| VENTAK AV AICD SYSTEM (P960040/S148) | Boston Scientific | 2007-12-20 |
| CONTAK RENEWAL TR CRT-P SYSTEM (P030005/S046) | Guidant Corp. | 2007-12-20 |
| CONTAK CD/EASYTRACK CRT SYSTEM (P010012/S155) | Boston Scientific Corp | 2007-12-20 |
| NEXSTENT CAROTID STENT & MONORAIL DELIVERY SYSTEM (P050025/S007) | Boston Scientific | 2007-12-20 |
| VENTAK MINI AICD SYSTEM (P910077/S076) | Boston Scientific | 2007-12-20 |
| DELTA/VISTA AND VIGOR (P840068/S046) | Boston Scientific | 2007-12-20 |
| PULSAR/PULSAR MAX/ DISCOVERY/MERIDIAN (P940031/S061) | Boston Scientific | 2007-12-20 |
| SAFIRE BIDIRECTIONAL ABLATION CATHETER (P960016/S020) | St Jude Medical | 2007-12-19 |
| EPIC HF FAMILY CRT-D'S (P030054/S073) | ABBOTT MEDICAL | 2007-12-19 |
| RIATA FAMILY OF LEADS (P950022/S048) | ABBOTT MEDICAL | 2007-12-19 |
| CADENCE FAMILY ICD'S (P910023/S161) | ABBOTT MEDICAL | 2007-12-19 |
| RELIANCE FAMILY OF LEADS (P910073/S068) | Boston Scientific | 2007-12-19 |
| CONCERTO (P010031/S086) | Medtronic Cardiac Rhythm Disease Management | 2007-12-18 |
| RIATA FAMILY OF LEADS (P950022/S047) | ABBOTT MEDICAL | 2007-12-18 |
| ENTRUST & VIRTUOSO (P980016/S116) | Medtronic Cardiac Rhythm Disease Management | 2007-12-18 |
| ENRHYTHM (P980035/S082) | Medtronic, Inc. | 2007-12-18 |
| TENDRIL FAMILY OF LEADS (P960013/S036) | ABBOTT MEDICAL | 2007-12-18 |
| MYNX VASCULAR CLOSURE DEVICE (P040044/S004) | Cordis US Corporation | 2007-12-17 |
| AFFINITY/INTEGRITY/VICTORY/ZEPHYR FAMILY OF PACEMAKERS (P880086/S158) | ABBOTT MEDICAL | 2007-12-14 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S047) | Cordis Corp. | 2007-12-13 |
| CYPHER SIROLIMUS ELUTING CORONARY STENT (P020026/S045) | Cordis Corp. | 2007-12-13 |
| CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS (P870077/S025) | Edwards Lifesciences, LLC | 2007-12-13 |
| CARPENTIER-EDWARDS SUPRA-ANNULAR (S.A.V.) BIOPROSTHESIS (P010041/S014) | Edwards Lifesciences, LLC | 2007-12-13 |
| CARPENTIER-EDWARDS BIOPROSTHESIS (P870056/S027) | Edwards Lifesciences, LLC | 2007-12-13 |
| EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS (P000007/S013) | Edwards Lifesciences, LLC | 2007-12-13 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P860057/S044) | Edwards Lifesciences, LLC | 2007-12-13 |
| MICRONY FAMILY OF PACEMAKERS (P970013/S022) | ABBOTT MEDICAL | 2007-12-12 |
| AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS (P880086/S156) | ABBOTT MEDICAL | 2007-12-12 |
| CADENCE FAMILY OF ICDS (P910023/S162) | ABBOTT MEDICAL | 2007-12-12 |
| SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS (P880006/S055) | St. Jude Medical, Inc. | 2007-12-12 |
| MOSAIC PORCINE BIOPROSTHESIS, MODELS 305, 310 (P990064/S022) | Medtronic, Inc. | 2007-12-12 |
| EPIC HF/ATLAS + HF FAMILY OF CRT-DS (P030054/S074) | ABBOTT MEDICAL | 2007-12-12 |
| HANCOCK II PORCINE BIOPROSTHESIS, MODELS T505 AND T510 (P980043/S015) | Medtronic, Inc. | 2007-12-12 |
| FRONTIER/FRONTIER II FAMILY OF CRT-PS (P030035/S037) | ABBOTT MEDICAL | 2007-12-12 |
| PRODIGY/THERA I IPG (P890003/S132) | Medtronic, Inc. | 2007-12-11 |
