| ION PACLITAXEL ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S117) | Boston Scientific Corp | 2015-06-23 |
| CAPSUREFIX NOVUS MRI SURESCAN LEAD MODEL 5076 (P930039/S130) | Medtronic, Inc. | 2015-06-22 |
| ADVISA SR IPG (P980035/S424) | Medtronic, Inc. | 2015-06-22 |
| DYNAGEN, INOGEN, ORIGEN, PUNCTUA, ENERGEN, INCEPTA ICD'S (P010012/S389) | Boston Scientific Corp | 2015-06-22 |
| ENTOVIS DR, ENTOVIS DR-T, ENTOVIS SR, ENTOVIS SR-T, EVIA DR, EVIA DR-T, EVIA SR,EVIA SR-T, ESTELLA DR, ESTELLA DR-T, EST (P950037/S155) | Biotronik, Inc. | 2015-06-22 |
| DYNAGEN, INOGEN, ORIGEN, PUNCTUA, ENERGEN, INCEPTA CRT-D (P960040/S347) | Boston Scientific | 2015-06-22 |
| COREVALVE (TM) EVOLUT(TM) R SYSTEM (P130021/S014) | Medtronic, Inc. | 2015-06-22 |
| ELUNA 8 HF-T,ETRINSA 8 HF-T, EPYRA 8 HF-T,EVIA HF-T,STRATOS LV,COROX OTW 75-BP,COROX OTW 85BP,COROX OTW-S 75-BP,COROX OT (P070008/S066) | Biotronik, Inc. | 2015-06-22 |
| IPERIA 7 VR-T (DF-1),IPERIA 7 VR-T (DF-4),ITREVIA 7 VR-T (DF-1),ITREVIA 7 VR-T (DF-4),INVENTRA 7 VR-T (DF-1),INVENTRA 7 (P050023/S092) | Biotronik, Inc. | 2015-06-22 |
| LINOX SMART SD 60/16,LINOX SMART SD 65/16,LINOX SMART SD 65/18,LINOX SMART SD 75/18,LINOX SMART TD 65/16,LINOX SMART TD (P980023/S068) | Biotronik, Inc. | 2015-06-22 |
| INVENTRA CRT-D (P050023/S085) | Biotronik, Inc. | 2015-06-19 |
| ON-X PROSTHETIC HEART VALVE (P000037/S041) | On-X Life Technologies, Inc. | 2015-06-19 |
| IN PACT ADMIRAL PACLITAXEL-COATING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER (P140010/S002) | Medtronic, Inc. | 2015-06-19 |
| PHYLAX AV ICD SYSTEM (P000009/S062) | Biotronik, Inc. | 2015-06-19 |
| STRATOS LV/LV-T CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRP-T) SYSTME (P070008/S062) | Biotronik, Inc. | 2015-06-19 |
| DROMOS DRISK RATE ADAPTIVE PACEING SYSTEM (P950037/S150) | Biotronik, Inc. | 2015-06-19 |
| ROTAWIRE ELITE GUIDEWIRE (P900056/S145) | Boston Scientific Corp | 2015-06-19 |
| IN.PACT ADMIRAL PACLITAXEL-COATING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER (P140010/S003) | Medtronic, Inc. | 2015-06-19 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (P130009/S036) | Edwards Lifesciences, LLC | 2015-06-18 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTH (P860057/S137) | Edwards Lifesciences, LLC | 2015-06-18 |
| EDWARDS EXPANDABLE INTRODUCER SHEATH SET (P130009/S035) | Edwards Lifesciences, LLC | 2015-06-17 |
| IMPELLA 2.5 SYSTEM (P140003/S002) | Abiomed, Inc. | 2015-06-17 |
| AFX ENDOVASCULAR AAA SYSTEM (P040002/S054) | Endologix, LLC | 2015-06-17 |
| SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES (P140031) | Edwards Lifesciences, LLC | 2015-06-17 |
| ADVISA DR IPG, ADVISA DR MRI IPG,AND ADVISA SR MRI IPG (P980035/S425) | Medtronic, Inc. | 2015-06-16 |
| SMARTABLATE SYSTEM (P990071/S031) | Biosense Webster, Inc. | 2015-06-16 |
| ANGIO-SEAL VASCULAR CLOSURE DEVICE (P930038/S074) | Terumo Medical Corporation | 2015-06-16 |
