIC HEART VALVE, MODEL ONXA (P000037/S045) | On-X Life Technologies, Inc. | 2016-05-31 |
| PROSTAR XL 10F PERCUTANEOUS VASCULAR SURGICAL SYSTEM (P960043/S092) | Abbott Vascular, Inc. | 2016-05-28 |
| TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEAD (P050023/S097) | Biotronik, Inc. | 2016-05-27 |
| INNOVA VASCULAR SELF-EXPANDING STENT SYSTEM (P140028/S013) | Boston Scientific Corporation | 2016-05-27 |
| DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS (P950037/S162) | Biotronik, Inc. | 2016-05-27 |
| OMNILINK ELITE VASCULAR BALLOON-EXPANDABLE STENT SYSTEM (P110043/S010) | Abbott Vascular-Cardiac Therapies | 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 |
| MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM (P150033/S001) | Medtronic, Inc. | 2016-05-25 |
| ADVANTIO, INGENIO, VITALIO, ESSENTIO, PROPONENT, ACCOLADE, ALTRUA 2 (N970003/S188) | Boston Scientific Corp | 2016-05-25 |
| RESOLUTE MICROTRAC/RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S068) | Medtronic Vascular | 2016-05-25 |
| ESSENTIO VALITUDE MRI, PROPONENT VALITUDE MRI, ACCOLADE VALITUDE MRI (P150012/S001) | Boston Scientific | 2016-05-25 |
| CARDIAC RESYNCHRONIZATION THERAPY- PACEMAKER (CRT-P); INVIVE AND INTUA MODELS. INGENIO 2. VALITUDE MODEL U125 ; VALITUD (P030005/S136) | Guidant Corp. | 2016-05-25 |
| NG3 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR(ICD). ORIGEN , INOGEN, DYNAGEN EL ICD'S. NG2.5 IMPLANTABLE CARDIOVERTER DEFIB (P960040/S372) | Boston Scientific | 2016-05-25 |
| VALITUDE, VALITUDE X4, INVIVE, INTUA (P030005/S135) | Guidant Corp. | 2016-05-25 |
| INGENIO 2 PACEMAKERS. ALTRUA 2 , ESSENTIO, PROPONENT, ACCOLADE. IMPLANTABLE PULSE GENERATOR (PG), ADVANTIO, INGENIO, VI (N970003/S189) | Boston Scientific Corp | 2016-05-25 |
| NG3 CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR (CRT-D). DYNAGEN CRT-D, X4 CRT-D; INOGEN CRT-D, X4 CRT-D; ORIGEN CRT (P010012/S419) | Boston Scientific Corp | 2016-05-25 |
| Evera MRI ICD DDMB1D4, DDMC3D4, DVMB1D4, DVMC3D4; Evera S DR ICD DDBC3D1, DDBC3D4; Evera S VR ICD DVBC3D1, DVBC3D4; Ever (P980016/S588) | Medtronic Cardiac Rhythm Disease Management | 2016-05-25 |
| Amplia MRI CRT-D DTMB1D4; Amplia MRI Quad CRT-D DTMB1QQ; Brava CRT-D DTBC1D4; Brava CRT-D DTBC1D1; Brava Quad CRT-D DTBC (P010031/S548) | Medtronic Cardiac Rhythm Disease Management | 2016-05-25 |
| AMPLIA MRI CRT-D; QUAD CRT-D; BRAVA CRT-D; BRAVA QUAD CRT-D; COMPIA MRI CRT-D; QUAD CRT-D; CONCERTO, CONSULTA, MAXIMO II (P010031/S549) | Medtronic Cardiac Rhythm Disease Management | 2016-05-25 |
| EVERA MRI, S DR ,S VR, XT DR , XT VR ICD'S; MAXIMO II ICD; PROTECTA ICD, PROTECTA XT ICD; SECURA ICD; VIRTUOSO II DR/VR (P980016/S589) | Medtronic Cardiac Rhythm Disease Management | 2016-05-25 |
| Rotablator Rotational Atherectomy System (ROTAWIRE GUIDEWIRE WITH WIRECLIP TORQUER) (P900056/S153) | Boston Scientific Corp | 2016-05-25 |
| PACEMAKER MODELS. ESSENTIO , PROPONENT, ACCOLADE MRI'S (P150012/S003) | Boston Scientific | 2016-05-25 |
| SYNERGYST II PULSE GENERATOR MODELS 7070 & 7071 (P890003/S352) | Medtronic, Inc. | 2016-05-24 |
| THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (P060040/S056) | ABBOTT MEDICAL | 2016-05-24 |
| VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS (P980016/S582) | Medtronic Cardiac Rhythm Disease Management | 2016-05-24 |
| Consulta CRT-P C4TR01; Syncra CRT-P C2TR01; Viva CRT-P C6TR01 (P010015/S300) | Medtronic, Inc. | 2016-05-24 |
| CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION (P010031/S542) | Medtronic Cardiac Rhythm Disease Management | 2016-05-24 |
| THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (P060040/S057) | ABBOTT MEDICAL | 2016-05-24 |
| Adapta, Versa, Sensia IPG ADDR01, ADDR03, ADDR06, ADDRL1, ADDRS1, SEDR01, SESR01, VEDR01, ADD01, SEDRL1, SED01, SES01, A (P980035/S463) | Medtronic, Inc. | 2016-05-23 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES (P130009/S058) | Edwards Lifesciences, LLC | 2016-05-23 |
| SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES (P140031/S016) | Edwards Lifesciences, LLC | 2016-05-23 |
| SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM MR & OTW (P150003/S012) | Boston Scientific Corporation | 2016-05-20 |
| PROMUS(ELEMENT PLUS/PREMIER) EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S125) | Boston Scientific Corp | 2016-05-20 |
| HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S074) | Medtronic | 2016-05-19 |
| LIVEWIRE(R) TC CARDIAC ABLATION SYSTEM (P960016/S065) | St Jude Medical | 2016-05-19 |
| SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM MR & OTW (P150003/S010) | Boston Scientific Corporation | 2016-05-18 |
| NG3 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) ORIGEN EL ICD: D050, D051, D052, D053 INOGEN EL ICD: D140, D141, D142, (P960040/S371) | Boston Scientific | 2016-05-17 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S085) | W. L. Gore & Associates, Inc. | 2016-05-17 |
| Arctic Front Advance Cardiac CryoAblation Catheters (P100010/S054) | Medtronic Cryocath, LP | 2016-05-17 |
| NG3 CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR (CRT-D) DYNAGEN CRT-D: G150, G151, G154, X4 CRT-D; G156, G158 INOGEN (P010012/S418) | Boston Scientific Corp | 2016-05-17 |
| FLAIR ENDOVASCULAR STENT GRAFT (P060002/S036) | Bard Peripheral Vascular | 2016-05-16 |
| FLUENCY PLUS ENDOVASCULAR STENT GRAFT (P130029/S001) | Bard Peripheral Vascular, Inc. | 2016-05-16 |
| CURRENT, CURRENT ACCEL, CURRENT+, ELLIPSE, FORTIFY, FORTIFY ASSURA, EPIC/EPIC+, ATLAS/II/+, FAMILY OF ICDS (P910023/S362) | ABBOTT MEDICAL | 2016-05-12 |
| ASSURITY, ASSURITY+, ENDURITY, ACCENT FAMILY PACEMAKERS (P880086/S261) | ABBOTT MEDICAL | 2016-05-12 |
| PROMOTE/+/RF/Q,PROMOTE ACCEL,PROMOTE QUADRA,UNIFY,UNIFY ASSURA,UNIFY QUADRA,QUADRA ASSURA,EPIC+/HF/HF+/IIHF/II+HF,ATLAS+ (P030054/S292) | ABBOTT MEDICAL | 2016-05-12 |
| ANGIO-SEAL VASCULAR CLOSURE DEVICE (P930038/S082) | Terumo Medical Corporation | 2016-05-12 |
| ANTHEM, ALLURE/RF, QUADRA ALLURE/RF FAMILY OF CRT-PS (P030035/S139) | ABBOTT MEDICAL | 2016-05-12 |
| PARADYM VR 8750,PARADYM DR 8750,PARADYM RF VR 9750,PARADYM RF DR 9750(ZL101),PARADYM RF VR 9750, PARADYM RF DR 9750(ZL10 (P980049/S114) | MicroPort CRM USA, Inc. | 2016-05-11 |
| INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM (P140028/S012) | Boston Scientific Corporation | 2016-05-11 |
| REPLY SR, REPLY DR, ESPRIT SR, ESPRIT DR (P950029/S108) | MicroPort CRM USA, Inc. | 2016-05-11 |