| VARIOUS FAMILIES OF PACEMAKERS (P980035/S083) | Medtronic, Inc. | 2007-12-11 |
| INSYNC FAMILIES OF ICD & CONCERTO ICD (P010031/S087) | Medtronic Cardiac Rhythm Disease Management | 2007-12-11 |
| FRONTIER/FRONTIER II FAMILY OF CRT-PS (P030035/S038) | ABBOTT MEDICAL | 2007-12-11 |
| AFFINITY/INTEGRITY/VICTORY/ZEPHYR FAMILY OF PACEMAKERS (P880086/S157) | ABBOTT MEDICAL | 2007-12-11 |
| GRUNTZIG DILACA CORONARY ARTERY BALLOON DILATION CATHETER (P790017/S093) | Medtronic, Ireland | 2007-12-11 |
| VARIOUS FAMILIES OF ICDS (P980016/S117) | Medtronic Cardiac Rhythm Disease Management | 2007-12-11 |
| OPEN PIVOT BI-LEAFLET MECHANICAL HEART VALVE (P990046/S016) | Medtronic Ats Medical, Inc. | 2007-12-11 |
| KAPPA 400 DR & SR PACEMAKERS (P970012/S032) | Medtronic, Inc. | 2007-12-11 |
| IPULSE CIRCULATORY SUPPORT SYSTEM (P900023/S047) | Abiomed Cardiovascular, Inc. | 2007-12-11 |
| INSYNC CRT-P & INSYNC III CRT-P (P010015/S036) | Medtronic, Inc. | 2007-12-11 |
| KRONOS LV-T CRT-D & LUMAX VR/DR/HF (-T) ICDS & CDT-DS (P050023/S006) | Biotronik, Inc. | 2007-12-07 |
| LEXOS DR/VR(-T) ICDS & LUMOS VR/DR (-T) & XELOS DR-T ICD & BELOS DR (-T) ICDS (P000009/S022) | Biotronik, Inc. | 2007-12-07 |
| ICS 3000 IMPLANT CONTROL SYSTEM (P950037/S055) | Biotronik, Inc. | 2007-12-07 |
| CARDIAC AIRBAG (-T) ICDS & BELOS VR (-T) ICDS & TMS 1000 PLUS PROGRAMMING SYSTEM (P980023/S029) | Biotronik, Inc. | 2007-12-07 |
| CADENCE TIERED-THERAPY DEFIBRILLATOR SYSTEM (P910023/S160) | ABBOTT MEDICAL | 2007-12-07 |
| CYLOS PACEMAKER & PHILOS II PACEMAKERS & ICS 3000 IMPLANT CONTROL SYSTEM & IMPLANT MODULE (P950037/S053) | Biotronik, Inc. | 2007-12-07 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S006) | W. L. Gore & Associates, Inc. | 2007-12-06 |
| GORE HELEX SEPTAL OCCLUDER (P050006/S005) | W. L. Gore & Associates, Inc. | 2007-12-06 |
| ANEURX AAADVANTAGE XCELERANT HYDRO DELIVERY SYSTEM (P990020/S028) | Medtronic Vascular | 2007-12-06 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S008) | W. L. Gore & Associates, Inc. | 2007-12-06 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S032) | W. L. Gore & Associates, Inc. | 2007-12-06 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S020) | W. L. Gore & Associates, Inc. | 2007-12-06 |
| PRIZM/VITALITY (P960040/S154) | Boston Scientific | 2007-12-05 |
| CONTRAK RENEWAL TR (P030005/S048) | Guidant Corp. | 2007-12-05 |
| AMPLATZER MUSCULAR VSD OCCLUDER (P040040/S001) | ABBOTT MEDICAL | 2007-12-05 |
| VIGOR DR/SR/DISCOVER/MERIDIAN/PDP (P940031/S062) | Boston Scientific | 2007-12-05 |
| VENTAK MINI & CONTAK RENEWAL 3 (P910077/S081) | Boston Scientific | 2007-12-05 |
| CONTAK RENEWAL/VITALITY (P010012/S163) | Boston Scientific Corp | 2007-12-05 |
| INSYNC II MARQUIS (P010031/S085) | Medtronic Cardiac Rhythm Disease Management | 2007-12-04 |
| ENRHYTHM P1501 DR (P980035/S081) | Medtronic, Inc. | 2007-12-04 |
| AMPLATZER DUCT OCCLUDER (P020024/S017) | ABBOTT MEDICAL | 2007-12-04 |
| AMPLATZER SEPTAL OCCLUDER AND AMPLATZER MULTIFENESTRATED SEPTAL OCCLUDER-CRIBRIFORM (P000039/S023) | ABBOTT MEDICAL | 2007-12-04 |
