| SJM EPIC VALVE AND SJM EPIC SUPRA VALVE (P040021/S004) | ABBOTT MEDICAL | 2007-11-15 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S031) | W. L. Gore & Associates, Inc. | 2007-11-15 |
| NAVISTAR CATHETERS (P040036/S005) | Biosense Webster, Inc. | 2007-11-14 |
| LATITUDE INDUCTIVE PATIENT MANAGEMENT COMMUNICATOR (P910077/S080) | Boston Scientific | 2007-11-14 |
| CONTAK RENEWAL FAMILY (P010012/S159) | Boston Scientific Corp | 2007-11-14 |
| THORATEC TLC-II PORTABLE VAD DRIVER (P870072/S037) | Thoratec Laboratories Corp. | 2007-11-14 |
| PRIZM, PRIZM AT & VITALITY FAMILIES (P960040/S151) | Boston Scientific | 2007-11-14 |
| NAVISTAR & CELSIUS CATHETERS (P030031/S008) | Biosense Webster, Inc. | 2007-11-14 |
| MYNX VASCULAR CLOSURE DEVICE (P040044/S003) | Cordis US Corporation | 2007-11-14 |
| ALL IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (P980049/S028) | MicroPort CRM USA, Inc. | 2007-11-13 |
| ALL RATE RESPONSIVE IMPLANTABLE PACEMAKERS (P950029/S031) | MicroPort CRM USA, Inc. | 2007-11-13 |
| ALL NON-RATE RESPONSIVE PACEMAKERS (P900022/S009) | MicroPort CRM USA, Inc. | 2007-11-13 |
| PRODIGY/THERA-I PACEMAKERS (P890003/S128) | Medtronic, Inc. | 2007-11-09 |
| ZILVER VASCULAR STENT (P050017/S001) | Cook Ireland, Ltd. | 2007-11-09 |
| CARDIOMESSENGER II (P950037/S054) | Biotronik, Inc. | 2007-11-09 |
| MEDTRONIC CARELINK MONITOR (P890003/S127) | Medtronic, Inc. | 2007-11-09 |
| VARIOUS FAMILIES OF PACEMAKERS (P990001/S032) | Medtronic, Inc. | 2007-11-09 |
| KAPPA 400 DR IPG & KAPPA 400 SR IPG PACEMAKERS (P970012/S029) | Medtronic, Inc. | 2007-11-09 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S026) | W. L. Gore & Associates, Inc. | 2007-11-09 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S030) | W. L. Gore & Associates, Inc. | 2007-11-09 |
| EASYTRAK 2 FAMILY OF LEADS (P010012/S152) | Boston Scientific Corp | 2007-11-09 |
| INSYNC CRT-P & INSYNC III CRT-P (P010015/S033) | Medtronic, Inc. | 2007-11-09 |
| MARQUIS, MAXIMO AND EN TRUST DEVICE (P980016/S110) | Medtronic Cardiac Rhythm Disease Management | 2007-11-09 |
| CARDIOMESSENGER TLINE (P000009/S023) | Biotronik, Inc. | 2007-11-09 |
| CARDIOMESSENGER (CM LLT, CM T LINE AND CM II) (P050023/S007) | Biotronik, Inc. | 2007-11-09 |
| INSYNC MARQUIS, INSYNC SENTRY, AND INSYNC MAXIMO FAMILIES (P010031/S080) | Medtronic Cardiac Rhythm Disease Management | 2007-11-09 |
| VARIOUS FAMILIES OF PACEMAKERS (P980035/S078) | Medtronic, Inc. | 2007-11-09 |
| CORDIS PRECISE NITINOL STENT SYSTEM (P030047/S007) | Cordis US Corporation | 2007-11-08 |
| MICRONY FAMILY OF PACEMAKERS/PACEMAKER PROGRAMMER (P970013/S020) | ABBOTT MEDICAL | 2007-11-06 |
| PRIZM & VITALITY FAMILIES (P960040/S150) | Boston Scientific | 2007-11-06 |
| FRONTIER/FRONTIER II FAMILY OF CRT-PS (P030035/S034) | ABBOTT MEDICAL | 2007-11-06 |
| EPIC HF/ATLAS+ FAMILY OF CRT-DS (P030054/S070) | ABBOTT MEDICAL | 2007-11-06 |
| RENEWAL 3 RF FAMILIES (P010012/S157) | Boston Scientific Corp | 2007-11-06 |
| SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS (P880006/S053) | St. Jude Medical, Inc. | 2007-11-06 |
| CADENCE FAMILY OF ICDS (P910023/S157) | ABBOTT MEDICAL | 2007-11-06 |
