| EPIC HF/ATLAS+ HF FAMILY OF CRT-DS (P030054/S040) | ABBOTT MEDICAL | 2006-10-20 |
| MAVERICK PTCA CATHETERS (P860019/S215) | Scimed Life Systems, Inc. | 2006-10-20 |
| INSYNC MARQUIS, INSYNC MAXIMO, INSYNC SENTRY AND INSYNC II MARQUIS (P010031/S052) | Medtronic Cardiac Rhythm Disease Management | 2006-10-20 |
| MICRONY FAMILY OF PACEMAKERS PACEMAKER PROGRAMMER MODEL 3330 VERSION 5.0 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE (P970013/S013) | ABBOTT MEDICAL | 2006-10-20 |
| SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS (P880006/S046) | St. Jude Medical, Inc. | 2006-10-20 |
| TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE) (P030025/S013) | Boston Scientific Corp | 2006-10-19 |
| FLEXTOME CUTTING BALLOON MONORAIL (P950020/S019) | Boston Scientific Corp | 2006-10-19 |
| ZENITH AAA ENDOVASCULAR GRAFT WITH H&L-B ONE SHOT INTRODUCTION SYSTEM (P020018/S015) | Cook, Inc. | 2006-10-18 |
| EASYTRAK 3 IS-1 & LV-1 HEART FAILURE LEADS (P010012/S140) | Boston Scientific Corp | 2006-10-17 |
| ZENITH AAA ENDOVASCULAR GRAFT WITH H&L-B ONESHOT INTRODUCTION SYSTEM (P020018/S013) | Cook, Inc. | 2006-10-17 |
| ZENITH AAA ENDOVASCULAR GRAFT WITH H&L-B ONE SHOT INTRODUCTION SYSTEM (P020018/S014) | Cook, Inc. | 2006-10-17 |
| INDENTITY, VERITY, INTEGRITY & VICTORY PACEMAKERS (P880086/S131) | ABBOTT MEDICAL | 2006-10-13 |
| VICTORY PACEMAKERS (P880086/S130) | ABBOTT MEDICAL | 2006-10-13 |
| FRONTIER II CRT-PS (P030035/S021) | ABBOTT MEDICAL | 2006-10-13 |
| MAVERICK PTCA CATHETERS (P860019/S214) | Scimed Life Systems, Inc. | 2006-10-13 |
| FRONTIER II PACEMAKERS (P030035/S022) | ABBOTT MEDICAL | 2006-10-13 |
| ST JUDE MEDICAL IDENTITY, VERITY, INTEGRITY, VICTORY & AFFINITY PACEMAKERS (P880086/S129) | ABBOTT MEDICAL | 2006-10-12 |
| MEDTRONIC SELECTSECURE LEAD MODEL 3830 (P030036/S002) | Medtronic Cardiac Rhythm Disease Management | 2006-10-11 |
| LOCATOR PLUS FAMILY OF DEFLECTABLE STYLETS (P960013/S022) | ABBOTT MEDICAL | 2006-10-10 |
| EXPRESS2 CORONARY STENT SYSTEM (P020009/S030) | Boston Scientific Scimed, Inc. | 2006-10-06 |
| NAVISTAR 4 MM BI-DIRECTIONAL DIAGNOSTIC/ABLATION CATHETERS (P990025/S012) | Biosense Webster, Inc. | 2006-10-06 |
| EPIC II/II + DR/VR AND ATLAS II/II + DR/VR ICDS (P910023/S117) | ABBOTT MEDICAL | 2006-10-06 |
| EPIC II HF & ATLAS II HF CRT-DS (P030054/S037) | ABBOTT MEDICAL | 2006-10-06 |
| TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S036) | Boston Scientific Corp | 2006-10-06 |
| LIBERTE MR & OTW CORONARY STENT SYSTEM (P040016/S017) | Boston Scientific Scimed, Inc. | 2006-10-06 |
