| CRT-D'S (P030054/S066) | ABBOTT MEDICAL | 2007-09-28 |
| VENTAK AV/VR (VENTAK PRIZM) (P960040/S149) | Boston Scientific | 2007-09-28 |
| MODELS 5348 AND 5388 EXTERNAL PULSE GENERATORS (P820003/S081) | Medtronic Cardiac Rhythm Disease Management | 2007-09-28 |
| VOYAGER OTW CORONARY DILATATION CATHETER (P810046/S222) | Advanced Cardiovascular Systems, Inc. | 2007-09-27 |
| ZENITH AAA ENDOVASCULAR GRAFT WITH H&L ONE SHOT INTRODUCTION SYSTEM (P020018/S022) | Cook, Inc. | 2007-09-25 |
| SAFIRE CARDIAC ABLATION SYSTEM (P960016/S019) | St Jude Medical | 2007-09-24 |
| CADENCE FAMILY OF ICD'S (P910023/S152) | ABBOTT MEDICAL | 2007-09-21 |
| VIRTUOSO (P980016/S107) | Medtronic Cardiac Rhythm Disease Management | 2007-09-21 |
| CONCERTO CARDIAC RESYNCHRONIZATION THERAPY DEVICES (CRT-DS) (P010031/S077) | Medtronic Cardiac Rhythm Disease Management | 2007-09-21 |
| GORE HELEX SEPTAL OCCLUDER (P050006/S001) | W. L. Gore & Associates, Inc. | 2007-09-21 |
| CORDIS CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S041) | Cordis Corp. | 2007-09-21 |
| RESPONSE CV CARDIOVERSION ELECTROPHYSIOLOGY CATHETER (P020052/S004) | St Jude Medical | 2007-09-21 |
| RESPONSE CV CARDIOVERSION ELECTROPHYSIOLOGY CATHETER (P020052/S003) | St Jude Medical | 2007-09-21 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S006) | W. L. Gore & Associates, Inc. | 2007-09-21 |
| EPIC HF FAMILY OF CRT-D'S (P030054/S065) | ABBOTT MEDICAL | 2007-09-21 |
| MYNX VASCULAR CLOSURE DEVICE (P040044/S002) | Cordis US Corporation | 2007-09-20 |
| CORDIS S.M.A.R.T. NITINOL STENT SYSTEM & S.M.A.R.T. CONTROL NITINOL STENT SYSTEM (P020036/S008) | Cordis US Corporation | 2007-09-20 |
| CORDIS PRECISE NITINOL & RX NITINOL & PRO RX NITINOL STENT SYSTEM (P030047/S005) | Cordis US Corporation | 2007-09-20 |
| PRIZM, PRIZM II CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-D) (P960040/S143) | Boston Scientific | 2007-09-19 |
| VOYAGER RX CORONARY DILATATION CATHETER (P810046/S223) | Advanced Cardiovascular Systems, Inc. | 2007-09-19 |
| VOYAGER OTW CORONARY DILATATION CATHETER (P810046/S224) | Advanced Cardiovascular Systems, Inc. | 2007-09-19 |
| KAPPA 900 (P980035/S075) | Medtronic, Inc. | 2007-09-18 |
| INSYNC III (P010015/S031) | Medtronic, Inc. | 2007-09-18 |
| KAPPA 400 (P970012/S028) | Medtronic, Inc. | 2007-09-18 |
| THERA/PRODIGY (P890003/S124) | Medtronic, Inc. | 2007-09-18 |
| CARELINK MONITOR MODELS 2490G, 2490H, 2490J, AND THE 2020A CARDIOSIGHT READER (P900061/S071) | Medtronic Cardiac Rhythm Disease Management | 2007-09-14 |
| KAPPA, ENPULSE & ADAPTA PACEMAKERS (P980035/S069) | Medtronic, Inc. | 2007-09-14 |
| MARQUIS, MAXIMO & ENTRUST ICDS (P980016/S092) | Medtronic Cardiac Rhythm Disease Management | 2007-09-14 |
| VARIOUS PACEMAKERS, CARELINK MONITORS, CARDIOSIGHT READER (P890003/S114) | Medtronic, Inc. | 2007-09-14 |
| INSYNC MARQUIS, SENTRY, MAXIMO CRT-ICDS (P010031/S059) | Medtronic Cardiac Rhythm Disease Management | 2007-09-14 |
| MEDTRONIC ICD MODEL INSYNC 7272 SYSTEM (P010031/S073) | Medtronic Cardiac Rhythm Disease Management | 2007-09-13 |
| VIRTUOSO (P980016/S105) | Medtronic Cardiac Rhythm Disease Management | 2007-09-12 |
| CONCERTO (P010031/S074) | Medtronic Cardiac Rhythm Disease Management | 2007-09-12 |
