| ENDOTAK SQ PATCH LEAD/SQ ARRAY LEAD/SQ ARRAY XP/SMALL & LARGE PATCH LEADVENTAK NINI III/IV/ AICD PULSE GENERATORS (P910077/S100) | Boston Scientific | 2010-01-12 |
| COGNIS PULSE GENERATORS (P010012/S229) | Boston Scientific Corp | 2010-01-12 |
| CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS (P050019/S002) | Boston Scientific Corp | 2010-01-12 |
| VENTAK PRIZM VR/DR AICD PULSE GENERATOR/DR/HE/VITALITY VR AICD PULSE GENERATOR (P960040/S212) | Boston Scientific | 2010-01-12 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P860057/S064) | Edwards Lifesciences, LLC | 2010-01-12 |
| INSYNC CRT-P & INSYNC III CRT-P (P010015/S075) | Medtronic, Inc. | 2010-01-06 |
| DEMA IPG/C & T SERIES IPGS (P990001/S059) | Medtronic, Inc. | 2010-01-06 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (P020026/S072) | Cordis Corp. | 2010-01-06 |
| POWERLINK SYSTEM WITH INTUITRAK DELIVERY SYSTEM (P040002/S024) | Endologix, LLC | 2010-01-06 |
| GEM II/MARQUIS/MAXIMO/II DR/VR/INTRINSIC/ENTRUST/VIRTUOSO/II DR/VR/SECURA DR/VR ICDS (P980016/S217) | Medtronic Cardiac Rhythm Disease Management | 2010-01-06 |
| ADAPTA/SENSIA/VERSA/RELIA (P980035/S151) | Medtronic, Inc. | 2010-01-06 |
| KAPPA 600/700/650/800/900/RELIA/SIGMA/MEDTRONIC 350/ENPULSE/ENRHYTHM/AT500/ADAPTA/VERSA/SENSIA IPGS (P980035/S152) | Medtronic, Inc. | 2010-01-06 |
| KAPPA 400 DR/SR IPG (P970012/S060) | Medtronic, Inc. | 2010-01-06 |
| INSYNC/INSYNC MARQUIS II/III/INSYNC PROTECT II/III/INSYNC SENTRY & MAXIMO ICDS/CONCERTO/II/MAXIMO II/CONSULTA CRT-DS (P010031/S177) | Medtronic Cardiac Rhythm Disease Management | 2010-01-06 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS MODELS (P860057/S062) | Edwards Lifesciences, LLC | 2010-01-05 |
| CONCERTO II/MAXIMO II/CONSULTA CRT-DS (P010031/S175) | Medtronic Cardiac Rhythm Disease Management | 2009-12-30 |
| INSYNC/INSYNC II/INSYNC III MARQUIS/INSYNC II PROTECT/INSYNC SENTRY/INSYNC MAXIMO ICDS/CONCERTO & II/MAXIMO II/CONSULTA (P010031/S174) | Medtronic Cardiac Rhythm Disease Management | 2009-12-30 |
| GRUNTZIG DILACA BALLOON DILATATION CATHETERS (P790017/S102) | Medtronic, Ireland | 2009-12-30 |
| MARQUIS/MAXIMO/INTRINSIC/ENTRUST/VIRTUOSO/MAXIMO II DR/VR/VIRTUOSO II DR/VR/SECURA DR/VR ICDS (P980016/S214) | Medtronic Cardiac Rhythm Disease Management | 2009-12-30 |
| DRIVER AND MICRO-DRIVER CORONARY STENT SYSTEMS (P030009/S037) | Medtronic, Ireland | 2009-12-30 |
| CARPENTIER EDWARDS PORCINE BIOPROSTHESIS & CARPENTIER-EDWARDS BIOPROSTHETIC VALVED CONDUIT (P870056/S036) | Edwards Lifesciences, LLC | 2009-12-30 |
| MAXIMO II DR/VR/VIRTUOSO II DR/VR/SECURA DR/VR (P980016/S215) | Medtronic Cardiac Rhythm Disease Management | 2009-12-30 |
| CARPENTIER-EDWARDS DURAFLEX MITRAL LOW PRESSURE BIOPROSTHESIS (P870077/S033) | Edwards Lifesciences, LLC | 2009-12-30 |
| CARPENTIER EDWARDS S.A.V. BIOPROSTHESIS (P010041/S021) | Edwards Lifesciences, LLC | 2009-12-30 |
| EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS (P000007/S022) | Edwards Lifesciences, LLC | 2009-12-30 |
| FLEXTOME CUTTING BALLOON (P950020/S036) | Boston Scientific Corp | 2009-12-28 |
| TELIGEN ICDS (P960040/S211) | Boston Scientific | 2009-12-23 |
| CARDIOWEST TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM (P030011/S006) | Syncardia Systems, LLC | 2009-12-23 |
| CONCERTO CRT ICD/CONSULTA CRT-D/MAXIMO II CRT-D/CONCERTO II CRT-D (P010031/S173) | Medtronic Cardiac Rhythm Disease Management | 2009-12-23 |