| ANGIO-SEAL VASCULAR CLOSURE DEVICE (P930038/S046) | Terumo Medical Corporation | 2006-10-05 |
| THERAPY DUAL CATHETER AND IBI-1500T6 CARDIAC ABLATION GENERATOR (P040042/S005) | Irvine Biomedical,Inc.(Ibi) | 2006-10-03 |
| EXPRESS 2 CORNARY STENT SYSTEM (P020009/S032) | Boston Scientific Scimed, Inc. | 2006-10-03 |
| MAVERICK PTCA CATHETERS (P860019/S213) | Scimed Life Systems, Inc. | 2006-10-03 |
| TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S038) | Boston Scientific Corp | 2006-10-03 |
| RX ACCULINK AND ACCULINK CAROTID STENT SYSTEMS (P040012/S018) | Abbott Vascular | 2006-10-02 |
| ANGIOLINK VASCULAR CLOSURE SYSTEM (P040022/S001) | Medtronic Vascular | 2006-10-02 |
| TAXUS EXPRESS PACLITAXE-ELUTING CORONARY STENT SYSTEM (P030025/S037) | Boston Scientific Corp | 2006-09-29 |
| VARIOUS MODELS OF PACEMAKERS (P880086/S128) | ABBOTT MEDICAL | 2006-09-29 |
| CADENCE, CADET, CONTOUR, ANGSTROM, PROFILE, PHOTON, EPIC, ATLAS, EPIC II, AND ATLAS II ICD FAMILIES (P910023/S118) | ABBOTT MEDICAL | 2006-09-29 |
| EXPRESS 2 CORONARY STENT SYSTEM (P020009/S031) | Boston Scientific Scimed, Inc. | 2006-09-29 |
| MAVERICK PTCA CATHETERS (P860019/S212) | Scimed Life Systems, Inc. | 2006-09-29 |
| STARR EDWARDS SILASTIC BALL PROSTHESIS MODELS 1260 & 6120 (P870038/S008) | Edwards Lifesciences, LLC | 2006-09-29 |
| ST. JUDE MEDICAL EPIC HF, ATLAS + HF, EPIC II HF AND ATLAS II HF CRT-D FAMILIES (P030054/S036) | ABBOTT MEDICAL | 2006-09-29 |
| FRONTIER/FRONTIER II CRT-P (P030035/S020) | ABBOTT MEDICAL | 2006-09-29 |
| CORDIS CYPHER SIROLIMUS ELUTING CORONARY STENT (P020026/S022) | Cordis Corp. | 2006-09-28 |
| STARCLOSE VASCULAR CLOSURE SYSTEM (P050007/S003) | Abbott Vascular Devices | 2006-09-22 |
| RHAPSODY MODELS 2210, 2510 AND 2530 PACEMAKERS; SYMPHONY MODELS 2250 AND 2550 PACEMAKERS (P950029/S029) | MicroPort CRM USA, Inc. | 2006-09-22 |
| CORDIS PRECISE NITINOL STENT SYSTEM (P030047) | Cordis US Corporation | 2006-09-22 |
| EPIC II HF & ATLAS II HF CRT-DS (P030054/S035) | ABBOTT MEDICAL | 2006-09-21 |
| SOLUS, ADDVENT, SOLUS II, SYNCHRONY,PHOENIX III, TRIOLOGY, AFFINITY, INTREGRITY, ENTITY IDENTITY, VERITY AND VICTORY PAC (P880086/S127) | ABBOTT MEDICAL | 2006-09-21 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S011) | W. L. Gore & Associates, Inc. | 2006-09-21 |
| EXPRESS 2 MR & OTW CORONARY STENT SYSTEM (P020009/S028) | Boston Scientific Scimed, Inc. | 2006-09-21 |
| LIBERTE MR & OTW CORONARY STENT SYSTEM (P040016/S015) | Boston Scientific Scimed, Inc. | 2006-09-21 |
| LIBERTE MR & OTW CORONARY STENT SYSTEMS (P040016/S013) | Boston Scientific Scimed, Inc. | 2006-09-21 |
