| KRONOS LV-T CRT-D (P050023/S012) | Biotronik, Inc. | 2008-06-02 |
| STRATOS LV/LV-T (P070008/S002) | Biotronik, Inc. | 2008-06-02 |
| ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM ROTALINK EXCHANGEABLE CATHETER (P900056/S091) | Boston Scientific Corp | 2008-05-30 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S009) | W. L. Gore & Associates, Inc. | 2008-05-29 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S010) | W. L. Gore & Associates, Inc. | 2008-05-29 |
| ANGIO-SEAL VASCULAR CLOSURE DEVICE (P930038/S055) | Terumo Medical Corporation | 2008-05-29 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENTS (P020026/S044) | Cordis Corp. | 2008-05-29 |
| ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P060033/S006) | Medtronic, Inc. | 2008-05-27 |
| CARBOMEDICS PROSTHETIC HEART VALVE (CPHV) (P900060/S040) | Corcym S.r.l. | 2008-05-27 |
| FLEXTOME CUTTING BALLOON MONORAIL (MR) AND OVER-THE-WIRE (OTW) (P950020/S027) | Boston Scientific Corp | 2008-05-27 |
| EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS, MODEL 2500P (P000007/S015) | Edwards Lifesciences, LLC | 2008-05-23 |
| NIRFLEX PREMOUNTED CORONARY STENT SYSTEM (P020040/S007) | Medinol, Ltd. | 2008-05-23 |
| CARPENTIER-EDWARDS S.A.V. BIOPROSTHESIS, MODEL 2650 (P010041/S015) | Edwards Lifesciences, LLC | 2008-05-23 |
| CARPENTIER-EDWARDS, THEON, RSR, THEON RSR, MAGNA, PLUS MITRAL, THEON MITRAL PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS (P860057/S045) | Edwards Lifesciences, LLC | 2008-05-23 |
| CARPENTIER-EDWARDS PERIMOUNT PORCINE BIOPROSTHESIS, CARPENTIER-EDWARDS PERIMOUNT PORCIN MITRAL BIOPROSTHESIS (P870056/S028) | Edwards Lifesciences, LLC | 2008-05-23 |
| CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS, MODEL 6625 LP & MODEL 6625 ESR-LP (P870077/S027) | Edwards Lifesciences, LLC | 2008-05-23 |
| EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS, MODEL 2500P (P000007/S016) | Edwards Lifesciences, LLC | 2008-05-22 |
| ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P060033/S005) | Medtronic, Inc. | 2008-05-21 |
| VITALITY HE TACHY PULSE GENERATORS (P960040/S166) | Boston Scientific | 2008-05-21 |
| DRIVER & MICRODRIVER CORONARY STENT SYSTEMS (P030009/S022) | Medtronic, Ireland | 2008-05-21 |
| CONTAK RENEWAL HEART FAILURE PULSE GENERATORS (P010012/S178) | Boston Scientific Corp | 2008-05-21 |
| ZENITH TX2 THORACIC TAA ENDOVASCULAR GRAFT WITH THE H&LB ONE-SHOT INTRODUCTION SYSTEM (P070016) | William Cook Europe Aps | 2008-05-21 |
| LIBERTE CORONARY STENT SYSTEM (P040016/S030) | Boston Scientific Scimed, Inc. | 2008-05-21 |
| TAXUS EXPRESS2 PACLITAXEL ELUTING STENT SYSTEM (P030025/S055) | Boston Scientific Corp | 2008-05-21 |
| EXPRESS2 CORONARY STENT SYSTEM (P020009/S043) | Boston Scientific Scimed, Inc. | 2008-05-21 |
| PRIZM II & VITALITY FAMILIES OF ICDS (P960040/S165) | Boston Scientific | 2008-05-19 |
| RENEWAL (P010012/S177) | Boston Scientific Corp | 2008-05-19 |
| FRONTIER/FRONTIER II CRT-P¿S AND AESCULA LEADS (P030035/S036) | ABBOTT MEDICAL | 2008-05-16 |
| PASSIVE PLUS, ISOFLEX S/P, AND ISOFLEX OPTIM LEADS (P960030/S019) | ABBOTT MEDICAL | 2008-05-16 |
| TENDRIL MODEL 1882TC LEAD (P960013/S039) | ABBOTT MEDICAL | 2008-05-16 |
