| NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM (P000015/S010) | Cochlear Americas | 2007-12-31 |
| FLOSEAL HEMOSTATIC MATRIX (P990009/S021) | Baxter Healthcare Corp | 2007-12-27 |
| TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S050) | Boston Scientific Corp | 2007-12-27 |
| SURGIFOAM ABSORBABLE GELATIN SPONGE (P990004/S013) | Ferrosan Meidcal Devices A/S | 2007-12-27 |
| INFUSE BONE GRAFT (P000054/S009) | Medtronic Sofamor Danek USA, Inc. | 2007-12-21 |
| INFUSE BONE GRAFT/LT-CAGE TAPERED FUSION DEVICE (P000058/S020) | Medtronic Sofamor Danek USA, Inc. | 2007-12-21 |
| RIATA ST FAMILY OF LEADS (P950022/S046) | ABBOTT MEDICAL | 2007-12-21 |
| VNS THERAPY SYSTEM (P970003/S093) | LivaNova USA, Inc. | 2007-12-21 |
| AB5000 CIRCULATORY SUPPORT SYSTEM (P900023/S048) | Abiomed Cardiovascular, Inc. | 2007-12-21 |
| VENTAK AV AICD SYSTEM (P960040/S148) | Boston Scientific | 2007-12-20 |
| CONTAK RENEWAL TR CRT-P SYSTEM (P030005/S046) | Guidant Corp. | 2007-12-20 |
| CONTAK CD/EASYTRACK CRT SYSTEM (P010012/S155) | Boston Scientific Corp | 2007-12-20 |
| VNS THERAPY SYSTEM (P970003/S091) | LivaNova USA, Inc. | 2007-12-20 |
| HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM (P000032/S023) | CooperSurgical, Inc. | 2007-12-20 |
| NEXSTENT CAROTID STENT & MONORAIL DELIVERY SYSTEM (P050025/S007) | Boston Scientific | 2007-12-20 |
| VENTAK MINI AICD SYSTEM (P910077/S076) | Boston Scientific | 2007-12-20 |
| VNS THERAPY SYSTEM (P970003/S090) | LivaNova USA, Inc. | 2007-12-20 |
| DELTA/VISTA AND VIGOR (P840068/S046) | Boston Scientific | 2007-12-20 |
| PULSAR/PULSAR MAX/ DISCOVERY/MERIDIAN (P940031/S061) | Boston Scientific | 2007-12-20 |
| INFUSE BONE GRAFT/ LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S022) | Medtronic Sofamor Danek USA, Inc. | 2007-12-20 |
| SYNCHROMED ISOMED IMPLANTABLE INFUSION PUMPS (P990034/S010) | Medtronic, Inc. | 2007-12-19 |
| SYNCHROMED ISOMED IMPLANTABLE INFUSION PUMPS (P860004/S091) | Medtronic, Inc. | 2007-12-19 |
| VNS THERAPY SYSTEM (P970003/S095) | LivaNova USA, Inc. | 2007-12-19 |
| ABBOTT AXSYM HBSAG (P050049/S002) | Abbott Laboratories, Inc. | 2007-12-19 |
| SAFIRE BIDIRECTIONAL ABLATION CATHETER (P960016/S020) | St Jude Medical | 2007-12-19 |
| EPIC HF FAMILY CRT-D'S (P030054/S073) | ABBOTT MEDICAL | 2007-12-19 |
| RIATA FAMILY OF LEADS (P950022/S048) | ABBOTT MEDICAL | 2007-12-19 |
| CADENCE FAMILY ICD'S (P910023/S161) | ABBOTT MEDICAL | 2007-12-19 |
| VNS THERAPY SYSTEM (P970003/S094) | LivaNova USA, Inc. | 2007-12-19 |
| RELIANCE FAMILY OF LEADS (P910073/S068) | Boston Scientific | 2007-12-19 |
| CONCERTO (P010031/S086) | Medtronic Cardiac Rhythm Disease Management | 2007-12-18 |
| RIATA FAMILY OF LEADS (P950022/S047) | ABBOTT MEDICAL | 2007-12-18 |
| FLEXTIP PLUS INTRASPINAL CATHETER KIT (P890055/S024) | Intera Oncology | 2007-12-18 |
| ENTRUST & VIRTUOSO (P980016/S116) | Medtronic Cardiac Rhythm Disease Management | 2007-12-18 |
| ENRHYTHM (P980035/S082) | Medtronic, Inc. | 2007-12-18 |
| TENDRIL FAMILY OF LEADS (P960013/S036) | ABBOTT MEDICAL | 2007-12-18 |