| EPIC II/II + DR/VR & ATLAS II/II + DR/VR ICDS (P910023/S116) | ABBOTT MEDICAL | 2006-09-21 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S015) | W. L. Gore & Associates, Inc. | 2006-09-21 |
| TAXUS EXPRESS 2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S034) | Boston Scientific Corp | 2006-09-21 |
| AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER ? ?CRIBRIFORM? OCCLUDER (P000039/S013) | ABBOTT MEDICAL | 2006-09-21 |
| LIBERTE MR & OTW CORONARY STENT SYSTEM (P040016/S014) | Boston Scientific Scimed, Inc. | 2006-09-21 |
| THERAPY DUAL 8 CATHETER AND IBI-1500T6 CARDIAC ABLATION GENERATOR (P040042/S004) | Irvine Biomedical,Inc.(Ibi) | 2006-09-20 |
| RX ACCULINK & ACCULINK CAROTID STENT SYSTEMS (P040012/S019) | Abbott Vascular | 2006-09-20 |
| SELECTED FAMILIES OF ICDS (P980016/S083) | Medtronic Cardiac Rhythm Disease Management | 2006-09-19 |
| KAPPA 600/700/800/900 & ENPULSE FAMILIES OF PACEMAKERS (P980035/S061) | Medtronic, Inc. | 2006-09-19 |
| VARIOUS INSYNC FAMILIES OF CRT-ICDS (P010031/S050) | Medtronic Cardiac Rhythm Disease Management | 2006-09-19 |
| MODEL 2490H MEDTRONIC CARELINK MONITOR & MODEL 2020A CARDIOSIGHT READER (P890003/S108) | Medtronic, Inc. | 2006-09-19 |
| HOUSECALL PLUS WITH TRANSMITTER SOFTWARE VERSION 3.0, RECEIVER SOFTWARE VERSION 3.0 AND TRANSMITTER HARDWARE VERSION H (P910023/S115) | ABBOTT MEDICAL | 2006-09-18 |
| SYMPHONY 2550 AND 2250 & RHAPSODY 2530, 2510 AND 2210 (P950029/S028) | MicroPort CRM USA, Inc. | 2006-09-15 |
| SYMPHONY & ELA RHAPSODY DEVICES (P950029/S027) | MicroPort CRM USA, Inc. | 2006-09-15 |
| PRIZM FAMILY OF CARDIAC RESYNCHRONIZATION THERAPY DEVICES (CRT-D) (P960040/S125) | Boston Scientific | 2006-09-15 |
| RENEWAL (P010012/S129) | Boston Scientific Corp | 2006-09-15 |
| AMPLATZER DUCT OCCLUDER (P020024/S012) | ABBOTT MEDICAL | 2006-09-15 |
| AMPLATZER SEPTAL OCCLUDER (P000039/S017) | ABBOTT MEDICAL | 2006-09-15 |
| MERIDIAN, MODELS 976,1176, 1276 (P940031/S054) | Boston Scientific | 2006-09-15 |
| MEDTRONIC GEM III AT WITH APP DEVICE MODEL 7276 AND SOFTWARE MODEL9974 (P980050/S024) | Medtronic, Inc. | 2006-09-13 |
| CORDIS CYPHER SIROLIMUS ELUTING CORONARY STENT (P020026/S021) | Cordis Corp. | 2006-09-07 |
| 36 MM DIAMETER ZENITH FLEX AAA ENDOVASCULAR GRAFT (P020018/S010) | Cook, Inc. | 2006-09-07 |
| S.M.A.R.T. CONTROL NITINOL STENT SYSTEM (P020036/S005) | Cordis US Corporation | 2006-09-07 |
| MOSIAC PORCINE BIOPROSTHESIS, MODELS 305, 310 (P990064/S016) | Medtronic, Inc. | 2006-09-01 |
| FREESTYLE AORTIC ROOT BIOPROSTHESIS, MODELS 995, 995MS AND 995CS (P970031/S017) | Medtronic, Inc. | 2006-09-01 |
| RX ACCULINK AND ACCULINK CAROTID STENT SYSTEMS (P040012/S023) | Abbott Vascular | 2006-09-01 |