| ADDVENT, AFFINITY, IDENTITY, VERITY, INTEGRITY, VICTORY, AND ZEPHYR PACEMAKERS (P880086/S155) | ABBOTT MEDICAL | 2008-05-16 |
| VARIOUS FAMILIES OF ICDS (P980016/S120) | Medtronic Cardiac Rhythm Disease Management | 2008-05-16 |
| TENDRIL, TENDRIL ST, AND OPTISENSE LEADS (P960013/S035) | ABBOTT MEDICAL | 2008-05-16 |
| SJM MECHANICAL HEART VALVE (P810002/S064) | ABBOTT MEDICAL | 2008-05-16 |
| EPIC HF CRT-D AND QUICKSITE & QUICKFLEX LEADS (P030054/S072) | ABBOTT MEDICAL | 2008-05-16 |
| ACUITY SPIRAL HEART FAILURE LEAD MODELS, 4591, 4592 AND 4593 (P010012/S160) | Boston Scientific Corp | 2008-05-16 |
| INSYNC FAMILIES OF ICD & CONCERTO ICD (P010031/S090) | Medtronic Cardiac Rhythm Disease Management | 2008-05-16 |
| REGENCY PACEMAKERS (P880006/S054) | St. Jude Medical, Inc. | 2008-05-16 |
| ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S003) | Medtronic, Inc. | 2008-05-16 |
| CADENCE ICDS (P910023/S159) | ABBOTT MEDICAL | 2008-05-16 |
| MICRONY PACEMAKERS (P970013/S021) | ABBOTT MEDICAL | 2008-05-16 |
| ENRHYTHM IPG (P980035/S085) | Medtronic, Inc. | 2008-05-16 |
| RIATA, RIATA ST, AND DURATA LEADS (P950022/S045) | ABBOTT MEDICAL | 2008-05-16 |
| MYNX VASCULAR CLOSURE DEVICE (P040044/S005) | Cordis US Corporation | 2008-05-16 |
| OVATIO CRT SYSTEM (P060027) | MicroPort CRM USA, Inc. | 2008-05-15 |
| EPIC HF/ATLAS + HF CRT-DS (P030054/S087) | ABBOTT MEDICAL | 2008-05-15 |
| CADENCE ICDS (P910023/S174) | ABBOTT MEDICAL | 2008-05-15 |
| ATTAIN CS & ATTAIN OTW & ATTAIN BIPOLAR OTW (P010015/S043) | Medtronic, Inc. | 2008-05-14 |
| VARIOUS FAMILIES OF LEADS (P920015/S044) | Medtronic, Inc. | 2008-05-14 |
| CAPSURE FIX (P980016/S129) | Medtronic Cardiac Rhythm Disease Management | 2008-05-14 |
| ATTAIN SD (P010031/S098) | Medtronic Cardiac Rhythm Disease Management | 2008-05-14 |
| CS-SVC TRANSVENE LEAD (P980050/S033) | Medtronic, Inc. | 2008-05-14 |
| CONSULTA CRT & MAXIMO II CRT (P010031/S097) | Medtronic Cardiac Rhythm Disease Management | 2008-05-14 |
| SELECTSECURE (P030036/S006) | Medtronic Cardiac Rhythm Disease Management | 2008-05-14 |
| VARIOUS FAMILIES OF ICDS (P900061/S075) | Medtronic Cardiac Rhythm Disease Management | 2008-05-14 |
| CAPSURE EPI EPICARDIAL STEROID ELUTING PACING LEAD (P950024/S010) | Medtronic, Inc. | 2008-05-14 |
| SECURA DR/VR & MAXIMO II DR/VR (P980016/S128) | Medtronic Cardiac Rhythm Disease Management | 2008-05-14 |
| IMPLANTABLE PULSE GENERATORS (P980035/S092) | Medtronic, Inc. | 2008-05-14 |
| VARIOUS FAMILIES OF PACEMAKERS (P890003/S139) | Medtronic, Inc. | 2008-05-14 |
| MEDTRONIC ADAPTA, VERSA AND SENSIA IMPLANTABLE PULSE GENERATOR AND MODEL SW003 APPLICATION SOFTWARE (P980035/S073) | Medtronic, Inc. | 2008-05-13 |
| CARELINK MONITOR MODEL 2490H (P890003/S119) | Medtronic, Inc. | 2008-05-13 |
| ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P060033/S004) | Medtronic, Inc. | 2008-05-13 |
| ON-X PROSTHETIC HEART VALVE (P000037/S013) | On-X Life Technologies, Inc. | 2008-05-12 |
| STRATOS LV CRT-P AND STRATOS LV-T CRT-P, COROX OTW BP LEAD AND COROX OTW-S BP LEAD (P070008) | Biotronik, Inc. | 2008-05-12 |
| LEGEND PLUS FAMILY OF PACEMAKERS (P930022/S006) | Medtronic, Inc. | 2008-05-09 |
