| THORATEC HEARTMATE II LVAS (P060040/S004) | ABBOTT MEDICAL | 2009-12-04 |
| EXPRESS CORONARY STENT SYSTEM (P020009/S052) | Boston Scientific Scimed, Inc. | 2009-12-04 |
| APEX MONORAIL & OTW PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) DILATATION CATHETERS (P860019/S242) | Scimed Life Systems, Inc. | 2009-12-04 |
| TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S070) | Boston Scientific Corp | 2009-12-04 |
| ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM (P980037/S033) | Boston Scientific Corp | 2009-12-04 |
| TAXUS LIBERTE PACLITTAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S021) | Boston Scientific Corp | 2009-12-04 |
| TAXUS EXPRESS 2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S072) | Boston Scientific Corp | 2009-12-03 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S042) | Boston Scientific Scimed, Inc. | 2009-12-03 |
| ANGIO-SEAL VASCULAR CLOSURE DEVICE (P930038/S060) | Terumo Medical Corporation | 2009-12-03 |
| TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S068) | Boston Scientific Corp | 2009-12-03 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S027) | Boston Scientific Corp | 2009-12-03 |
| EXPRESS 2 CORONARY STENT SYSTEM (P020009/S055) | Boston Scientific Scimed, Inc. | 2009-12-03 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S023) | Boston Scientific Corp | 2009-12-03 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S029) | Boston Scientific Corp | 2009-12-02 |
| D-STAT FLOWABLE HEMOSTAT (P990037/S029) | Vascular Solutions, Inc. | 2009-12-02 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S022) | Boston Scientific Corp | 2009-12-02 |
| TAXUS EXPRESS 2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S074) | Boston Scientific Corp | 2009-12-02 |
| FLAIR ENDOVASCULAR STENT GRAFT (P060002/S007) | Bard Peripheral Vascular | 2009-12-02 |
| EXPRESS2 CORONARY STENT SYSTEM (P020009/S053) | Boston Scientific Scimed, Inc. | 2009-12-02 |
| PTCA CATHETERS (P860019/S245) | Scimed Life Systems, Inc. | 2009-12-02 |
| TAXUS EXPRESS 2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S071) | Boston Scientific Corp | 2009-12-02 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S026) | Boston Scientific Corp | 2009-12-02 |
| EXPRESS SD RENAL PREMOUNTED STENT SYSTEM (P060006/S002) | Boston Scientific Corp | 2009-12-02 |
| EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S003) | Boston Scientific Corp | 2009-12-02 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S017) | Zoll Manufacturing Corporation | 2009-12-02 |
| EXPRESS AND EXPRESS 2 CORONARY STENT SYSTEMS (P020009/S054) | Boston Scientific Scimed, Inc. | 2009-12-02 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S040) | Boston Scientific Scimed, Inc. | 2009-12-02 |
| TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S067) | Boston Scientific Corp | 2009-12-02 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S041) | Boston Scientific Scimed, Inc. | 2009-12-02 |
| BARD LIFESTENT VASCULAR STENT SYSTEMS (P070014/S005) | Bard Peripheral Vascular, Inc. | 2009-11-27 |
| SJM ICDS (P910023/S225) | ABBOTT MEDICAL | 2009-11-27 |
