| KAPPA 400 FAMILY OF PACEMAKERS (P970012/S045) | Medtronic, Inc. | 2008-12-11 |
| PRODIGY SR, ENRHYTHM IPG MODEL P150DR (P890003/S156) | Medtronic, Inc. | 2008-12-11 |
| KAPPA 400 DR/SR (P970012/S046) | Medtronic, Inc. | 2008-12-11 |
| SMART NITINOL STENT SYSTEM & SMART CONTROL NITINOL STENT SYSTEM (P020036/S012) | Cordis US Corporation | 2008-12-11 |
| JEWEL AF, GEMIII AT FAMILY OF ICDS (P980050/S037) | Medtronic, Inc. | 2008-12-11 |
| MULTI-LINK FAMILY OF CORONARY STENT SYSTEMS (CSS) (P970020/S054) | Abbott Vascular, Inc. | 2008-12-10 |
| MULTI-LINK VISION FAMILY OF CORONARY STENT SYSTEMS (CSS) (P020047/S014) | Abbott Vascular | 2008-12-10 |
| THERAPY CARDIAC ABLATION CATHETER (P040014/S009) | Irvine Biomedical, Inc. | 2008-12-10 |
| ISOLINE 2CR, ISOLINE 2CT STEROID ELUTING PACING LEADS (P980049/S043) | MicroPort CRM USA, Inc. | 2008-12-10 |
| ACCULINK CAROTID STENT SYSTEMS (P040012/S028) | Abbott Vascular | 2008-12-10 |
| SIMPSON-ROBERT FAMILY OF CORONARY DILATATION CATHETERS (P810046/S227) | Advanced Cardiovascular Systems, Inc. | 2008-12-10 |
| THERAPY DUAL 8 ABLATION CATHETERS (P040042/S014) | Irvine Biomedical,Inc.(Ibi) | 2008-12-10 |
| THERAPY COOL PATH ABLATION CATHETERS (P060019/S007) | Irvine Biomedical, Inc. | 2008-12-10 |
| MEDTRONIC HALL PROSTHETIC HEART VALVE/EASY-FIT/AORTIC VALVED CONDUIT/COLLAGEN IMPREGNATED CONDUIT/ROTATABLE AORTIC (P790018/S050) | Medtronic Cardiac Surgery | 2008-12-09 |
| SIROLIMUS-ELUTING STENT ON RAPTOR OTW DELIVERY SYSTEM & RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (P020026/S058) | Cordis Corp. | 2008-12-08 |
| OVATIO VR 6250 & DR 6550 ICDS (P980049/S029) | MicroPort CRM USA, Inc. | 2008-12-05 |
| PTCA CATHETERS (P860019/S221) | Scimed Life Systems, Inc. | 2008-12-04 |
| EXPRESS2 CORONARY STENT SYSTEM (P020009/S040) | Boston Scientific Scimed, Inc. | 2008-12-04 |
| MULTI-LINK VISION RX FAMILY OF CORONARY STENT SYSTEMS (P020047/S013) | Abbott Vascular | 2008-12-04 |
| XIENCE V RX EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S007) | Abbott Vascular, Inc. | 2008-12-04 |
| TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S049) | Boston Scientific Corp | 2008-12-04 |
| BARD E-LUMINEXX VASCULAR STENT (P080007) | Bard Peripheral Vascular, Inc. | 2008-12-04 |
| LIBERTE MR & OTW CORONARY STENT SYSTEM (P040016/S026) | Boston Scientific Scimed, Inc. | 2008-12-04 |
| ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S020) | Medtronic, Inc. | 2008-12-04 |
| EPIC HF/ATLAS + HF FAMILY OF CRT-DS (P030054/S108) | ABBOTT MEDICAL | 2008-12-04 |
| MULTI-LINK RX ZETA CORONARY STENT SYSTEMS (P970020/S053) | Abbott Vascular, Inc. | 2008-12-04 |
| CADENCE FAMILY OF ICDS (P910023/S193) | ABBOTT MEDICAL | 2008-12-04 |
| FRONTIER/FRONTIER II FAMILY OF CRT-PS (P030035/S049) | ABBOTT MEDICAL | 2008-12-04 |
| AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS (P880086/S170) | ABBOTT MEDICAL | 2008-12-04 |
| ATTAIN BIPOLAR OTW/OTW/CS LEAD (P010015/S056) | Medtronic, Inc. | 2008-12-03 |
| EPICARDIAL TRANSVENE LEAD, CABLE HEADER, ACE HEADER, UPSIZING SLEEVE FOR HV LEAD DF-1, UPSIZING SLEEVE, END CAP (P900061/S080) | Medtronic Cardiac Rhythm Disease Management | 2008-12-03 |
