| DRUG ELUTING PERMANENT RIGHT VENTRICULAR OR RIGHT ATRIAL PACEMAKER ELECTRODES, DEXTRUS, SETROX, TILDA, SAFIO (P950037/S143) | Biotronik, Inc. | 2014-11-06 |
| PARADYM RF VR 9250 PARADYM RF DR 9550 (P980049/S102) | MicroPort CRM USA, Inc. | 2014-11-06 |
| VASCADE VASCULAR CLOSURE SYSTEM (P120016/S004) | Cardiva Medical, Inc. | 2014-11-06 |
| LATITUDE CONSULT SYSTEM (P910077/S147) | Boston Scientific | 2014-11-06 |
| THE COOL POINT IRRIGATION PUMP (P060019/S029) | Irvine Biomedical, Inc. | 2014-11-06 |
| PARADYM RF CRT-D9750 (P060027/S069) | MicroPort CRM USA, Inc. | 2014-11-06 |
| ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S109) | Boston Scientific Corp | 2014-11-05 |
| PROMUS ELEMENT PLUS/ PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S098) | Boston Scientific Corp | 2014-11-05 |
| INTENSIA CRT-D (P060027/S066) | MicroPort CRM USA, Inc. | 2014-11-04 |
| ENDOTAK RELIANCE 4-SITE DEFIBRILLATION LEADS (P910073/S128) | Boston Scientific | 2014-11-04 |
| INSTENSIA ICD (P980049/S099) | MicroPort CRM USA, Inc. | 2014-11-04 |
| PROCOL VASCULAR BIOPROSTHESIS (P020049/S004) | LeMaitre Vascular, Inc. | 2014-10-31 |
| PROMUS ELEMENT PLUS/ PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S097) | Boston Scientific Corp | 2014-10-30 |
| ACE HEADER (P900061/S132) | Medtronic Cardiac Rhythm Disease Management | 2014-10-30 |
| ATTAIN PERFORMA QUADRIPOLAR LEAD (P080006/S075) | Medtronic, Inc. | 2014-10-30 |
| TUNNELING TOOL (P920015/S145) | Medtronic, Inc. | 2014-10-30 |
| REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM (P130030/S006) | Boston Scientific Corp | 2014-10-30 |
| ADAPTA, VERSA, SENSIA IPG, RELIA IPG (P980035/S397) | Medtronic, Inc. | 2014-10-30 |
| SPECTRANETICS LASER SHEATH SLS (P960042/S050) | Spectranetics (Philips) | 2014-10-30 |
| ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S108) | Boston Scientific Corp | 2014-10-30 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S108) | W. L. Gore & Associates, Inc. | 2014-10-29 |
| GORE HELEX SEPTAL OCCLUDER (P050006/S043) | W. L. Gore & Associates, Inc. | 2014-10-29 |
| AMPLATZER VSD MUSCULAR OCCLUDER (P040040/S022) | ABBOTT MEDICAL | 2014-10-29 |
| AMPLATZER SEPTAL OCCLUDER AND AMPLATZER CRIBIFORM OCCLUDER (P000039/S048) | ABBOTT MEDICAL | 2014-10-29 |
| GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P130006/S013) | W. L. Gore & Associates, Inc. | 2014-10-29 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S038) | W. L. Gore & Associates, Inc. | 2014-10-29 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S073) | W. L. Gore & Associates, Inc. | 2014-10-29 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S069) | W. L. Gore & Associates, Inc. | 2014-10-29 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S106) | W. L. Gore & Associates, Inc. | 2014-10-29 |
| DIAMONDBACK 360 CONONARY ORBITAL ATHERECTOMY SYSTEM (P130005/S001) | Cardiovascular Systems, Inc. | 2014-10-29 |
| AMPLATZER DUCT OCCLUDER (ADO) (P020024/S038) | ABBOTT MEDICAL | 2014-10-29 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S109) | W. L. Gore & Associates, Inc. | 2014-10-29 |
| CHILLI II COOLED ABLATION CATHETER (P980003/S054) | Boston Scientific Corp | 2014-10-28 |
| AORFIX AAA FLEXIBLE STENT GRAFT SYSTEM WITH AORFLEX DELIVERY DEVICE (P110032/S009) | Lombard Medical Limited | 2014-10-28 |
| DYNAGEN, INOGEN, ORIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) (P960040/S335) | Boston Scientific | 2014-10-28 |