| VARIOUS FAMILIES OF PACEMAKERS, CARELINK PROGRAMMER MODEL 2090 (P890003/S129) | Medtronic, Inc. | 2008-05-09 |
| ZENITH AAA ENDOVASCULAR GRAFT WITH H&L-B ONE SHOT INTRODUCTION SYSTEM (P020018/S023) | Cook, Inc. | 2008-05-09 |
| VARIOUS FAMILIES OF PACEMAKERS (P850051/S066) | Medtronic, Inc. | 2008-05-09 |
| KAPPA 400 FAMILY OF PACEMAKERS (P970012/S030) | Medtronic, Inc. | 2008-05-09 |
| JEWEL AF, GEM III FAMILY OF ICD'S (P980050/S030) | Medtronic, Inc. | 2008-05-09 |
| VARIOUS FAMILIES OF PACEMAKERS (P820003/S082) | Medtronic Cardiac Rhythm Disease Management | 2008-05-09 |
| MICRO JEWELL II ICD (P900061/S074) | Medtronic Cardiac Rhythm Disease Management | 2008-05-09 |
| VITATRON PACEMAKERS (P990001/S033) | Medtronic, Inc. | 2008-05-09 |
| INSYNC III CRT-IPG (P010015/S034) | Medtronic, Inc. | 2008-05-09 |
| VARIOUS FAMILIES OF CRT/ICD'S (P010031/S081) | Medtronic Cardiac Rhythm Disease Management | 2008-05-09 |
| KAPPA 700/600 SIGMA AND ENRYTHM IPG'S (P980035/S079) | Medtronic, Inc. | 2008-05-09 |
| ZOOM LATITUDE PROGRAMMING SYSTEM (P910077/S086) | Boston Scientific | 2008-05-09 |
| ENTRUST ICD (P980016/S111) | Medtronic Cardiac Rhythm Disease Management | 2008-05-09 |
| COGNIS CARDIAC RESYNCHRONIZATION HIGH ENERGY DEFIBRILLATOR (P010012/S179) | Boston Scientific Corp | 2008-05-08 |
| TELIGEN ICD (P960040/S155) | Boston Scientific | 2008-05-08 |
| COGNIS CRT-D (P010012/S165) | Boston Scientific Corp | 2008-05-08 |
| TELIGEN FAMILY OF ICDS (P960040/S167) | Boston Scientific | 2008-05-08 |
| GORE HELEX SEPTAL OCCLUDER (P050006/S006) | W. L. Gore & Associates, Inc. | 2008-05-07 |
| BIOCOR VALVE AND BIOCOR SUPRA VALVE\ (P040021/S006) | ABBOTT MEDICAL | 2008-05-06 |
| EPIC HF/ATLAS+HF FAMILY OF CRT-DS (P030054/S084) | ABBOTT MEDICAL | 2008-05-02 |
| CADENCE FAMILY OF ICDS (P910023/S170) | ABBOTT MEDICAL | 2008-05-02 |
| SPRINT LEADS & SPRINT QUATTRO & SECURE LEAD & SPRINT FIDELIS LEADS (P920015/S043) | Medtronic, Inc. | 2008-05-01 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENTS (P020026/S051) | Cordis Corp. | 2008-05-01 |
| EPIC HF CRT-D SYSTEM (P030054/S086) | ABBOTT MEDICAL | 2008-04-30 |
| LIBERTE CORONARY STENT SYSTEM (OTW) (P040016/S029) | Boston Scientific Scimed, Inc. | 2008-04-30 |
| SVC TRANSVENE LEAD (P920015/S042) | Medtronic, Inc. | 2008-04-30 |
| EXPRESS2 CORONARY STENT SYSTEM (OTW) (P020009/S042) | Boston Scientific Scimed, Inc. | 2008-04-30 |
| TAXUS EXPRESS2 PACLITAXEL ELUTING STENT SYSTEM (OTW) (P030025/S054) | Boston Scientific Corp | 2008-04-30 |
| CADENCE ICD SYSTEM (P910023/S173) | ABBOTT MEDICAL | 2008-04-30 |
| MAVERICK2 MONORAIL, MAVERICK (OTW), QUANTUM MAVERICK (OTW) PTCA CATHETERS (P860019/S224) | Scimed Life Systems, Inc. | 2008-04-30 |
| SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS (P880006/S056) | St. Jude Medical, Inc. | 2008-04-29 |
| MICRONY FAMILY OF PACEMAKERS (P970013/S023) | ABBOTT MEDICAL | 2008-04-29 |
| CADENCE FAMILY OF ICDS (P910023/S172) | ABBOTT MEDICAL | 2008-04-29 |
| FRONTIER/FRONTIER II FAMILY OF CRT-PS (P030035/S041) | ABBOTT MEDICAL | 2008-04-29 |
| SPRINT QUATTRO SECURE S SINGLE COIL IS-1/DF-1, ACTIVE FIX LEAD MODEL 6935 (P920015/S039) | Medtronic, Inc. | 2008-04-29 |