| LEAD ASSEMBLY (P030036/S010) | Medtronic Cardiac Rhythm Disease Management | 2008-12-03 |
| TRANSVENOUS,STEROID ELUTING,QUADRIPOLAR,ACTIVE FIXATION, PACE/SENSE VENTRICULAR LEAD (P920015/S050) | Medtronic, Inc. | 2008-12-03 |
| LEADS SERVICE & WRENCH KIT (P890003/S153) | Medtronic, Inc. | 2008-12-03 |
| CAPSURE EPI EPICARDIAL STEROID ELUTING PACING LEAD (P950024/S013) | Medtronic, Inc. | 2008-12-03 |
| THORATEC HEARTMATE II LVAS (P060040/S002) | ABBOTT MEDICAL | 2008-12-03 |
| ATTAIN STARFIX LEAD (P060039/S004) | Medtronic, Inc. | 2008-12-03 |
| SVC/CS TRANSVENE LEAD (P980050/S038) | Medtronic, Inc. | 2008-12-03 |
| CADENCE ICD (P910023/S183) | ABBOTT MEDICAL | 2008-11-26 |
| ENDEAVOR & ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P060033/S024) | Medtronic, Inc. | 2008-11-26 |
| TAXUS LIBERTE OVER-THE-WIRE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S005) | Boston Scientific Corp | 2008-11-26 |
| EPIC HF/ATLAS + HF CRT-D (P030054/S098) | ABBOTT MEDICAL | 2008-11-26 |
| MEDTRONIC RELIA IMPLANTABLE PULSE GENERATOR AND MODEL SW010APPLICATION SOFTWARE (P980035/S097) | Medtronic, Inc. | 2008-11-26 |
| ISOFLEX OPTIM FAMILY OF LEADS (P960030/S024) | ABBOTT MEDICAL | 2008-11-26 |
| ATS 3F AORTIC BIOPROSTHESIS (P060025/S001) | Medtronic, Inc. | 2008-11-26 |
| SPRINT QUATTRO SECURE LEADS MODELS 6935 & 6947 (P920015/S049) | Medtronic, Inc. | 2008-11-26 |
| ZENITH TX2 THORACIC TAA ENDOVASCULAR GRAFT WITH THE H&LB ONE-SHOT INTRODUCTION SYSTEM (P070016/S001) | William Cook Europe Aps | 2008-11-26 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S038) | W. L. Gore & Associates, Inc. | 2008-11-26 |
| CURRENT FAMILY OF ICDS (P910023/S194) | ABBOTT MEDICAL | 2008-11-26 |
| EPIC HF/ATLAS + HF FAMILY OF CRT-DS (P030054/S109) | ABBOTT MEDICAL | 2008-11-26 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL & OVER-THE-WIRE) (P060008/S006) | Boston Scientific Corp | 2008-11-26 |
| ADAPTA, VERSA, & SENSIA FAMILY OF PACEMAKERS (P980035/S119) | Medtronic, Inc. | 2008-11-25 |
| ZENITH TX2 TAA ENDOVASCULAR GRAFT (P070016/S002) | William Cook Europe Aps | 2008-11-25 |
| CYLOS DR-T PULSE GENERATOR (P950037/S064) | Biotronik, Inc. | 2008-11-24 |
| VARIOUS FAMILIES OF PACEMAKERS (P980035/S107) | Medtronic, Inc. | 2008-11-21 |
| INSYNC & INSYNC III CRT-P (P010015/S048) | Medtronic, Inc. | 2008-11-21 |
| CAPACITORS SOAK (P010012/S193) | Boston Scientific Corp | 2008-11-21 |
| IMPLANTABLE PACEMAKER/ICD PROGRAMMER (P890003/S145) | Medtronic, Inc. | 2008-11-21 |
| VARIOUS FAMILIES OF ICDS (P900061/S077) | Medtronic Cardiac Rhythm Disease Management | 2008-11-21 |
| PREVAIL (P850051/S068) | Medtronic, Inc. | 2008-11-21 |
| KAPPA 400 DR & SR IPG PACEMAKERS (P970012/S038) | Medtronic, Inc. | 2008-11-21 |
| INSYNC CRT-D/CONCERTO & VARIOUS INSYNC FAMILY OF ICDS (P010031/S114) | Medtronic Cardiac Rhythm Disease Management | 2008-11-21 |
| CARDIAC AIRBAG-T AND BELOS VR-T IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P980023/S035) | Biotronik, Inc. | 2008-11-21 |
| LEGEND PLUS FAMILY OF PACEMAKERS (P930022/S007) | Medtronic, Inc. | 2008-11-21 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY SYSTEM (P060008/S001) | Boston Scientific Corp | 2008-11-21 |