| DYNAGEN, INOGEN, ORGEN CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) (P010012/S374) | Boston Scientific Corp | 2014-10-28 |
| ON-X PROSTHETIC HEART VALVE (P000037/S036) | On-X Life Technologies, Inc. | 2014-10-28 |
| DURATA FAMILY OF HIGH VOLTAGE LEADS (P950022/S087) | ABBOTT MEDICAL | 2014-10-27 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S072) | W. L. Gore & Associates, Inc. | 2014-10-24 |
| XIENCE V AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S126) | Abbott Vascular, Inc. | 2014-10-24 |
| XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS), XIENCE XPEDITION EVEROLIMUS ELUTING (P110019/S073) | Abbott Vascular | 2014-10-24 |
| MULTI-LINK 8 CORONARY STENT SYSTEM (P020047/S060) | Abbott Vascular | 2014-10-24 |
| GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P130006/S012) | W. L. Gore & Associates, Inc. | 2014-10-24 |
| TACTICATH QUARTZ SET (P130026) | St Jude Medical | 2014-10-24 |
| PRODIGY IPG (P890003/S324) | Medtronic, Inc. | 2014-10-23 |
| ENDURANT IIS STENT GRAFT SYSTEM (P100021/S039) | Medtronic Vascular | 2014-10-23 |
| CORDIS SMART/ SMART CONTROL NITINOL STENT SYSTEM (P020036/S030) | Cordis US Corporation | 2014-10-23 |
| VASCADE VASCULAR CLOSURE SYSTEM (P120016/S006) | Cardiva Medical, Inc. | 2014-10-23 |
| CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D (P010031/S472) | Medtronic Cardiac Rhythm Disease Management | 2014-10-23 |
| CAMERON HEALTH SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM (P110042/S041) | Boston Scientific Corporation | 2014-10-23 |
| 7F FREEZOR CARDIAC CRYOABLATION CATH.& XTRA SURGICAL DEVICE, 9F FREEZOR MAX SURGICAL CATH CATHRYOCONSOLE SYSTEM (P020045/S060) | Medtronic Cryocath, LP | 2014-10-23 |
| ADAPTA, VERSA, SENSIA IPG, RELIA IPG (P980035/S398) | Medtronic, Inc. | 2014-10-23 |
| ASCENDRA BALLOON AORTIC VALVULOPLASTY CATHETER (P110021/S046) | Edwards Lifesciences, LLC | 2014-10-23 |
| PRECISE NITINOL STENT SYSTEM (P030047/S027) | Cordis US Corporation | 2014-10-23 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (P130009/S014) | Edwards Lifesciences, LLC | 2014-10-23 |
| CORDIS SMART/SMART CONTROL VASCULAR STENT SYSTEM (P120002/S005) | Cordis US Corporation | 2014-10-23 |
| MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD (P980016/S508) | Medtronic Cardiac Rhythm Disease Management | 2014-10-23 |
| REPLY SR, REPLY DR, ESPIRIT SR, ESPRIT DR (P950029/S097) | MicroPort CRM USA, Inc. | 2014-10-23 |
| NOVAFLEX+ DELIVERY SYSTEM, ASCENDRA+ DELIVERY SYSTEM, EDWARDS EXPANDABLE INTRODUCER SHEATH SET, ASCENDRA+ INTRODUCER SHE (P130009/S013) | Edwards Lifesciences, LLC | 2014-10-23 |
| ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S107) | Boston Scientific Corp | 2014-10-22 |
| EASY TRAK 2 FAMILY (P010012/S375) | Boston Scientific Corp | 2014-10-22 |
| PROMUS ELEMENT PLUS/PREMIER EVEROLIMUS-ELUTING CHROMIUM CORONARY STENT SYSTEM (P110010/S094) | Boston Scientific Corp | 2014-10-22 |
| REBEL PLATINUM CHROMINUM CORONARY STENT SYSTEM (P130030/S005) | Boston Scientific Corp | 2014-10-22 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE NANO EECSS (P070015/S125) | Abbott Vascular, Inc. | 2014-10-22 |
| ATRICURE SYNERGY ABLATION SYSTEM (P100046/S005) | AtriCure, Inc. | 2014-10-22 |
| XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM; LL,; SV; XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTE (P110019/S072) | Abbott Vascular | 2014-10-22 |
| ZENITH (FLEX) AAA ENDOVASCULAR GRAFT, ZENITH RENU AAA ANCILLARY GRAFT, ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT (P020018/S053) | Cook, Inc. | 2014-10-21 |