| INTERSTIM THERAPY FOR URINARY CONTROL (P970004/S045) | Medtronic Neuromodulation | 2007-12-18 |
| SPINAL CORD STIMULATION (P840001/S103) | Medtronic Neuromodulation | 2007-12-18 |
| VITAGEL SURGICAL HEMOSTAT (P050044/S003) | Stryker Corp. | 2007-12-17 |
| VITAGEL SURGICAL HEMOSTAT (P050044/S002) | Stryker Corp. | 2007-12-17 |
| MYNX VASCULAR CLOSURE DEVICE (P040044/S004) | Cordis US Corporation | 2007-12-17 |
| THERMATRX OFFICE THERMOTHERAPY SYSTEM (P000043/S020) | Boston Scientific Corp | 2007-12-17 |
| PRODISC TM-C TOTAL DISC REPLACEMENT (P070001) | Centinel Spine, LLC | 2007-12-17 |
| MONOPREP PAP TEST (P040052/S001) | Hologic, Inc. | 2007-12-14 |
| VERSANT HCV RNA 3.0 ASSAY (BDNA) (P020022/S006) | Siemens Healthcare Diagnostics, Inc. | 2007-12-14 |
| X-STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM (P040001/S008) | Medtronic Sofamor Danek, Inc. | 2007-12-14 |
| VISCOAT,DUOVISC & DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE (P840064/S033) | Alcon Laboratories | 2007-12-14 |
| AFFINITY/INTEGRITY/VICTORY/ZEPHYR FAMILY OF PACEMAKERS (P880086/S158) | ABBOTT MEDICAL | 2007-12-14 |
| COSEAL SURGICAL SEALANT (P030039/S008) | Baxter Bio Science | 2007-12-14 |
| PROVISC OPHTHALMIC VISCOSURGICAL DEVICE (P890047/S020) | Alcon Research, Ltd. | 2007-12-14 |
| VNS THERAPY SYSTEM (P970003/S077) | LivaNova USA, Inc. | 2007-12-14 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S047) | Cordis Corp. | 2007-12-13 |
| CYPHER SIROLIMUS ELUTING CORONARY STENT (P020026/S045) | Cordis Corp. | 2007-12-13 |
| CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS (P870077/S025) | Edwards Lifesciences, LLC | 2007-12-13 |
| CARPENTIER-EDWARDS SUPRA-ANNULAR (S.A.V.) BIOPROSTHESIS (P010041/S014) | Edwards Lifesciences, LLC | 2007-12-13 |
| SURGIFOAM ABSORBABLE GELATIN SPONGE (P990004/S012) | Ferrosan Meidcal Devices A/S | 2007-12-13 |
| GELFOAM PLUS HEMOSTATIC KIT (N18286/S017) | Pfizer, Inc. | 2007-12-13 |
| CARPENTIER-EDWARDS BIOPROSTHESIS (P870056/S027) | Edwards Lifesciences, LLC | 2007-12-13 |
| EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS (P000007/S013) | Edwards Lifesciences, LLC | 2007-12-13 |
| EON AND GENESIS RC NEUROSTIMULATION SYSTEMS (P010032/S019) | ABBOTT MEDICAL | 2007-12-13 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P860057/S044) | Edwards Lifesciences, LLC | 2007-12-13 |
| ADATO SIL-OL 5000 SILICONE OIL (P910071/S010) | Bausch & Lomb | 2007-12-12 |
| CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR (IOL) (P030002/S013) | Bausch & Lomb, Inc. | 2007-12-12 |
| MICRONY FAMILY OF PACEMAKERS (P970013/S022) | ABBOTT MEDICAL | 2007-12-12 |
| AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS (P880086/S156) | ABBOTT MEDICAL | 2007-12-12 |
| CADENCE FAMILY OF ICDS (P910023/S162) | ABBOTT MEDICAL | 2007-12-12 |
| SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS (P880006/S055) | St. Jude Medical, Inc. | 2007-12-12 |
| MOSAIC PORCINE BIOPROSTHESIS, MODELS 305, 310 (P990064/S022) | Medtronic, Inc. | 2007-12-12 |
| EPIC HF/ATLAS + HF FAMILY OF CRT-DS (P030054/S074) | ABBOTT MEDICAL | 2007-12-12 |
