| MEDTRONIC CARELINK HOME MONITOR MODEL 2490 (P890003/S173) | Medtronic, Inc. | 2009-09-25 |
| PASSIVE PLUS/ISOFLEX S/ISOFLEX P/ISOFELX OPTIM FAMILIES OF LEADS (P960030/S027) | ABBOTT MEDICAL | 2009-09-25 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S024) | W. L. Gore & Associates, Inc. | 2009-09-23 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S017) | W. L. Gore & Associates, Inc. | 2009-09-23 |
| RESPONSE CV CARDIOVERSION ELECTROPHYSIOLOGY CATHETER & SYSTEM ACCESSORY EQUIPMENT (P020052/S005) | St Jude Medical | 2009-09-22 |
| APEX PTCA BALLOON DILITATION CATHETER (P860019/S237) | Scimed Life Systems, Inc. | 2009-09-22 |
| RELIANCE LEADS (P910073/S079) | Boston Scientific | 2009-09-22 |
| CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS (P860057/S059) | Edwards Lifesciences, LLC | 2009-09-18 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (P020026/S067) | Cordis Corp. | 2009-09-18 |
| CONCERTO CRT-D/CONSULTA CRT-D/MAXIMO II CRT-D/CONCERTO II (P010031/S163) | Medtronic Cardiac Rhythm Disease Management | 2009-09-18 |
| VIRTUOSO/VIRTUOSO II/SECURA/MAXIMO II ICDS (P980016/S202) | Medtronic Cardiac Rhythm Disease Management | 2009-09-18 |
| STARCLOSURE SE VASCULAR CLOSURE SYSTEM (P050007/S021) | Abbott Vascular Devices | 2009-09-18 |
| RAPTORRAIL RX SDS, 2.25MM CYPHER STENT (P020026/S017) | Cordis Corp. | 2009-09-18 |
| MAVERICK2 MONORAIL (MR), MAVERICK OVER-THE-WIRE (OTW), QUANTUM MAVERICK MR AND OTW (P860019/S234) | Scimed Life Systems, Inc. | 2009-09-18 |
| TENDRIL 1888 LEADS (P960013/S050) | ABBOTT MEDICAL | 2009-09-17 |
| GORE VIABAHN ENDOPROSTHESIS (WITH HEPARIN BIOACTIVE SURFACE) (P040037/S023) | W. L. Gore & Associates, Inc. | 2009-09-17 |
| TENDRIL 1888 LEAD (P960013/S049) | ABBOTT MEDICAL | 2009-09-17 |
| ST. JUDE MEDICAL BIOCOR, BIOCOR SUPRA, EPIC AND EPIC SUPRA HEART VALVES (P040021/S010) | ABBOTT MEDICAL | 2009-09-16 |
| COGNIS PULSE GENERATOR (P010012/S218) | Boston Scientific Corp | 2009-09-16 |
| POWERLINK SYSTEM WITH INTUI TRAK DELIVERY SYSTEM (P040002/S025) | Endologix, LLC | 2009-09-16 |
| TELIGEN (P960040/S203) | Boston Scientific | 2009-09-16 |
| ENDEAVOR ZOTAROLIMUS/ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P060033/S041) | Medtronic, Inc. | 2009-09-15 |
| DRIVER & MICRO-DRIVER CORONARY STENT SYSTEMS (P030009/S035) | Medtronic, Ireland | 2009-09-15 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S066) | Cordis Corp. | 2009-09-14 |
| STARCLOSE SE VASCULAR CLOSURE SYSTEM (P050007/S020) | Abbott Vascular Devices | 2009-09-14 |
| XIENCE V AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (P070015/S014) | Abbott Vascular, Inc. | 2009-09-11 |
| APEX PTCA BALLOON DILATATION CATHETER (P860019/S238) | Scimed Life Systems, Inc. | 2009-09-08 |
| REPLY DR/SR PACEMAKERS (P950029/S045) | MicroPort CRM USA, Inc. | 2009-09-04 |
| BARD FLAIR ENDOVASCULAR STENT GRAFT (P060002/S005) | Bard Peripheral Vascular | 2009-09-04 |
| INSYNC II/III MARQUIS ICDS/INSYNC II/III PROTECT ICDS/INTRINSIC ICD (P010031/S162) | Medtronic Cardiac Rhythm Disease Management | 2009-09-03 |
| MARQUIS VR/DR ICD (P980016/S201) | Medtronic Cardiac Rhythm Disease Management | 2009-09-03 |
| ENDEAVOR/ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P060033/S039) | Medtronic, Inc. | 2009-09-03 |
| TALENT THORACIC STENT GRAFT WITH XCELERANT DELIVERY SYSTEM (P070007/S011) | Medtronic Vascular | 2009-09-01 |