| CONCERTO CARDIAC RESYNCHRONIZATION THERAPY DEVICES (CRT-DS) (P010031/S075) | Medtronic Cardiac Rhythm Disease Management | 2007-09-12 |
| VIRTUOSO FAMILY OF DEVICES (P980016/S106) | Medtronic Cardiac Rhythm Disease Management | 2007-09-12 |
| MODEL 2490G/H/J MEDTRONIC CARELINK MONITOR AND THE MODEL 2020A CARDIOSIGHT READER (P900061/S073) | Medtronic Cardiac Rhythm Disease Management | 2007-09-11 |
| VARIOUS FAMILIES OF PACEMAKERS (P890003/S126) | Medtronic, Inc. | 2007-09-11 |
| CURRENT ICD'S (P030054/S050) | ABBOTT MEDICAL | 2007-09-11 |
| VARIOUS FAMILIES OF ICDS (P980016/S108) | Medtronic Cardiac Rhythm Disease Management | 2007-09-11 |
| INSYNC FAMILY & CONCERTO CRT-ICDS (P010031/S078) | Medtronic Cardiac Rhythm Disease Management | 2007-09-11 |
| VARIOUS FAMILIES OF PACEMAKERS (P980035/S076) | Medtronic, Inc. | 2007-09-11 |
| PROMOTE MODELS 3207-36 AND 3207-30 (P910023/S132) | ABBOTT MEDICAL | 2007-09-11 |
| AMPLATZER MUSCULAR VSD OCCLUDER (P040040) | ABBOTT MEDICAL | 2007-09-07 |
| RIATA STS OPTIM LEAD MODELS 7120, 7121,7122,7130 AND 7131 (P950022/S040) | ABBOTT MEDICAL | 2007-09-06 |
| CYPHER SIROLIMUS ELUTING CORONARY STENT (P020026/S040) | Cordis Corp. | 2007-09-04 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S027) | W. L. Gore & Associates, Inc. | 2007-09-04 |
| PHILOS AND AXIOS FAMILY OF PULSE GENERATORS (P950037/S051) | Biotronik, Inc. | 2007-08-31 |
| FIRE STAR RX PTCA BALLOON DILATATION CATHETER (P880003/S090) | Cordis Corp. | 2007-08-31 |
| MICRO-DRIVER CORONARY STENT SYSTEM (MX2 & OTW) (P030009/S014) | Medtronic, Ireland | 2007-08-30 |
| ZENITH AAA ENDOVASCULAR GRAFT WITH H&L-B ONE SHOT INTRODUCTION SYSTEM (P020018/S016) | Cook, Inc. | 2007-08-30 |
| GRUNTZIG DILACA CORONARY ARTERY BALLOON DILATATION CATHETER (NC STORMER OTW & NC STORMER MX2) (P790017/S092) | Medtronic, Ireland | 2007-08-30 |
| S-SERIES CORONARY STENT SYSTEMS (P970035/S047) | Medtronic, Ireland | 2007-08-30 |
| DRIVER CORONARY STENT SYSTEMS (P030009/S015) | Medtronic, Ireland | 2007-08-30 |
| GRUNTZIG DILACA CORONARY ARTERY BALLOON DILATION CATHETER, NC STORMER MX2 (P790017/S091) | Medtronic, Ireland | 2007-08-30 |
| HANCOCK II BIOPROSTHESIS (P980043/S012) | Medtronic, Inc. | 2007-08-29 |
| MOSAIC PORCINE BIOPROSTHESIS (P990064/S018) | Medtronic, Inc. | 2007-08-29 |
| DURA STAR RX PTCA BALLOON DILATATION CATHETER (P880003/S089) | Cordis Corp. | 2007-08-29 |
| SPRINTER OVER THE WIRE (OTW) & SPRINTER MULTI-EXCHANGE (MX2) BALLOON DILATATION CATHETER (P790017/S088) | Medtronic, Ireland | 2007-08-29 |
| DRIVER RAPID EXCHANGE (RX) CORONARY STENT SYSTEMS (P030009/S009) | Medtronic, Ireland | 2007-08-29 |
| NEXSTENT CAROTID STENT AND MONORAIL DELIVERY SYSTEM (P050025/S006) | Boston Scientific | 2007-08-24 |
| CONTAK RENEW 3 RF (P010012/S151) | Boston Scientific Corp | 2007-08-24 |
| CELSIUS,CELSIUS II, CELSIUS RMT, EZ STEER, EZ STEER DS DIAGNOSTIC/ABLATION CATHETERS (P950005/S021) | Biosense Webster, Inc. | 2007-08-23 |
| NAVISTAR RMT DS CATHETER (P010068/S010) | Biosense Webster, Inc. | 2007-08-23 |
| NAVISTAR 4 MM BI DIRECTIONAL DIAGNOSTIC/ABLATION CATHETER (P990025/S013) | Biosense Webster, Inc. | 2007-08-23 |
| SPRINTER OVER-THE-WIRE BALLOON DILATATION CATHETER (P790017/S087) | Medtronic, Ireland | 2007-08-22 |