| HANCOCK II PORCINE BIOPROSTHESIS, MODELS T505 AND T510 (P980043/S010) | Medtronic, Inc. | 2006-09-01 |
| KAPPA 400 SERIES (P970012/S024) | Medtronic, Inc. | 2006-08-31 |
| INSYNC 8040 DEVICE, INSYNC III 8042.8044 DEVICES (P010015/S024) | Medtronic, Inc. | 2006-08-31 |
| MEDTRONIC CARELINK MONITOR MODEL 2490C AND MODEL 2491 DDMA DEVICES (P890003/S102) | Medtronic, Inc. | 2006-08-31 |
| VIRTUOSO MODELS D154AWG/ D154VWC IMPLANTABLE DEVICES (P010031/S048) | Medtronic Cardiac Rhythm Disease Management | 2006-08-31 |
| CONCERTO MODEL C154DWK (P010031/S040) | Medtronic Cardiac Rhythm Disease Management | 2006-08-31 |
| MEDTRONIC CARELINK MONITOR MODEL 2490C AND MODEL 2491 DMA SOFTWARE (P980016/S073) | Medtronic Cardiac Rhythm Disease Management | 2006-08-31 |
| KAPPA 600/650/700 , KAPPA 800/900 MODELS (P980035/S059) | Medtronic, Inc. | 2006-08-31 |
| THERA/THERA-I PRODIGY SERIES (P890003/S107) | Medtronic, Inc. | 2006-08-31 |
| CONCERTO MODEL C154DWK IMPLANTABLE DEVICES (P980016/S081) | Medtronic Cardiac Rhythm Disease Management | 2006-08-31 |
| VARIOUS FAMILIES OF PACEMAKERS (P890003/S098) | Medtronic, Inc. | 2006-08-30 |
| VARIOUS FAMILIES OF PACEMAKERS (P820003/S077) | Medtronic Cardiac Rhythm Disease Management | 2006-08-30 |
| EZ STEER AND EZ STEER DS BIDIRECTIONAL DIAGNOSTIC/ABLATION CATHETERS (P950005/S019) | Biosense Webster, Inc. | 2006-08-29 |
| NAVISTAR DS BI-DIRECTIONAL DIAGNOSTIC/ABLATION CATHETER (P010068/S006) | Biosense Webster, Inc. | 2006-08-29 |
| FREESTYLE AORTIC ROOT BIOPROTHESIS MODEL 995 (P970031/S015) | Medtronic, Inc. | 2006-08-28 |
| CONTAK TR CARDIAC RESYNCHRONIZATION THERAPY SYSTEMS (P030005/S035) | Guidant Corp. | 2006-08-25 |
| PRIZM, PRIZM HE, PRIZM 2, VITALITY, VITALITY 2, VITALITY AVT, VITALITY DS, VITALITY EL, VITALITY HE (P960040/S127) | Boston Scientific | 2006-08-25 |
| MOSAIC PORCINE BIOPROSTHESIS (P990064/S015) | Medtronic, Inc. | 2006-08-25 |
| CONTAK RENEWAL, CONTAK RENEWAL 3, CONTAK RENEWAL 3 RF CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR SYSTEMS (P010012/S131) | Boston Scientific Corp | 2006-08-25 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S025) | Cordis Corp. | 2006-08-25 |
| DISCOVERY/ MERIDIAN (P940031/S055) | Boston Scientific | 2006-08-25 |
| MEDTRONIC CARELINK MONITOR MODEL 2490H VERSION A07801 REVISION C (P980035/S058) | Medtronic, Inc. | 2006-08-24 |
| MEDTRONIC CARELINK MONITOR MODEL 2490H VERSION A07801 REVISION C (P890003/S106) | Medtronic, Inc. | 2006-08-24 |
| FLEXTOME CUTTING BALLOON MONORAIL DEVICE (P950020/S018) | Boston Scientific Corp | 2006-08-22 |