| PROVISC OPHTHALMIC VISCOSURGICAL DEVICE (P890047/S024) | Alcon Research, Ltd. | 2008-12-15 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P070015/S008) | Abbott Vascular, Inc. | 2008-12-15 |
| MYNX VASCULAR CLOSURE DEVICE (P040044/S007) | Cordis US Corporation | 2008-12-14 |
| DEFLUX INJECTABLE GEL (P000029/S052) | Palette Life Sciences | 2008-12-12 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S002) | Abbott Vascular, Inc. | 2008-12-12 |
| EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS (P000007/S014) | Edwards Lifesciences, LLC | 2008-12-12 |
| JEWEL AND GEM FAMILIES OF ICDS (P900061/S079) | Medtronic Cardiac Rhythm Disease Management | 2008-12-11 |
| VARIOUS FAMILIES OF PACEMAKERS (P850051/S069) | Medtronic, Inc. | 2008-12-11 |
| VARIOUS FAMILIES OF PACEMAKERS (P820003/S087) | Medtronic Cardiac Rhythm Disease Management | 2008-12-11 |
| COGNIS CARDIAC RESYNCHRONIZATION HE DEFIBRILLATOR (P010012/S194) | Boston Scientific Corp | 2008-12-11 |
| VARIOUS FAMILIES OF CRT / ICDS (P010031/S130) | Medtronic Cardiac Rhythm Disease Management | 2008-12-11 |
| TELIGEN FAMILY (P960040/S182) | Boston Scientific | 2008-12-11 |
| LEGEND PLUS FAMILY OF PACEMAKERS (P930022/S008) | Medtronic, Inc. | 2008-12-11 |
| INSYNC PACEMAKER AND INSYNC III CRT-IPG (P010015/S055) | Medtronic, Inc. | 2008-12-11 |
| CARDIOMESSENGER II-S AND CARDIOMESSENGER II-S TLINE HOME MONITORING DEVICES (P050023/S016) | Biotronik, Inc. | 2008-12-11 |
| KAPPA, SIGMA, ENRHYTHM, ENPULSE, ADAPTA AND RELIA FAMILIES OF PACEMAKERS (P980035/S118) | Medtronic, Inc. | 2008-12-11 |
| VIATRON PACEMAKERS (P990001/S046) | Medtronic, Inc. | 2008-12-11 |
| GEM, ENTRUST, MARQUIS, MAXIMO, INTRINSIC AND VIRTUSO FAMILIES OF ICDS (P980016/S163) | Medtronic Cardiac Rhythm Disease Management | 2008-12-11 |
| VARIOUS FAMILIES OF PACEMAKERS, CARELINK PROGRAMMER MODEL 2090 (P890003/S151) | Medtronic, Inc. | 2008-12-11 |
| KAPPA/SIGMA/ENPULSE/ADAPTA/VERSA/SENSIA PACEMAKER FAMILIES (P980035/S120) | Medtronic, Inc. | 2008-12-11 |
| BOSTON SCIENTIFIC EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006) | Boston Scientific Corp | 2008-12-11 |
| ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S022) | Medtronic, Inc. | 2008-12-11 |
| ANGIOPLASTY/LASER/CORONARY DEVICE (P910001/S028) | Spectranetics Corp. | 2008-12-11 |
| 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 |
| APLIGRAF (P950032/S049) | Organogenesis, 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 |
| HARMONY HIRESOLUTION BIONIC EAR SYSTEM (P960058/S073) | Advanced Bionics | 2008-12-09 |
| UROLOGIX TARGIS SYSTEM (P970008/S041) | Urologix, LLC | 2008-12-09 |
| PROLIEVE THERMODILITATION SYSTEM (P030006/S020) | Medifocus, Inc. | 2008-12-09 |
| ISPAN SULFUR HEXAFLUORIDE SF6 GAS (P900067/S005) | Airgas Therapeutics, LLC | 2008-12-09 |
| PRECISION SPINAL CORD STIMULATION SYSTEM (P030017/S090) | Boston Scientific Corp | 2008-12-09 |