| SJM CRT-DS (P030054/S140) | ABBOTT MEDICAL | 2009-11-27 |
| PTCA CATHETERS (P860019/S243) | Scimed Life Systems, Inc. | 2009-11-25 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S020) | Boston Scientific Corp | 2009-11-25 |
| NAVISTAR RMT (P990025/S021) | Biosense Webster, Inc. | 2009-11-25 |
| LATITUDE PATIENT MANAGEMENT SYSTEM (P910077/S097) | Boston Scientific | 2009-11-25 |
| NAVISTAR RMT THERMOCOOL (P030031/S018) | Biosense Webster, Inc. | 2009-11-25 |
| TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S065) | Boston Scientific Corp | 2009-11-25 |
| EXPRESS2 CORONARY STENT SYSTEM (P020009/S051) | Boston Scientific Scimed, Inc. | 2009-11-25 |
| NAVISTAR RMT DS (P010068/S017) | Biosense Webster, Inc. | 2009-11-25 |
| MYNX VASCULAR CLOSURE DEVICE (P040044/S023) | Cordis US Corporation | 2009-11-25 |
| CARPENTIER-EDWARDS BIOPROSTHESIS (P870056/S035) | Edwards Lifesciences, LLC | 2009-11-25 |
| EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS (P000007/S021) | Edwards Lifesciences, LLC | 2009-11-25 |
| CARPENTIER-EDWARDS SUPRAANNULAR (S.A.V.) BIOPROSTHESIS (P010041/S020) | Edwards Lifesciences, LLC | 2009-11-25 |
| LIBERTE CORONARY STENT SYSTEM (P040016/S038) | Boston Scientific Scimed, Inc. | 2009-11-25 |
| CELSIUS RMT (P950005/S028) | Biosense Webster, Inc. | 2009-11-25 |
| SAFIRE CARDIAC ABLATION SYSTEM (P960016/S027) | St Jude Medical | 2009-11-25 |
| NAVISTAR RMT THERMOCOOL (P040036/S013) | Biosense Webster, Inc. | 2009-11-25 |
| MYNX VASCULAR CLOSURE DEVICE (P040044/S022) | Cordis US Corporation | 2009-11-25 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S014) | Zoll Manufacturing Corporation | 2009-11-25 |
| CARPENTIER-EDWARDS PERIMOUNT PERCARDIAL BIOPROSTHESIS (P860057/S061) | Edwards Lifesciences, LLC | 2009-11-25 |
| CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL (P870077/S032) | Edwards Lifesciences, LLC | 2009-11-25 |
| SAFIRE CARDIAC ABLATION SYSTEM (P960016/S026) | St Jude Medical | 2009-11-25 |
| MULTI-LINK VISION FAMILY OF CORONARY STENT SYSTEMS (P020047/S016) | Abbott Vascular | 2009-11-24 |
| NAVISTAR AND CELSIUS THERMOCOOL CATHETERS (P030031/S020) | Biosense Webster, Inc. | 2009-11-24 |
| MYNX VASCULAR CLOSURE DEVICE (P040044/S020) | Cordis US Corporation | 2009-11-20 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S018) | W. L. Gore & Associates, Inc. | 2009-11-20 |
| SAFIRE CARDIAC ABLATION SYSTEM (P960016/S025) | St Jude Medical | 2009-11-20 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S032) | W. L. Gore & Associates, Inc. | 2009-11-20 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S025) | W. L. Gore & Associates, Inc. | 2009-11-20 |
| TALENT THORACIC STENT GRAFT SYSTEM (P070007/S010) | Medtronic Vascular | 2009-11-20 |
| TENDRIL LEADS (P960013/S053) | ABBOTT MEDICAL | 2009-11-20 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S048) | W. L. Gore & Associates, Inc. | 2009-11-20 |
| GORE HELEX SEPTAL OCCLUDER (P050006/S015) | W. L. Gore & Associates, Inc. | 2009-11-20 |
| SJM ACTIVE & PASSIVE LEADS (P960030/S015) | ABBOTT MEDICAL | 2009-11-19 |