| TENDRIL FAMILY OF LEADS (P960013/S030) | ABBOTT MEDICAL | 2007-08-21 |
| SAFIRE TX CARDIAC ABLATION CATHETER AND INTERFACE CABLES (P040042/S009) | Irvine Biomedical,Inc.(Ibi) | 2007-08-21 |
| FEMORAL INTRODUCER SHEATH AND HEMOSTASIS (FISH) DEVICE 5,6, AND 8 FRENCH (P050043) | Morris Innovative Research, Inc. | 2007-08-20 |
| CADENCE ICDS (P910023/S145) | ABBOTT MEDICAL | 2007-08-17 |
| EPIC HF CRT-DS (P030054/S060) | ABBOTT MEDICAL | 2007-08-17 |
| GRUNTZIG DILACA CORONARY ARTERY BALLOON DILATATION CATHETER (P790017/S086) | Medtronic, Ireland | 2007-08-17 |
| EPIC HF CRT-DS (P030054/S062) | ABBOTT MEDICAL | 2007-08-17 |
| LIFEVEST WCD 3000 (P010030/S009) | Zoll Manufacturing Corporation | 2007-08-17 |
| CADENCE ICDS (P910023/S146) | ABBOTT MEDICAL | 2007-08-17 |
| NEXSTENT STENT AND MONORAIL DELIVERY SYSTEM (P050025/S005) | Boston Scientific | 2007-08-17 |
| EPIC HF CRT-DS (P030054/S061) | ABBOTT MEDICAL | 2007-08-17 |
| CADENCE ICDS (P910023/S144) | ABBOTT MEDICAL | 2007-08-17 |
| AMPLATZER SEPTAL OCCLUDER (P000039/S019) | ABBOTT MEDICAL | 2007-08-16 |
| ATS OPEN PIVOT BILEAFLET HEART VALVES (P990046/S013) | Medtronic Ats Medical, Inc. | 2007-08-16 |
| RELIANCE ACTIVE FIX & RELIANCE PASSIVE FIX STERIOD ELUTING ENDOCARDIAL DEFIBRILLATION LEADS (P910073/S067) | Boston Scientific | 2007-08-15 |
| MODEL 5388 EXTERNAL PULSE GENERATOR (P820003/S080) | Medtronic Cardiac Rhythm Disease Management | 2007-08-10 |
| CONTAK RENEWAL TR (P030005/S044) | Guidant Corp. | 2007-08-10 |
| ENTRUST 30J & 35J ICD & VIRTUOSO DR & VR ICD (P980016/S104) | Medtronic Cardiac Rhythm Disease Management | 2007-08-10 |
| CONCERTO CRT-D (P010031/S072) | Medtronic Cardiac Rhythm Disease Management | 2007-08-10 |
| MEDTRONIC ENTRUST 35J ICD (D154ATG, D15DRG. D154VRC) MEDTRONIC VIRTUOSO ICD (D154AWG, D154VWC) (P980016/S099) | Medtronic Cardiac Rhythm Disease Management | 2007-08-07 |
| CONCERTO (C154DWK) (P010031/S067) | Medtronic Cardiac Rhythm Disease Management | 2007-08-07 |
| VENTAK PRX/MINI ICD SYSTEM (P910077/S053) | Boston Scientific | 2007-08-06 |
| RENEWAL TR (P030005/S022) | Guidant Corp. | 2007-08-06 |
| CONTAK RENEWAL CD (P010012/S078) | Boston Scientific Corp | 2007-08-06 |
| TENDRIL FAMILY OF LEADS (P960013/S029) | ABBOTT MEDICAL | 2007-08-06 |
| PRIZM/ VITALITY (P960040/S088) | Boston Scientific | 2007-08-06 |
| DISCOVERY/MERIDIAN (P940031/S046) | Boston Scientific | 2007-08-06 |
| LATITUDE PATIENT MANAGEMENT SYSTEM MODEL 6481 INDUCTIVE COMMUNICATOR (P910077/S075) | Boston Scientific | 2007-08-03 |
| PROTEGE GPS AND PROTEGE RX CAROTID STENT SYSTEM (P060001/S003) | Medtronic Vascular, Inc. | 2007-08-02 |
| ANGIOJET RHELYTIC THROMBECTOMY SYSTEM (P980037/S023) | Boston Scientific Corp | 2007-08-02 |
| AMPLATZER SEPTAL OCCLUDER (P000039/S021) | ABBOTT MEDICAL | 2007-08-02 |
| CRYOCOR CRYOABLATION SYSTEM (P050024) | Boston Scientific Corp | 2007-08-01 |
| GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE S4URFACE (P040037/S004) | W. L. Gore & Associates, Inc. | 2007-07-31 |
| STARCLOSE & STARCLOSE SE VASCULAR CLOSURE SYSTEM (P050007/S006) | Abbott Vascular Devices | 2007-07-30 |
| CAPSURE SP & CAPSURE Z (P850089/S056) | Medtronic Cardiac Rhythm Disease Management | 2007-07-27 |