| ENTOVIS, EVIA, ESTELLA, EFFECTA, ECURO, DEXTRUS, SETROX, SELOX, TILDA, P-KIT, SAFIO, SLX, CARDIOMESSENGER LLT KIT, ICS (P950037/S141) | Biotronik, Inc. | 2014-10-21 |
| BLAZER II, BLAZER II HTD, BLAZER PRIME HTD (P920047/S074) | Boston Scientific Corp | 2014-10-21 |
| ALTRUA 2, ESSENTIO, PROPONENT AND ACCOLADE (N970003/S167) | Boston Scientific Corp | 2014-10-21 |
| CAPSURE Z NOVUS LEAD; VITATRON IMPULSE II LEAD (P850089/S112) | Medtronic Cardiac Rhythm Disease Management | 2014-10-21 |
| NAVI-STAR RMT DS ELECTROPHYSIOLOGY CATHETER (P010068/S042) | Biosense Webster, Inc. | 2014-10-21 |
| EVIA HF-T, ENTOVIS HF-T, STRATOS LV, COROX OTW, CELERITY 2D,LV-KIT (P070008/S056) | Biotronik, Inc. | 2014-10-21 |
| ICS 3000/ RENAMIC PROGRAMMERS (P000009/S059) | Biotronik, Inc. | 2014-10-21 |
| INGENIO 2 CRT-P DEVICES AND INGENIO CRT-P DEVICES (P030005/S113) | Guidant Corp. | 2014-10-21 |
| CAPSUREFIX MRI LEAD (P090013/S160) | Medtronic, Inc. | 2014-10-21 |
| CAPSUREFIX MRI LEAD (P090013/S159) | Medtronic, Inc. | 2014-10-21 |
| REBEL PTCR CORONARY STENT SYSTEM (P130030/S004) | Boston Scientific Corp | 2014-10-21 |
| NAVI-STAR RMT ELECTROPHYSIOLOGY CATHETER (P990025/S041) | Biosense Webster, Inc. | 2014-10-21 |
| ATTAIN STARFIX LEAD (P060039/S064) | Medtronic, Inc. | 2014-10-21 |
| CELSIUS ELECTROPHYSIOLOGY CATHETER (P950005/S053) | Biosense Webster, Inc. | 2014-10-21 |
| BLAZER II XP, BLAZER PRIME XP TEMPERATURE ABLATION CATHETERS (P020025/S064) | Boston Scientific | 2014-10-21 |
| SPRINT QUATTRO LEAD, SUBCUTANEOUS LEAD, TRANSVENE CS/SVC LEAD (P920015/S144) | Medtronic, Inc. | 2014-10-21 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S067) | W. L. Gore & Associates, Inc. | 2014-10-21 |
| LINOX SMART SD, VIGILA 1CR, VOLTA 1CR, LINOX SMART S DX, PROTEGO SD (P980023/S062) | Biotronik, Inc. | 2014-10-21 |
| VITATRON BRILLIANT S+VDD LEAD (P890003/S322) | Medtronic, Inc. | 2014-10-21 |
| SUREFIX LEAD (P930039/S121) | Medtronic, Inc. | 2014-10-21 |
| CAPSURE SENSE LEAD (P830061/S116) | Medtronic Cardiac Rhythm Disease Management | 2014-10-21 |
| PROMOTE, PROMOTE ACCEL, PROMOTE Q, PROMOTE QUARDA, PROMOTE RF PROMOTE+ QUADRA ASSURA, UNIFY, ASSURA, UNIFY QUADRA FAMILI (P030054/S275) | ABBOTT MEDICAL | 2014-10-21 |
| LLESTO 7 VR-T, IFORIA 7 VR-T, LLESTO 5 VR-T, IFORIA 5 VR-T, LUMAX 740 VR-T, LLESTO 7 DR-T, IFORIA 7 DR-T, LLESTO 5 DR-T (P050023/S080) | Biotronik, Inc. | 2014-10-21 |
| VITATRON EXCELLENCE PS+ LEAD (P830061/S117) | Medtronic Cardiac Rhythm Disease Management | 2014-10-21 |
| ATTAIN BIPOLAR OTW LEAD , ATTAIN OTW LEAD (P010015/S252) | Medtronic, Inc. | 2014-10-21 |
| CURRENT, CURRENT ACCEL, CURRENT+, CURRENT RF, FORTIFY, FORTIFY ASSURA FAMILIES OF ICD DEVICES (P910023/S345) | ABBOTT MEDICAL | 2014-10-21 |
| SELECT SECURE LEAD (P030036/S075) | Medtronic Cardiac Rhythm Disease Management | 2014-10-21 |
| CAPSUREFIX NOVUS LEAD (P930039/S120) | Medtronic, Inc. | 2014-10-21 |
| DYNAGEN CRT-D, INOGEN CRT-D, ORIGEN CRT-D (P010012/S373) | Boston Scientific Corp | 2014-10-20 |
| SUPERA PERIPHERAL STENT SYSTEM (SUPERB) (P120020/S002) | Abbott Vascular (Idef Technologies Inc) | 2014-10-20 |
| DYNAGEN ICD, INOGEN ICD, ORIGEN ICD (P960040/S334) | Boston Scientific | 2014-10-20 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (THV) (P130009/S012) | Edwards Lifesciences, LLC | 2014-10-20 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S044) | Medtronic Vascular | 2014-10-20 |