| MEDTRONIC ICD'S (P980016/S115) | Medtronic Cardiac Rhythm Disease Management | 2007-12-04 |
| PRECISE NITINOL STENT SYSTEM & PRECISE RX NITINOL STENT SYSTEM & PRECISE PRO RX NITINOL STENT SYSTEM (P030047/S008) | Cordis US Corporation | 2007-11-30 |
| CARBOMEDICS PROSTHETIC HEART VALVE (CPHV) (P900060/S039) | Corcym S.r.l. | 2007-11-30 |
| MULTI-LINK RX ULTRA CORONARY STENT SYSTEM (P970020/S051) | Abbott Vascular, Inc. | 2007-11-30 |
| SMART NITINOL SYSTEM & SMART CONTROL NITINOL STENT SYSTEM (P020036/S009) | Cordis US Corporation | 2007-11-30 |
| PTCA DILATATION CATHETERS (P880003/S093) | Cordis Corp. | 2007-11-30 |
| ANGIO-SEAL VASCULAR CLOSURE DEVICE (P930038/S051) | Terumo Medical Corporation | 2007-11-29 |
| FREESTYLE AORTIC ROOT BIOPROSTHESIS (P970031/S019) | Medtronic, Inc. | 2007-11-29 |
| MOSAIC PORCINE BIOPROSTHESIS (P990064/S019) | Medtronic, Inc. | 2007-11-29 |
| NAVISTAR THERMOCOOL CATHETER FOR TREATMENT OF TYPE I ATRIAL FLUTTER (P030031/S006) | Biosense Webster, Inc. | 2007-11-28 |
| DRIVER & MICRO-DRIVER CORONARY STENT SYSTEMS (P030009/S016) | Medtronic, Ireland | 2007-11-28 |
| CELSIUS RMT CATHETER (P950005/S022) | Biosense Webster, Inc. | 2007-11-28 |
| MOSAIC PROCINE BIOPROSTHESIS (P990064/S021) | Medtronic, Inc. | 2007-11-21 |
| HANCOCK MODIFIED ORIFICE (MO) VALVED CONDUIT (P790007/S021) | Medtronic Heart Valves | 2007-11-21 |
| PERCUTANEOUS VASCULAR CLOSURE SURGICAL (PVS) & SUTURE MEDICATED CLOSURE (SMC) SYSTEM (P960043/S062) | Abbott Vascular, Inc. | 2007-11-21 |
| FREESTYLE AORTIC ROOT BIOPROSTHESIS (P970031/S022) | Medtronic, Inc. | 2007-11-21 |
| ST JUDE MEDICAL MECHANICAL HEART VALVE (P810002/S060) | ABBOTT MEDICAL | 2007-11-21 |
| CONTAK CD/EASYTRAK DEVICES (P010012/S161) | Boston Scientific Corp | 2007-11-21 |
| VENTAK AV/VR (VENTAK PRIZM) DEVICES (P960040/S152) | Boston Scientific | 2007-11-21 |
| PERCUTANEOUS VASCULAR CLOSURE SURGICAL (PVS) & SUTURE MEDICATED CLOSURE (SMC) SYSTEMS (P960043/S061) | Abbott Vascular, Inc. | 2007-11-21 |
| EASYTRACK 2 FAMILY OF LEADS (P010012/S158) | Boston Scientific Corp | 2007-11-21 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S038) | Cordis Corp. | 2007-11-21 |
| HANCOCK II PORCINE BIOPROSTHESIS (P980043/S014) | Medtronic, Inc. | 2007-11-21 |
| VARIOUS FAMILIES OF PACEMAKERS (P990001/S034) | Medtronic, Inc. | 2007-11-16 |
| GEM III AT ICD (P980050/S031) | Medtronic, Inc. | 2007-11-16 |
| KAPPA 400 DR IPG AND KAPPA 400 SR IPG (P970012/S031) | Medtronic, Inc. | 2007-11-16 |
| INSYNC CRT-D; CONCERTO & VARIOUS INSYNC FAMILY OF ICDS (P010031/S082) | Medtronic Cardiac Rhythm Disease Management | 2007-11-16 |
| CONCERTO (P010031/S083) | Medtronic Cardiac Rhythm Disease Management | 2007-11-16 |
| VIRTUOSO (P980016/S113) | Medtronic Cardiac Rhythm Disease Management | 2007-11-16 |
| PRODIGY/THERA-I PACEMAKERS (P890003/S130) | Medtronic, Inc. | 2007-11-16 |
| VARIOUS FAMILIES OF ICDS (P980016/S112) | Medtronic Cardiac Rhythm Disease Management | 2007-11-16 |
| VARIOUS FAMILIES OF PACEMAKERS (P980035/S080) | Medtronic, Inc. | 2007-11-16 |
| INSYNC CRT-P, INSYNC II CRT-P (P010015/S035) | Medtronic, Inc. | 2007-11-16 |