| SJM ACTIVE & PASSIVE LEADS (P960013/S028) | ABBOTT MEDICAL | 2009-11-19 |
| PERCLOSE PROGLIDE SUTURE-MEDIATED CLOSURE SYSTEM & PERCLOSE A T 6F SUTURE-MEDIATED CLOSURE SYSTEM (P960043/S069) | Abbott Vascular, Inc. | 2009-11-18 |
| EPIC HF/ATLAS + HF CRT-DS (P030054/S138) | ABBOTT MEDICAL | 2009-11-18 |
| TALENT ABDOMINAL STENT GRAFT SYSTEM (P070027/S009) | Medtronic Vascular | 2009-11-18 |
| CADENCE ICDS (P910023/S222) | ABBOTT MEDICAL | 2009-11-18 |
| MODEL 6476 G2 RF LATITUDE COMMUNICATOR (P910077/S098) | Boston Scientific | 2009-11-16 |
| CONTAK RENEWAL/VITALITY (P010012/S213) | Boston Scientific Corp | 2009-11-16 |
| VIGOR DR/SR/DISCOVER/MERIDIAN/PDP (P940031/S065) | Boston Scientific | 2009-11-16 |
| CONTAK RENEWAL TR (P030005/S058) | Guidant Corp. | 2009-11-16 |
| XACT CAROTID STENT SYSTEM (P040038/S020) | Abbott Vascular, Inc. | 2009-11-16 |
| PRIZM/VITALITY (P960040/S199) | Boston Scientific | 2009-11-16 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P070015/S027) | Abbott Vascular, Inc. | 2009-11-16 |
| CADENCE ICD SYSTEM (P910023/S216) | ABBOTT MEDICAL | 2009-11-13 |
| EPIC HF CRT-D SYSTEM (P030054/S133) | ABBOTT MEDICAL | 2009-11-13 |
| STARCLOSE SE VASCULAR CLOSURE SYSTEM (P050007/S015) | Abbott Vascular Devices | 2009-11-13 |
| ENDEAVOR ZOTAROLIMUS & SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S033) | Medtronic, Inc. | 2009-11-13 |
| DRIVER CORONARY STENT SYSTEMS (P030009/S036) | Medtronic, Ireland | 2009-11-12 |
| GRUNTZIG DILACA BALLOON DILATATION CATHETERS (P790017/S101) | Medtronic, Ireland | 2009-11-12 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S029) | W. L. Gore & Associates, Inc. | 2009-11-12 |
| ENDEAVOR & ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P060033/S044) | Medtronic, Inc. | 2009-11-12 |
| CARDIAC RESYNCHRONIZATION HE DEFIBRILLATOR (P010012/S217) | Boston Scientific Corp | 2009-11-10 |
| TALENT THORACIC STENT GRAFT SYSTEM (P070007/S013) | Medtronic Vascular | 2009-11-10 |
| COGNIS/TELIGEN (P960040/S202) | Boston Scientific | 2009-11-10 |
| XACT CAROTID STENT SYSTEM (P040038/S019) | Abbott Vascular, Inc. | 2009-11-06 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESES (P860057/S060) | Edwards Lifesciences, LLC | 2009-11-06 |
| CAPSURE FIX LEADS (P930039/S034) | Medtronic, Inc. | 2009-11-05 |
| INSYNC & INSYNC III CRT-P (P010015/S047) | Medtronic, Inc. | 2009-11-05 |
| VARIOUS FAMILY OF PACEMAKERS (P980035/S106) | Medtronic, Inc. | 2009-11-05 |
| KAPPA 400 DR IPG & SR IPG PACEMAKERS (P970012/S037) | Medtronic, Inc. | 2009-11-05 |
| INSYNC CRT-P & INSYNC III CRT-P (P010015/S046) | Medtronic, Inc. | 2009-11-05 |
| INSYNC CRT-D & CONCERTO/CONSULTA CRT-D/MAXIMO II CRT-D & VARIOUS INSYNC FAMILES ODF ICDS (P010031/S113) | Medtronic Cardiac Rhythm Disease Management | 2009-11-05 |
| CAPSURE LEADS (P890003/S176) | Medtronic, Inc. | 2009-11-05 |
| VARIOUS FAMILIES OF PACEMAKERS (P980035/S103) | Medtronic, Inc. | 2009-11-05 |
| VARIOUS FAMILIES OF ICDS (P980016/S138) | Medtronic Cardiac Rhythm Disease Management | 2009-11-05 |
| PRODIGY/THERA I IPG (P890003/S144) | Medtronic, Inc. | 2009-11-05 |