| CAPSUREFIX LEAD (P930039/S132) | Medtronic, Inc. | 2015-06-16 |
| REVO MRI SURESCAN IPG (P090013/S187) | Medtronic, Inc. | 2015-06-16 |
| CONSULTA CRT-P, SYNCRA CRT-P AND VIVA CRT-P (P010015/S273) | Medtronic, Inc. | 2015-06-16 |
| RESQCPR SYSTEM (P110024/S001) | ZOLL Medical Corporation | 2015-06-15 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S051) | Medtronic Vascular | 2015-06-12 |
| INTELLATIP MIFI XP TEMPERATURE ABLATION CATHETER (P020025/S072) | Boston Scientific | 2015-06-12 |
| INTEGRITY CORONARY STENT SYSTEMS (P030009/S081) | Medtronic, Ireland | 2015-06-12 |
| EVIA HF, EVIA HF-T, ENTOVIS HF, ENTOVIS HF-T (P070008/S065) | Biotronik, Inc. | 2015-06-12 |
| ROTOBLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S147) | Boston Scientific Corp | 2015-06-12 |
| LINOX SMART SD 60/16,LINOX SMART SD 65/16,LINOX SMART SD 65/18,LINOX SMART SD 75/18,LINOX SMART TD 65/16, LINOX SMART TD (P980023/S067) | Biotronik, Inc. | 2015-06-12 |
| ILESTO 7 HF-T, ILESTO 5 HF-T, IFORIA 7 HF-T IFORIA 5 HF-T, INVENTRA 7 HF-T (DF-1), INVENTRA 7 HF-T (DF4), IPERIA 7HF-T ( (P050023/S091) | Biotronik, Inc. | 2015-06-12 |
| EVIA DR, EVIA DR-T, EVIA SR, EVIA SR-T, ENTOVIS DR, ENTOVIS DR-T, ENTOVIS SR, ENTOVIS SR-T, ESTELLA DR, ESTELLA DR-T, ES (P950037/S154) | Biotronik, Inc. | 2015-06-12 |
| CARPENTIER-EDWARDS PERIMOUNT AORTIC & MITRAL BIOPROSTHESIS FAMILIES (P860057/S135) | Edwards Lifesciences, LLC | 2015-06-11 |
| GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P130006/S019) | W. L. Gore & Associates, Inc. | 2015-06-11 |
| GORE HELEX SEPTAL OCCLUDER, GORE CARDIOFORM SEPTAL OCCLUDER (P050006/S047) | W. L. Gore & Associates, Inc. | 2015-06-11 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S080) | W. L. Gore & Associates, Inc. | 2015-06-11 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S044) | W. L. Gore & Associates, Inc. | 2015-06-11 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S116) | W. L. Gore & Associates, Inc. | 2015-06-11 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S074) | W. L. Gore & Associates, Inc. | 2015-06-11 |
| ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S116) | Boston Scientific Corp | 2015-06-11 |
| PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S107) | Boston Scientific Corp | 2015-06-11 |
| SUPERA PERIPHERAL STENT SYSTEM (P120020/S010) | Abbott Vascular (Idef Technologies Inc) | 2015-06-10 |
| HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM (P100047/S053) | Medtronic | 2015-06-09 |
| ZILVER PTX DRUG-ELUTING PERIPHERAL STENT (P100022/S013) | Cook Ireland, Ltd. | 2015-06-08 |
| CAPSUREFIX NOVUS LEAD, CAPSUREFIX NOVUS LEAD AND CAPSUREFIX NOVUS MRI SURESCAN LEAD, VITATRON CRYSTALLINE ACTIVE FIXATIO (P930039/S131) | Medtronic, Inc. | 2015-06-06 |
| ACTIVITRAX II IPG, ACTIVITRAX IPG, LEGEND II IPG,LEGEND IPG,MICRO MINIX,MINIX,MINIXST IPGS,PREMIER IPG,PREVAIL IPG, VITA (P850051/S083) | Medtronic, Inc. | 2015-06-04 |
