| INTERSTIM THERAPY (P970004/S063) | Medtronic Neuromodulation | 2008-11-25 |
| LAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM (P000008/S013) | Medtimo, Inc. | 2008-11-25 |
| ZENITH TX2 TAA ENDOVASCULAR GRAFT (P070016/S002) | William Cook Europe Aps | 2008-11-25 |
| AMPLICOR MYCOBACTERIUM TUBERCULOSIS (MTB) TEST (P940040/S010) | Roche Molecular Systems, Inc. | 2008-11-25 |
| INFUSE BONE GRAFT / LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S029) | Medtronic Sofamor Danek USA, Inc. | 2008-11-24 |
| CYLOS DR-T PULSE GENERATOR (P950037/S064) | Biotronik, Inc. | 2008-11-24 |
| PARADIGM REALTIME INSULIN PUMP (P980022/S040) | Medtronic Minimed | 2008-11-24 |
| INFUSE BONE GRAFT (P050053/S009) | Medtronic, Inc. | 2008-11-24 |
| CARELINK PRO PC SOFTWARE (P980022/S034) | Medtronic Minimed | 2008-11-24 |
| INFUSE BONE GRAFT (P000054/S018) | Medtronic Sofamor Danek USA, 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 |
| OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM (P010014/S022) | Biomet Manufacturing Corp | 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 |
| POLYMACON SOFT (HYDROPHILIC) CONTACT LENSES (P780007/S044) | CooperVision, Inc. | 2008-11-21 |
| VITAGEL SURGICAL HEMOSTAT (P050044/S007) | Stryker Corp. | 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 |
| RADIESSE INJECTABLE IMPLANT (P050052/S015) | Merz North America, 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 |
| RADIESSE INJECTABLE IMPLANT (P050037/S014) | Merz North America, Inc. | 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 MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM (P980022/S039) | Medtronic Minimed | 2008-11-20 |
| EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM (P050039/S002) | Exactech, Inc. | 2008-11-19 |
| UROLOGIX TARGIX SYSTEM (P970008/S040) | Urologix, LLC | 2008-11-19 |
| MEDTRONIC ADAPTA, VERSA AND SENSIA PACEMAKERS (P980035/S102) | Medtronic, Inc. | 2008-11-19 |
| BETA-CATH SYSTEM (P000018/S043) | Best Vascular, Inc. | 2008-11-19 |
| AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS (P060022/S001) | Bausch & Lomb, Inc. | 2008-11-19 |
| ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S017) | Medtronic, Inc. | 2008-11-19 |
| BIOFINITY (COMFILCON A) (P080011) | CooperVision, Inc. | 2008-11-19 |
| ELECSYS TOTAL PSA IMMUNOASSAY AND ELECYS TOTAL PSA CALSET (P990056/S007) | Roche Diagnostics Corp. | 2008-11-18 |
| PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM (P030017/S029) | Boston Scientific Corp | 2008-11-18 |
| 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 |
| MEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM (P980022/S038) | Medtronic Minimed | 2008-11-14 |
| EPIC HF/ATLAS + HF FAMILY OF CRT-DS (P030054/S106) | ABBOTT MEDICAL | 2008-11-14 |
| COAPTITE INJECTABLE IMPLANT (P040047/S009) | Merz North America, Inc. | 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 |
| RADIESSE INJECTABLE IMPLANT (P050037/S013) | Merz North America, Inc. | 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 |
| VITAGEL SURGICAL HEMOSTAT (P050044/S006) | Stryker Corp. | 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 |
| RADIESSE INJECTABLE IMPLANT (P050052/S014) | Merz North America, Inc. | 2008-11-14 |
| ELECSYS HBSAG TEST SYSTEM (P990012/S005) | Roche Diagnostics Corp. | 2008-11-13 |
| DRIVER CORONARY STENT SYSTEMS (P030009/S027) | Medtronic, Ireland | 2008-11-13 |
| VIRTUOSO ICD (P980016/S162) | Medtronic Cardiac Rhythm Disease Management | 2008-11-13 |
| BIRMINGHAM HIP RESURFACING (BHR) SYSTEM (P040033/S006) | Smith & Nephew, Inc. | 2008-11-13 |
| FRONTIER/FRONTIER II FAMILY OF CRT-PS (P030035/S048) | ABBOTT MEDICAL | 2008-11-13 |
| ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S016) | Medtronic, Inc. | 2008-11-13 |
| ELECSYS ANTI-HBS TEST SYSTEM (P010054/S007) | Roche Diagnostics Corp. | 2008-11-13 |
| NOVATION CERAMIC AHS (P050039/S001) | Exactech, Inc. | 2008-11-13 |
| CONCERTO CRT-D (P010031/S129) | Medtronic Cardiac Rhythm Disease Management | 2008-11-13 |
| ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P060033/S019) | Medtronic, Inc. | 2008-11-13 |
| ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S015) | Medtronic, Inc. | 2008-11-13 |
| AFFINITY/IDENTITY/INTEGRITY/VICTORY/ZEPHYR FAMILY OF PACEMAKERS (P880086/S169) | ABBOTT MEDICAL | 2008-11-13 |
| ABBOTT ARCHITECT AUSAB (P050051/S003) | Abbott Laboratories, Inc. | 2008-11-13 |
| COBAS TAQMAN HBV TEST (P050028/S001) | Roche Molecular Systems, Inc. | 2008-11-12 |
| NEUROCYBERNETIC PROSTHESIS (NCP) PROGRAMMING WAND (P970003/S102) | LivaNova USA, Inc. | 2008-11-12 |
| XACT CAROTID STENT SYSTEM (P040038/S013) | Abbott Vascular, Inc. | 2008-11-10 |
| MEDTRONIC SYNCHROMED PUMP AND INFUSION SYSTEM (SYNCHROMED EL AND SYNCHROMED II) (P860004/S090) | Medtronic, Inc. | 2008-11-10 |
| RELIANCE FAMILY ACTIVE FIXATION TACHY LEADS (P910073/S075) | Boston Scientific | 2008-11-07 |
| MAXIMO DR/VR, MARQUIS DR/VR, INTRINSIC ICDS (P980016/S161) | Medtronic Cardiac Rhythm Disease Management | 2008-11-07 |
| APEX MONORAIL AND OVER-THE-WIRE PTCA DILATATION CATHETERS (P860019/S208) | Scimed Life Systems, Inc. | 2008-11-07 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S024) | W. L. Gore & Associates, Inc. | 2008-11-07 |
| NAVISTAR RMT DIAGNOSTIC/ABLATION STEERABLE TIP CATHETER (P990025/S016) | Biosense Webster, Inc. | 2008-11-07 |
| PREPSTAIN SYSTEM (P970018/S014) | Bd Diagnostic Systems | 2008-11-07 |
| ESSURE SYSTEM (P020014/S021) | Bayer Pharma AG | 2008-11-07 |
| NAVISTAR RMT CATHETER FAMILY (P030031/S012) | Biosense Webster, Inc. | 2008-11-07 |
| NAVISTAR RMT DS DIAGNOSTIC/ABLATION STEERABLE TIP CATHETER (P010068/S013) | Biosense Webster, Inc. | 2008-11-07 |
| NAVISTAR RMT THERMOCOOL DIAGNOSTIC/ABLATION STEERABLE TIP CATHETER (P040036/S009) | Biosense Webster, Inc. | 2008-11-07 |
| RADIESSE INJECTABLE IMPLANT (P050037/S012) | Merz North America, Inc. | 2008-11-06 |
| RADIESSE INJECTABLE IMPLANT (P050052/S013) | Merz North America, Inc. | 2008-11-06 |