| LUMAX FAMILY OF ICDS (P050023/S018) | Biotronik, Inc. | 2008-11-21 |
| GEM III AT ICD (P980050/S035) | Medtronic, Inc. | 2008-11-21 |
| TELEGIN FAMILY OF ICDS (P960040/S179) | Boston Scientific | 2008-11-21 |
| VARIOUS FAMILIES OF PACEMAKERS (P990001/S039) | Medtronic, Inc. | 2008-11-21 |
| STRATOS LV-T PULSE GENERATOR (P070008/S007) | Biotronik, Inc. | 2008-11-21 |
| PHILOS II FAMILY OF PULSE GENERATORS (P950037/S066) | Biotronik, Inc. | 2008-11-21 |
| VARIOUS FAMILIES OF ICDS (P980016/S145) | Medtronic Cardiac Rhythm Disease Management | 2008-11-21 |
| LEXOS & LUMOS FAMILIES OF ICDS (P000009/S031) | Biotronik, Inc. | 2008-11-21 |
| CADENCE FAMILY OF ICDS (P910023/S192) | ABBOTT MEDICAL | 2008-11-21 |
| EXTERNAL PULSE GENERATOR (P820003/S084) | Medtronic Cardiac Rhythm Disease Management | 2008-11-21 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S002) | Boston Scientific Corp | 2008-11-20 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S003) | Boston Scientific Corp | 2008-11-20 |
| ENDEAVOR ZOTAROLIMUS-ELUTING & ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S018) | Medtronic, Inc. | 2008-11-20 |
| MEDTRONIC ADAPTA, VERSA AND SENSIA PACEMAKERS (P980035/S102) | Medtronic, Inc. | 2008-11-19 |
| BETA-CATH SYSTEM (P000018/S043) | Best Vascular, Inc. | 2008-11-19 |
| ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S017) | Medtronic, Inc. | 2008-11-19 |
| LIBERTE MONORAIL AND OVER-THE-WIRE CORONARY STENT SYSTEMS (P040016/S005) | Boston Scientific Scimed, Inc. | 2008-11-18 |
| TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S051) | Boston Scientific Corp | 2008-11-18 |
| LATITUDE COMMUNICATOR SOFTWARE & SYSTEM SOFTWARE (P910077/S090) | Boston Scientific | 2008-11-17 |
| ZENITH FLEX AAA ENDOVASCULAR GRAFT RENU AAA ANCILLARY GRAFT (P020018/S029) | Cook, Inc. | 2008-11-17 |
| TELIGEN ICD (P960040/S174) | Boston Scientific | 2008-11-17 |
| COGNIS CRT-D (P010012/S189) | Boston Scientific Corp | 2008-11-17 |
| SPRINT QUATTRO SECURE LEAD (P920015/S045) | Medtronic, Inc. | 2008-11-14 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S052) | Cordis Corp. | 2008-11-14 |
| FREEZOR CARDIAC CRYOABLATION CATHETER/ FREEZOR XTRA & MAX SURGICAL CRYOABLATION & CCT.2 CRYOCONSOLE SYSTEM (P020045/S025) | Medtronic Cryocath, LP | 2008-11-14 |
| EPIC HF/ATLAS + HF FAMILY OF CRT-DS (P030054/S106) | ABBOTT MEDICAL | 2008-11-14 |
| EPIC HF CRT-D SYSTEM (P030054/S107) | ABBOTT MEDICAL | 2008-11-14 |
| ST JUDE MEDICAL REGENT MECHANICAL HEART VALVE (P810002/S068) | ABBOTT MEDICAL | 2008-11-14 |
| CADENCE ICD SYSTEM (P910023/S191) | ABBOTT MEDICAL | 2008-11-14 |
| VITALITY FAMILY OF ICDS (P960040/S178) | Boston Scientific | 2008-11-14 |
| MEDTRONIC MODEL 2490C & 2490R CARELINK MONITORS (P890003/S152) | Medtronic, Inc. | 2008-11-14 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S012) | Zoll Manufacturing Corporation | 2008-11-14 |
| CADENCE FAMILY OF ICDS (P910023/S190) | ABBOTT MEDICAL | 2008-11-14 |
| DRIVER CORONARY STENT SYSTEMS (P030009/S027) | Medtronic, Ireland | 2008-11-13 |
| VIRTUOSO ICD (P980016/S162) | Medtronic Cardiac Rhythm Disease Management | 2008-11-13 |