| PATHWAY ANTI-HER-2/NEU (P990081/S007) | Ventana Medical Systems, Inc. | 2007-12-12 |
| HANCOCK II PORCINE BIOPROSTHESIS, MODELS T505 AND T510 (P980043/S015) | Medtronic, Inc. | 2007-12-12 |
| FRONTIER/FRONTIER II FAMILY OF CRT-PS (P030035/S037) | ABBOTT MEDICAL | 2007-12-12 |
| SYNCHROMED II PUMP (P860004/S095) | Medtronic, Inc. | 2007-12-11 |
| ITREL 3, SYNERGY, RESTORE PRIME & PRIME ADVANCED FAMILY OF IPGS OR IMPLANTABLE NEUROSTIMULATOR (P840001/S104) | Medtronic Neuromodulation | 2007-12-11 |
| INTERSTIM FAMILY OF NEUROSTIMULATOR (P970004/S046) | Medtronic Neuromodulation | 2007-12-11 |
| PRODIGY/THERA I IPG (P890003/S132) | Medtronic, Inc. | 2007-12-11 |
| VARIOUS FAMILIES OF PACEMAKERS (P980035/S083) | Medtronic, Inc. | 2007-12-11 |
| INSYNC FAMILIES OF ICD & CONCERTO ICD (P010031/S087) | Medtronic Cardiac Rhythm Disease Management | 2007-12-11 |
| FRONTIER/FRONTIER II FAMILY OF CRT-PS (P030035/S038) | ABBOTT MEDICAL | 2007-12-11 |
| AFFINITY/INTEGRITY/VICTORY/ZEPHYR FAMILY OF PACEMAKERS (P880086/S157) | ABBOTT MEDICAL | 2007-12-11 |
| GRUNTZIG DILACA CORONARY ARTERY BALLOON DILATION CATHETER (P790017/S093) | Medtronic, Ireland | 2007-12-11 |
| VARIOUS FAMILIES OF ICDS (P980016/S117) | Medtronic Cardiac Rhythm Disease Management | 2007-12-11 |
| OPEN PIVOT BI-LEAFLET MECHANICAL HEART VALVE (P990046/S016) | Medtronic Ats Medical, Inc. | 2007-12-11 |
| KAPPA 400 DR & SR PACEMAKERS (P970012/S032) | Medtronic, Inc. | 2007-12-11 |
| KINETRA & SOLETRA FAMILY OF NEUROSTIMULATORS (P960009/S045) | Medtronic, Inc. | 2007-12-11 |
| IPULSE CIRCULATORY SUPPORT SYSTEM (P900023/S047) | Abiomed Cardiovascular, Inc. | 2007-12-11 |
| INSYNC CRT-P & INSYNC III CRT-P (P010015/S036) | Medtronic, Inc. | 2007-12-11 |
| OL1000 DUAL COIL MEDIUM BONE GROWTH STIMULATION DEVICE (P910066/S024) | Djo, LLC | 2007-12-10 |
| ABBOTT ARCHITECT ANTI-HCV (P050042/S003) | Abbott Laboratories, Inc. | 2007-12-10 |
| NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM (P060037) | Zimmer, Inc. | 2007-12-10 |
| ANS EON C (IPG) NEUROSTIMULATION SYSTEM (P010032/S021) | ABBOTT MEDICAL | 2007-12-10 |
| KRONOS LV-T CRT-D & LUMAX VR/DR/HF (-T) ICDS & CDT-DS (P050023/S006) | Biotronik, Inc. | 2007-12-07 |
| LEXOS DR/VR(-T) ICDS & LUMOS VR/DR (-T) & XELOS DR-T ICD & BELOS DR (-T) ICDS (P000009/S022) | Biotronik, Inc. | 2007-12-07 |
| ICS 3000 IMPLANT CONTROL SYSTEM (P950037/S055) | Biotronik, Inc. | 2007-12-07 |
| CARDIAC AIRBAG (-T) ICDS & BELOS VR (-T) ICDS & TMS 1000 PLUS PROGRAMMING SYSTEM (P980023/S029) | Biotronik, Inc. | 2007-12-07 |
| CADENCE TIERED-THERAPY DEFIBRILLATOR SYSTEM (P910023/S160) | ABBOTT MEDICAL | 2007-12-07 |
| CYLOS PACEMAKER & PHILOS II PACEMAKERS & ICS 3000 IMPLANT CONTROL SYSTEM & IMPLANT MODULE (P950037/S053) | Biotronik, Inc. | 2007-12-07 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S006) | W. L. Gore & Associates, Inc. | 2007-12-06 |
| GORE HELEX SEPTAL OCCLUDER (P050006/S005) | W. L. Gore & Associates, Inc. | 2007-12-06 |
| ANEURX AAADVANTAGE XCELERANT HYDRO DELIVERY SYSTEM (P990020/S028) | Medtronic Vascular | 2007-12-06 |