| TALENT ABDOMINAL STENT GRAFT WITH XCELERANT DELIVERY SYSTEM (P070027/S010) | Medtronic Vascular | 2009-09-01 |
| BARD LIFESTENT VASCULAR STENT SYSTEM (P070014/S003) | Bard Peripheral Vascular, Inc. | 2009-09-01 |
| STARCLOSE SE VASCULAR CLOSURE SYSTEM (P050007/S019) | Abbott Vascular Devices | 2009-09-01 |
| ANEURX AAADVANTAGE STENT GRAFT DELIVERY SYSTEM (P990020/S035) | Medtronic Vascular | 2009-09-01 |
| TENDRIL ST LEAD MODEL 1882 LEADS (P960013/S048) | ABBOTT MEDICAL | 2009-08-28 |
| THERAPY CARDIAC ABLATION CATHETER (P040014/S011) | Irvine Biomedical, Inc. | 2009-08-28 |
| MITROFLOW AORTIC PERICARDIAL HEART VALVE (P060038/S004) | Corcym Canada Corp | 2009-08-28 |
| THERAPY DUAL 8/THERAPY & SAFIRE TX ABLATION CATHETERS (P040042/S016) | Irvine Biomedical,Inc.(Ibi) | 2009-08-28 |
| NC MERLIN PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER (P910031/S026) | Abbott Vascular Devices | 2009-08-26 |
| XIENCE V OTW EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P070015/S023) | Abbott Vascular, Inc. | 2009-08-26 |
| SUTURE MEDIATED CLOSURE SYSTEMS, PERCUTANEOUS VASCULAR SURGICAL SYSTEMS/ASSOCIATED ACCESSORIES (P960043/S066) | Abbott Vascular, Inc. | 2009-08-24 |
| STARCLOSE/STARCLOSE SE VASCULAR CLOSURE SYSTEMS (P050007/S018) | Abbott Vascular Devices | 2009-08-24 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S047) | W. L. Gore & Associates, Inc. | 2009-08-21 |
| CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D (P010031/S160) | Medtronic Cardiac Rhythm Disease Management | 2009-08-21 |
| VIRTUOSO II DR/VR, SECURA DR.VR, MAXIMO II DR/VR (P980016/S199) | Medtronic Cardiac Rhythm Disease Management | 2009-08-21 |
| CONFIENT SW AND LIVIAN SW (P960040/S175) | Boston Scientific | 2009-08-18 |
| LIVIAN SW (P010012/S191) | Boston Scientific Corp | 2009-08-18 |
| CARDIOCOMMAND ESOPHAGEAL BIPOLAR PACING & RECORDING CATHETERS (P860008/S019) | Cardio Command | 2009-08-18 |
| LIFEVEST WEARABLE DEFIBRILLATOR (MODELS 4000) (P010030/S011) | Zoll Manufacturing Corporation | 2009-08-17 |
| ENDEAVOR/ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S037) | Medtronic, Inc. | 2009-08-14 |
| MITROFLOW AORTIC PERICARDIAL HEART VALVE (P060038/S006) | Corcym Canada Corp | 2009-08-14 |
| FIRESTAR RX PTCA BALLOON DILATATION CATHETER AND DURASTAR RX PTCA BALLOON DILATATION CATHETER (P880003/S098) | Cordis Corp. | 2009-08-13 |
| STARCLOSE SE VASCULAR CLOSURE SYSTEM (P050007/S017) | Abbott Vascular Devices | 2009-08-13 |
| NAVISTAR THERMOCOOL CATHETER (P030031/S014) | Biosense Webster, Inc. | 2009-08-12 |
| NAVISTAR RMT CATHETERS (P990025/S017) | Biosense Webster, Inc. | 2009-08-10 |
| CELSIUS RMT AND NAVISTAR RMT CATHETERS (P950005/S025) | Biosense Webster, Inc. | 2009-08-10 |
| MYNX VASCULAR CLOSURE DEVICE (P040044/S017) | Cordis US Corporation | 2009-08-07 |
| MITROFLOW AORTIC PERICARDIAL HEART VALVE (P060038/S005) | Corcym Canada Corp | 2009-08-07 |
| GORE HELEX SEPTAL OCCLUDER (P050006/S013) | W. L. Gore & Associates, Inc. | 2009-08-07 |
| ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM (P980037/S032) | Boston Scientific Corp | 2009-08-07 |
| INSYNC CARDIAC RESYNCHRONIZATION THERAPY PACING (CRT-P) & INSYNC III CRT-P (P010015/S063) | Medtronic, Inc. | 2009-08-05 |
| MARQUIS/MAXIMO/INTRINSIC/ENTRUST/VIRTUOSO/MAXIMO II/SECURA ICD FAMILIES (P980016/S181) | Medtronic Cardiac Rhythm Disease Management | 2009-08-05 |
| PRODIGY IPG (P890003/S165) | Medtronic, Inc. | 2009-08-05 |
| KAPPA 400 DR/SR IPG (P970012/S052) | Medtronic, Inc. | 2009-08-05 |