| COGNIS CRT-DS (P010012/S228) | Boston Scientific Corp | 2009-12-23 |
| SECURA DR/VR/VIRTUOSO DR/VR ICD/MAXIMO II DR/VR/VIRTUOSO II VR/DR (P980016/S213) | Medtronic Cardiac Rhythm Disease Management | 2009-12-23 |
| COGNIS ICD (P010012/S225) | Boston Scientific Corp | 2009-12-22 |
| MEDTRONIC ATTAIN STARFIX LEAD MODEL 4195 (P060039/S008) | Medtronic, Inc. | 2009-12-22 |
| ACUITY SPIRAL LEAD DEVICE (P010012/S224) | Boston Scientific Corp | 2009-12-22 |
| PERCLOSE PROGLIDE SUTURE/PERCLOSE AT 6F SUTURE MEDIATED CLOSURE SYSTEM (P960043/S070) | Abbott Vascular, Inc. | 2009-12-22 |
| ADAPTA/VERSA/SENSIA/RELIA (P980035/S149) | Medtronic, Inc. | 2009-12-22 |
| DEMA IPG; C-SERIES IPG; T-SERIES IPG (P990001/S058) | Medtronic, Inc. | 2009-12-22 |
| TELIGEN (P960040/S209) | Boston Scientific | 2009-12-22 |
| COGNIS (P010012/S227) | Boston Scientific Corp | 2009-12-22 |
| GEM II/MARQUIS/MAXIMO/MAXIMO II DR/VR/INTRINSIC/ENTRUST/VIRTUOSO/VIRTUOSO II DR/VR/SECURA DR/VR (P980016/S212) | Medtronic Cardiac Rhythm Disease Management | 2009-12-22 |
| TELIGEN (P960040/S210) | Boston Scientific | 2009-12-22 |
| VITALITY AND CONFIENT (P960040/S207) | Boston Scientific | 2009-12-22 |
| INSYNC/INSYNC MARQUIS/II/III/INSYNC PTOTECT II/III/INSYNC SENTRY/INSYNC MAXIMO ICDS/CONCERTO/II/MAXIMO II/CONSULTA CRT-D (P010031/S172) | Medtronic Cardiac Rhythm Disease Management | 2009-12-22 |
| CONTAK RENEWAL TR (P030005/S059) | Guidant Corp. | 2009-12-22 |
| INSYNC & INSYNC III CRT-PS (P010015/S074) | Medtronic, Inc. | 2009-12-22 |
| KAPPA 600/700/650/800/900/RELIA/SIGMA/MEDTRONIC 350/ENPULSE/ENRHYTHM/AT500/ADAPTA/VERSA/SENSIA IPGS (P980035/S148) | Medtronic, Inc. | 2009-12-22 |
| LIVIAN AND CONTAK RENEWAL (P010012/S223) | Boston Scientific Corp | 2009-12-22 |
| COGNIS (P010012/S226) | Boston Scientific Corp | 2009-12-22 |
| TELIGEN FAMILY OF ICDS (P960040/S208) | Boston Scientific | 2009-12-22 |
| KAPPA 400 DR & KAPPA 400 SR IPGS (P970012/S059) | Medtronic, Inc. | 2009-12-22 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P070015/S029) | Abbott Vascular, Inc. | 2009-12-22 |
| BARD FLAIR ENDOVASCULAR STENT GRAFT (P060002/S009) | Bard Peripheral Vascular | 2009-12-18 |
| HALL EASY-FIT PROSTHETIC HEART VALVE (P790018/S051) | Medtronic Cardiac Surgery | 2009-12-18 |
| MEDTRONIC VASCULAR TALENT THORACIC STENT GRAFT SYSTEM (P070007/S014) | Medtronic Vascular | 2009-12-17 |
| VERIFLEX (LIBERTE) MONORAIL & OTW CORONARY STENT SYSTEM (P040016/S045) | Boston Scientific Scimed, Inc. | 2009-12-17 |
| MEDTRONIC VACSULAR TALENT ABDOMINAL STENT GRAFT SYSTEM (P070027/S013) | Medtronic Vascular | 2009-12-17 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT (P060008/S033) | Boston Scientific Corp | 2009-12-17 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S032) | Boston Scientific Corp | 2009-12-17 |
| PTCA CATHETERS (P860019/S246) | Scimed Life Systems, Inc. | 2009-12-17 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S018) | Zoll Manufacturing Corporation | 2009-12-17 |
| TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT (P030025/S079) | Boston Scientific Corp | 2009-12-17 |
| VERIFLEX LIBERTE MONORAIL & OTW CORONARY STENT SYSTEM (P040016/S046) | Boston Scientific Scimed, Inc. | 2009-12-17 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S015) | Zoll Manufacturing Corporation | 2009-12-16 |
| AFFINITY/INTEGRITY/VICTORY/ACCENT FAMILY OF PACEMAKERS (P880086/S182) | ABBOTT MEDICAL | 2009-12-16 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S013) | Zoll Manufacturing Corporation | 2009-12-16 |