| PARADYM CRT-D 8750,PARADYM RF CRT-D 9750(ZL101),PARADYM RF CRT-D 9750(ZL102),INTENSIA CRT-D (P060027/S080) | MicroPort CRM USA, Inc. | 2016-05-11 |
| RF MARINR CATHETERS, RF ENHANCER II CATHETERS, RF CONTRACTR CATHETERS AND RF CONDUCTR CATHETERS (P930029/S052) | Medtronic, Inc. | 2016-05-11 |
| INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM (P140028/S010) | Boston Scientific Corporation | 2016-05-11 |
| REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM MONORAIL AND OVER THE WIRE (P130030/S024) | Boston Scientific Corp | 2016-05-10 |
| PROMUS(ELEMENT PLUS/PREMIER) EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S124) | Boston Scientific Corp | 2016-05-10 |
| SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P150003/S009) | Boston Scientific Corporation | 2016-05-10 |
| MITRACLIP NT CLIP DELIVERY SYSTEM (P100009/S015) | ABBOTT MEDICAL | 2016-05-10 |
| CORDIS S.M.A.R.T.AND S.M.A.R.T.CONTROL VASCULAR STENT SYSTEM (P120002/S007) | Cordis US Corporation | 2016-05-09 |
| EVERA MRI ICD, EVERA S DR ICD, EVERA S VR ICD, EVERA XT CR ICD, EVERA XT VR ICD, MAXIMO II ICD, PROTECTA ICD, PROTECTA X (P980016/S584) | Medtronic Cardiac Rhythm Disease Management | 2016-05-09 |
| AMPLIA MRI CRT-D, AMPLIA MRI QUAD CRT-D, BRAVA CRT-D, BRAVA QUAD CRT-D, COMPIA MRI CRT-D, COMPIA MRI QUAD CRT-D, CONCERT (P010031/S545) | Medtronic Cardiac Rhythm Disease Management | 2016-05-09 |
| ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, ADVISA SR MRI IPG,RELIA IPG. (P980035/S462) | Medtronic, Inc. | 2016-05-09 |
| Origen, Dynagen, Inogen EL ICD; Origen, Dynagen, Inogen MINI ICD (P960040/S369) | Boston Scientific | 2016-05-09 |
| Dynagen, Inogen, Origen CRT-D; Dynagen, Inogen, Origen X4 CRT-D (P010012/S415) | Boston Scientific Corp | 2016-05-09 |
| CONSULTA, SYNCRA, VIVA CRT-P (P010015/S299) | Medtronic, Inc. | 2016-05-09 |
| EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESES (P860057/S146) | Edwards Lifesciences, LLC | 2016-05-06 |
| ANGIO SEAL VASCULAR CLOSURE DEVICE (P930038/S081) | Terumo Medical Corporation | 2016-05-06 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES (P130009/S055) | Edwards Lifesciences, LLC | 2016-05-06 |
| SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES (P140031/S013) | Edwards Lifesciences, LLC | 2016-05-06 |
| OVATION ABDOMINAL STENT GRAFT SYSTEM (P120006/S023) | Endologix, LLC | 2016-05-05 |
| WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY (P130013/S007) | Boston Scientific Corp | 2016-05-05 |
| IN PACT ADMIRAL PACLITAXEL-ELUTING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER (P140010/S017) | Medtronic, Inc. | 2016-05-05 |
| EXCLUDER BIFURCATED ENDOPROSTHESIS (P020004/S130) | W. L. Gore & Associates, Inc. | 2016-05-05 |
| LUTONIX DRUG COATED BALLOON PTA CATHETER (P130024/S012) | Lutonix | 2016-05-05 |
| THE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEM (P000039/S055) | ABBOTT MEDICAL | 2016-05-04 |
| AMPLATZER MULTI-FENESTRATED SEPTAL OCCULDER (CRIBRIFORM) (P020024/S045) | ABBOTT MEDICAL | 2016-05-04 |
| AMPLATZER MUSCULAR VSD OCCLUDER (P040040/S028) | ABBOTT MEDICAL | 2016-05-04 |
| MELODY TRANSCATHETER PULMONARY VALVE (TPV), ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM (DS) (P140017/S003) | Medtronic, Inc. | 2016-05-04 |