| MEDTRONIC PCD, TACHYARRHYTHMIA CONTROL SYSTEM (P920015/S152) | Medtronic, Inc. | 2015-06-04 |
| APPLICATION SOFTWARE, MEDTRONIC GEM ICD, MEDTRONIC JEWEL ICD, MEDTRONIC JEWEL PLUS ICD, MEDTRONIC MICRO JEWEL ICD,MEDTRO (P900061/S134) | Medtronic Cardiac Rhythm Disease Management | 2015-06-04 |
| APPLICATION SOFTWARE AND JEWEL AF ICD (P980050/S099) | Medtronic, Inc. | 2015-06-04 |
| APPLICATION SOFTWARE, CONSULTA CRT-P, INSYNC IPG, SYNCRA CRT-P AND VIVA CRT-P (P010015/S271) | Medtronic, Inc. | 2015-06-04 |
| LEGEND PLUS IPG (P930022/S018) | Medtronic, Inc. | 2015-06-04 |
| APPLICATION SOFTWARE, EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD,EVERA XT VR ICD,GEM DR ICD,GEM II DR ICD,GEM I (P980016/S537) | Medtronic Cardiac Rhythm Disease Management | 2015-06-04 |
| APPLICATION SOFTWARE, PROVIT SOFTWARE, VITATRON C20 SR IPG, VITATRON C60 DR IPG, VITATRON T20 SR IPG, VITATRON T60 DR (P990001/S120) | Medtronic, Inc. | 2015-06-04 |
| APPLICATION SOFTWARE, BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO ICD, CONCERTO II CRT-D, CONSULTA CRT-D, INSYNC ICD, INSYNC (P010031/S500) | Medtronic Cardiac Rhythm Disease Management | 2015-06-04 |
| ORIGEN EL ICD, ORIGEN MINI ICD, DYNAGEN EL ICD, DYNAGEN MINI ICD, INOGEN EL ICD, INOGEN MINI ICD, INCEPTA ICD, ENERGEN I (P960040/S346) | Boston Scientific | 2015-06-04 |
| THORATEC HEARTMATE II VENTRICULAR ASSIST SYSTEM (P060040/S042) | ABBOTT MEDICAL | 2015-06-04 |
| APPLICATION SOFTWARE, KAPPA 400 DR IPG AND KAPPA 400 SR IPG (P970012/S097) | Medtronic, Inc. | 2015-06-04 |
| THORATEC VENTRICULAR ASSIST DEVICE SYSTEM (P870072/S060) | Thoratec Laboratories Corp. | 2015-06-04 |
| ANGIO-SEAL VASCULAR CLOSURE DEVICE (P930038/S076) | Terumo Medical Corporation | 2015-06-04 |
| ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, ADVISA SR MRI IPG, APPLICATION SOFTWARE,AT500 DDDRP PACING (P980035/S421) | Medtronic, Inc. | 2015-06-04 |
| SYMBIOS IPG AND SYNERGYST IPG (P820003/S134) | Medtronic Cardiac Rhythm Disease Management | 2015-06-04 |
| DYNAGEN CRT-D, DYNAGEN X4 CRT-D,INOGEN CRT-D, INOGEN X4 CRT-D,ORIGEN CRT-D, ORIGEN X4 CRT-D, INCEPTA TM ICD,ENERGEN TM I (P010012/S388) | Boston Scientific Corp | 2015-06-04 |
| APPLICATION SOFTWARE, REVO MRI IPG AND SOFTWARE (P090013/S184) | Medtronic, Inc. | 2015-06-04 |
| CARELINK® MONITOR (P890003/S330) | Medtronic, Inc. | 2015-06-04 |
| THORATEC HEARTMATE II LVAS (P060040/S041) | ABBOTT MEDICAL | 2015-06-03 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S043) | W. L. Gore & Associates, Inc. | 2015-06-03 |
| CATHETER, PERCUTANEOUS, CARDIAC ABLATION CELSIUS THERMO-COOL ELECTROPHYSIOLOGY CATHETER (P030031/S068) | Biosense Webster, Inc. | 2015-06-02 |
| CATHETER, PERCUTANEOUS, CARDIAC ABLATION NAVISTAR ELECTROPHYSIOLOGY CATHETER (P990025/S046) | Biosense Webster, Inc. | 2015-06-02 |
| GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P130006/S018) | W. L. Gore & Associates, Inc. | 2015-06-02 |
| PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM-OTW (P110010/S105) | Boston Scientific Corp | 2015-06-02 |
| CATHETER, PERCUTANEOUS, CARDIAC ABLATION CELSIUS ELECTROPHYSIOLOGY CATHETER, (P950005/S057) | Biosense Webster, Inc. | 2015-06-02 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S079) | W. L. Gore & Associates, Inc. | 2015-06-02 |
| CATHETER, PERCUTANEOUS, CARDIAC ABLATION NAVISTAR DS ELECTROPHYSIOLOGY CATHETER (P010068/S047) | Biosense Webster, Inc. | 2015-06-02 |
| PROMUS ELEMENT PLUS AND PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMINUM CORONARY STENT SYSTEM (MONORAIL & OVER-THE- (P110010/S096) | Boston Scientific Corp | 2015-06-01 |
| WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE TECHNOLOGY (P130013/S002) | Boston Scientific Corp | 2015-06-01 |
| IMPLANTABLE PULSE GENERATOR (PG), ESSENTIO, PROPONENT, ACCOLADE, ALTRUA2 (N970003/S176) | Boston Scientific Corp | 2015-05-31 |
| CARDIAC RESYNCHRONIZATION THERAPY -PACEMAKER (CRT P) VALITUDE: U125 AND U128 (P030005/S123) | Guidant Corp. | 2015-05-31 |
| BLAZER II TEMPERATURE ABLATION CATHETER, BLAZER II HTD TEMPERATURE ABLATION CATHETER (P920047/S080) | Boston Scientific Corp | 2015-05-29 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S061) | Zoll Manufacturing Corporation | 2015-05-29 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S115) | Boston Scientific Corp | 2015-05-28 |
| CORDIS SMART AND SMART CONTROL VASCULAR STENT SYSTEMS (P120002/S010) | Cordis US Corporation | 2015-05-28 |
| REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE) (P130030/S012) | Boston Scientific Corp | 2015-05-28 |
| ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM GUIDEWIRE (P900056/S146) | Boston Scientific Corp | 2015-05-28 |
| CORDIS SMART AND SMART CONTROL NITINOL STENT SYSTEMS VARIOUS (P020036/S034) | Cordis US Corporation | 2015-05-28 |
| BLAZER II XP CARDIAC ABLATION CATHETER AND CABLE (P020025/S071) | Boston Scientific | 2015-05-28 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING STENT SYSTEM/PROMUS PREMIER EVEROLIMUS-ELUTING CHROMIUM CORONARY STENT SYSTEM (P110010/S106) | Boston Scientific Corp | 2015-05-28 |
| EXPRESS SD MONORAIL PREMOUNTED STENT SYSTEM (P060006/S067) | Boston Scientific Corp | 2015-05-28 |
| CHILLI II COOLED ABLATION CATHETER AND CABLE (P980003/S059) | Boston Scientific Corp | 2015-05-28 |
| BLAZER II CARDIAC ABLATION CATHETER AND CABLE (P920047/S081) | Boston Scientific Corp | 2015-05-28 |
| CORDIS PRECISE NITINOL STENT SYSTEMS (P030047/S031) | Cordis US Corporation | 2015-05-28 |
| LUMAX DR-T, LUMAX VR-T AND LUMAX CRT-D (P050023/S086) | Biotronik, Inc. | 2015-05-27 |
| ADVISA DR IPG, ADVISA SR MRI IPG AND ADVISA DR MRI IPG (P980035/S420) | Medtronic, Inc. | 2015-05-27 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S042) | W. L. Gore & Associates, Inc. | 2015-05-27 |