| FRONTIER/FRONTIER II/ ANTHEM FAMILY OF CRT-PS (P030035/S063) | ABBOTT MEDICAL | 2009-12-16 |
| TALENT THORACIC STENT GRAFT SYSTEM (P070007/S015) | Medtronic Vascular | 2009-12-15 |
| TALENT ABDOMINAL STENT GRAFT SYSTEM (P070027/S014) | Medtronic Vascular | 2009-12-15 |
| ANEURX AAADVANTAGE STENT GRAFT SYSTEM (P990020/S038) | Medtronic Vascular | 2009-12-15 |
| GRUNTZIG DILACA BALLOON DILATATION CATHETERS (P790017/S103) | Medtronic, Ireland | 2009-12-15 |
| FLAIR ENDOVACULAR STENT GRAFT (P060002/S008) | Bard Peripheral Vascular | 2009-12-15 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S022) | W. L. Gore & Associates, Inc. | 2009-12-14 |
| TELIGEN PACEMAKER (P960040/S206) | Boston Scientific | 2009-12-14 |
| OVATIO VR AND OVATIO DR ICDS (P980049/S051) | MicroPort CRM USA, Inc. | 2009-12-14 |
| NAVISTAR (4MM, DS, THERMOCOOL AND RMT) (P010068/S018) | Biosense Webster, Inc. | 2009-12-14 |
| NAVISTAR (4MM, DS, THERMOCOOL AND RMT) (P040036/S014) | Biosense Webster, Inc. | 2009-12-14 |
| NAVISTAR THERMOCOOL AND NAVISTAR RMT THERMOCOOL CATHETERS (P990025/S022) | Biosense Webster, Inc. | 2009-12-14 |
| ELA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (P060027/S016) | MicroPort CRM USA, Inc. | 2009-12-14 |
| COGNIS PACEMAKER (P010012/S222) | Boston Scientific Corp | 2009-12-14 |
| EZ STEER NAV AND EZ STEER NAV DS CATHETERS (P030031/S021) | Biosense Webster, Inc. | 2009-12-14 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESES HEART VALVES (P860057/S055) | Edwards Lifesciences, LLC | 2009-12-11 |
| MYNX VASCULAR CLOSURE DEVICE (P040044/S021) | Cordis US Corporation | 2009-12-11 |
| DURASTAR/FIRESTAR RX PTCA DILATATION CATHETERS (P880003/S099) | Cordis Corp. | 2009-12-11 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS MODELS (P860057/S053) | Edwards Lifesciences, LLC | 2009-12-08 |
| LIFESTENT AND LIFESYENT XL VASCULAR STENT SYSTEMS (P070014/S006) | Bard Peripheral Vascular, Inc. | 2009-12-08 |
| INSYNC/INSYNC III CRT-PS (P010015/S071) | Medtronic, Inc. | 2009-12-07 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S030) | Boston Scientific Corp | 2009-12-07 |
| XIENCE V AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (P070015/S022) | Abbott Vascular, Inc. | 2009-12-07 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S031) | Boston Scientific Corp | 2009-12-07 |
| TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S075) | Boston Scientific Corp | 2009-12-07 |
| TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S076) | Boston Scientific Corp | 2009-12-07 |
| NAVISTAR RMT THERMOCOOL CATHETER (P030031/S019) | Biosense Webster, Inc. | 2009-12-07 |
| TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S077) | Boston Scientific Corp | 2009-12-07 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S043) | Boston Scientific Scimed, Inc. | 2009-12-07 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S044) | Boston Scientific Scimed, Inc. | 2009-12-07 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S039) | Boston Scientific Scimed, Inc. | 2009-12-04 |
| EXPRESS SD RENAL PREMOUNTED STENT SYSTEM (P060006/S001) | Boston Scientific Corp | 2009-12-04 |
| TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S066) | Boston Scientific Corp | 2009-12-04 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S025) | Boston Scientific Corp | 2009-12-04 |
| PTCA CATHETERS (P860019/S244) | Scimed Life Systems, Inc. | 2009-12-04 |