| SIROLIMUS-ELUTING STENT ON RAPTOR OTW DELIVERY SYSTEM & RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (P020026/S058) | Cordis Corp. | 2008-12-08 |
| RESTORE, RESTOREPRIME, RESTOREADVANCED, RESTORE PRIME ADVANCED, AND RESTOREULTRA NEUROSTIMULATION SYSTEMS (P840001/S122) | Medtronic Neuromodulation | 2008-12-08 |
| OVATIO VR 6250 & DR 6550 ICDS (P980049/S029) | MicroPort CRM USA, Inc. | 2008-12-05 |
| RADIESSE INJECTABLE IMPLANT (P050037/S015) | Merz North America, Inc. | 2008-12-05 |
| RADIESSE INJECTABLE IMPLANT (P050052/S016) | Merz North America, Inc. | 2008-12-05 |
| PTCA CATHETERS (P860019/S221) | Scimed Life Systems, Inc. | 2008-12-04 |
| INFUSE BONE GRAFT (P000054/S017) | Medtronic Sofamor Danek USA, Inc. | 2008-12-04 |
| EXPRESS2 CORONARY STENT SYSTEM (P020009/S040) | Boston Scientific Scimed, Inc. | 2008-12-04 |
| INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S028) | Medtronic Sofamor Danek USA, 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 |
| COSEAL SURGICAL SEALANT (P030039/S012) | Baxter Bio Science | 2008-12-04 |
| ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S020) | Medtronic, Inc. | 2008-12-04 |
| INFUSE BONE GRAFT (P050053/S006) | 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 |
| COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030/S001) | Roche Molecular Systems, Inc. | 2008-12-04 |
| CADENCE FAMILY OF ICDS (P910023/S193) | ABBOTT MEDICAL | 2008-12-04 |
| ROCHE MOLECULAR SYSTEMS COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST (P000012/S018) | Roche Molecular Systems, Inc. | 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 |
| THE DEXCOM SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM (P050012/S017) | Dexcom, 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 |
| DERMAGRAFT (P000036/S006) | Shire Regenerative Medicine | 2008-12-03 |
| TRANSVENOUS,STEROID ELUTING,QUADRIPOLAR,ACTIVE FIXATION, PACE/SENSE VENTRICULAR LEAD (P920015/S050) | Medtronic, Inc. | 2008-12-03 |
| BD FOCALPOINT GS IMAGING SYSTEM (P950009/S008) | Bd Diagnostics | 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 |
| VISX STAR S4 IR EXCIMER LASER SYSTEM (P930016/S031) | Amo Manufacturing USA, LLC | 2008-12-01 |
| SURGICEL ABSORBABLE HEMOSTAT (SURGICEL, SURGICEL NU-KNIT AND SURGICEL FIBRILLAR ABSORBABLE HEMOSTATS) (N12159/S023) | ETHICON, Inc. | 2008-11-26 |
| 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 |
| INTERCEED ABSORBABLE ADHESION BARRIER (P880047/S012) | ETHICON, Inc. | 2008-11-26 |
| PROVISC OPHTHALMIC VISCOSURGICAL DEVICE (P890047/S025) | Alcon Research, Ltd. | 2008-11-26 |
| CELLUGEL OPHTHALMIC VISCOSURGICAL DEVICE (P990023/S005) | Alcon Laboratories | 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 |
| VISCOAT, DUOVISC, DISCOVISC, PROVISC AND CELLUGEL OPHTHALMIC VISCOSURGICAL DEVICES (P840064/S037) | Alcon Laboratories | 2008-11-26 |
| COBAS TAQMAN HBV TEST (P050028/S002) | Roche Molecular Systems, Inc. | 2008-11-25 |
| ADAPTA, VERSA, & SENSIA FAMILY OF PACEMAKERS (P980035/S119) | Medtronic, Inc. | 2008-11-25 |