| INSYNC FAMILIES OF ICDS/CONCERTO/MAXIMO II/CONSULTA FAMILIES OF CRT-DS (P010031/S145) | Medtronic Cardiac Rhythm Disease Management | 2009-08-05 |
| DEMA FAMILIES/C & T SERIES DEVICES (P990001/S051) | Medtronic, Inc. | 2009-08-05 |
| KAPPA 600/700/650&800/900 & SIGMA/MEDTRONIC 350/RELIA/ENPULSE II/AT500/ADAPTA/VERSA/SENSIA/ENRHYTHM FAMILIES OF IPG (P980035/S130) | Medtronic, Inc. | 2009-08-05 |
| RX ACCULINK/ACCULINK CAROTID STENT SYSTEM (P040012/S030) | Abbott Vascular | 2009-08-05 |
| MYNX VASCULAR CLOSURE DEVICE (P040044/S016) | Cordis US Corporation | 2009-08-04 |
| CONFIENT/VITALITY (P960040/S177) | Boston Scientific | 2009-07-30 |
| INSYNC II/III MARQUIS/INSYNC II PROTECT/INSYNC SENTRY/INSYNC MAXIMO/CONCERTO/MAXIMO II/CONSULTA/CONCERTO II CRT-DS (P010031/S159) | Medtronic Cardiac Rhythm Disease Management | 2009-07-30 |
| ENRHYTHM IPG (P980035/S139) | Medtronic, Inc. | 2009-07-30 |
| LIFESTENT AND LIFESTENT XL VASCULAR STENT SYSTEMS (P070014/S001) | Bard Peripheral Vascular, Inc. | 2009-07-30 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S016) | W. L. Gore & Associates, Inc. | 2009-07-30 |
| CONTAK RENEWAL FAMILY OF CRT-D (P010012/S183) | Boston Scientific Corp | 2009-07-30 |
| RENEWAL/LIVIAN (P010012/S192) | Boston Scientific Corp | 2009-07-30 |
| MARQUIS/MAXIMO/INTRINSIC/ENTRUST/VIRTUOSO/MAXIMO II/SECURA/VIRTUOSO II ICDS (P980016/S198) | Medtronic Cardiac Rhythm Disease Management | 2009-07-30 |
| CVX-3000 EXCIMER LASER CORONARY ATHRECTOMY (ELCA) SYSTEM (P910001/S032) | Spectranetics Corp. | 2009-07-29 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S030) | W. L. Gore & Associates, Inc. | 2009-07-29 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S046) | W. L. Gore & Associates, Inc. | 2009-07-29 |
| LEGEND PLUS FAMILY OF PACEMAKERS (P930022/S010) | Medtronic, Inc. | 2009-07-28 |
| MODEL 2090 MEDTRONIC CARELINK PROGRAMMER (P850051/S071) | Medtronic, Inc. | 2009-07-28 |
| LEAD END CAP KIT / LEAD ADAPTOR SLEEVE KIT / UPSIZING SLEEVE KIT (P900061/S084) | Medtronic Cardiac Rhythm Disease Management | 2009-07-28 |
| MODEL 2090 MEDTRONIC CARELINK PROGRAMMER (P010015/S070) | Medtronic, Inc. | 2009-07-28 |
| MODEL 2090 MEDTRONIC CARELINK PROGRAMMER (P010031/S158) | Medtronic Cardiac Rhythm Disease Management | 2009-07-28 |
| MODEL 2090 MEDTRONIC CARELINK PROGRAMMER (P970012/S056) | Medtronic, Inc. | 2009-07-28 |
| MODEL 2090 MEDTRONIC CARELINK PROGRAMMER (P980035/S138) | Medtronic, Inc. | 2009-07-28 |
| MODEL 2090 MEDTRONIC CARELINK PROGRAMMER (P990001/S055) | Medtronic, Inc. | 2009-07-28 |
| SPECTRANETICS LASER SHEATH (SLS) CATHETERS (P960042/S014) | Spectranetics (Philips) | 2009-07-28 |
| MODEL 2090 MEDTRONIC CARELINK PROGRAMMER (P980050/S042) | Medtronic, Inc. | 2009-07-28 |
| CAPSURE VDD LEAD (P890003/S172) | Medtronic, Inc. | 2009-07-28 |
| MULTI-LINK VISION FAMILY OF CORONARY STENT SYSTEMS (P020047/S015) | Abbott Vascular | 2009-07-28 |
| DUAL CHAMBER, IMPLANTABLE PULSE GENERATOR (P820003/S092) | Medtronic Cardiac Rhythm Disease Management | 2009-07-28 |
| MODEL 2090 MEDTRONIC CARELINK PROGRAMMER (P980016/S197) | Medtronic Cardiac Rhythm Disease Management | 2009-07-28 |
| FREESTYLE AORTIC ROOT BIOPROSTHESIS (P970031/S025) | Medtronic, Inc. | 2009-07-27 |
| STARCLOSE SE VASCULAR CLOSURE SYSTEM (P050007/S016) | Abbott Vascular Devices | 2009-07-27 |
| GORE HELEX SEPTAL OCCLUDER (P050006/S012) | W. L. Gore & Associates, Inc. | 2009-07-27 |