| LATITUDE COMMUNICATOR SOFTWARE & SYSTEM SOFTWARE (P910077/S077) | Boston Scientific | 2007-11-06 |
| AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS (P880086/S151) | ABBOTT MEDICAL | 2007-11-06 |
| TMR2000 HOLMIUM LASER SYSTEM (P970029/S011) | Cryolife, Inc. | 2007-11-05 |
| PASSIVE FIXATION FAMILY OF LEADS (P880086/S154) | ABBOTT MEDICAL | 2007-10-31 |
| LIFEVEST WCD 3000 (P010030/S008) | Zoll Manufacturing Corporation | 2007-10-31 |
| CARDIOVASCULAR PERMANENT PACEMAKERS (P960030/S018) | ABBOTT MEDICAL | 2007-10-31 |
| ACTIVE FIXATION FAMILY OF LEADS (P960013/S034) | ABBOTT MEDICAL | 2007-10-31 |
| LEFT VENTRICULAR FAMILY OF LEADS (P030035/S035) | ABBOTT MEDICAL | 2007-10-31 |
| LEFT VENTRICULAR FAMILY OF LEADS (P030054/S071) | ABBOTT MEDICAL | 2007-10-31 |
| MULTI-LINK VISION RX ZETA CORONARY STENT SYSTEMS (P970020/S050) | Abbott Vascular, Inc. | 2007-10-29 |
| QUIKSTAR FAMILY OF CATHETERS (P990025/S014) | Biosense Webster, Inc. | 2007-10-29 |
| CELSIUS & EZ STEER FAMILIES OF CATHETERS (P950005/S023) | Biosense Webster, Inc. | 2007-10-29 |
| NAVISTAR FAMILY OF CATHETERS (P040036/S004) | Biosense Webster, Inc. | 2007-10-29 |
| NAVISTAR & CELSIUS FAMILIES OF CATHETERS (P030031/S007) | Biosense Webster, Inc. | 2007-10-29 |
| CONTACT RENEWAL (P010012/S162) | Boston Scientific Corp | 2007-10-29 |
| FRONTIER & FRONTIER II CRT-PS (P030035/S033) | ABBOTT MEDICAL | 2007-10-29 |
| PRIZM2/VITALITY (P960040/S153) | Boston Scientific | 2007-10-29 |
| IDENTITY,VERITY,INTEGRITY,VICTORY,ZEPHYR PACEMAKERS (P880086/S149) | ABBOTT MEDICAL | 2007-10-29 |
| MULTI-LINK VISION RX FAMILY OF CORONARY STENT SYSTEMS (P020047/S011) | Abbott Vascular | 2007-10-29 |
| NAVISTAR & EZ STEER FAMILIES OF CATHETERS (P010068/S011) | Biosense Webster, Inc. | 2007-10-29 |
| MODEL 8005 PUMP SYSTEM (CIRCUCOOL PUMP), MODEL M00480050 (P980003/S020) | Boston Scientific Corp | 2007-10-29 |
| IDENTITY,INTEGRITY,VERITY,VICTORY & ZEPHYR PACEMAKERS (P880086/S153) | ABBOTT MEDICAL | 2007-10-26 |
| CONTAK RENEWAL TR (P030005/S047) | Guidant Corp. | 2007-10-26 |
| MULTI-LINK VISION CORONARY STENT SYSTEM AND MULTI-LINK MINI VISION CORONARY STENT SYSTEM (P020047/S010) | Abbott Vascular | 2007-10-26 |
| ANEURX AAADVANTAGE STONE GRAFT WITH XCELERANT DELIVERY SYSTEM (P990020/S027) | Medtronic Vascular | 2007-10-26 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S039) | Cordis Corp. | 2007-10-26 |
| PASSIVE PLUS DX FAMILY OF LEADS (P960030/S017) | ABBOTT MEDICAL | 2007-10-24 |
| PASSIVE PLUS DX FAMILY OF LEADS (P880086/S152) | ABBOTT MEDICAL | 2007-10-24 |
| MULTI-LINK ZETA RX CORONARY STENT SYSTEM (P970020/S049) | Abbott Vascular, Inc. | 2007-10-24 |
| VARIOUS FAMILIES OF PACEMAKERS & 3510 PROGRAMMER (P830045/S110) | St. Jude Medical, Inc. | 2007-10-24 |
| VARIOUS FAMILIES OF ICDS & MERLIN PROGRAMMER (P910023/S158) | ABBOTT MEDICAL | 2007-10-24 |
| EXPONENT SELF-EXPANDING CAROTID STENT SYSTEM WITH OVER-THE-WIRE OR RAPID-EXCHANGE DELIVERY SYSTEM (P070012) | Medtronic Vascular | 2007-10-23 |
| OVATIO DR MODEL 6550 AND OVATIO VR MODEL 6260 (P980049/S027) | MicroPort CRM USA, Inc. | 2007-10-23 |
| MITROFLOW AORTIC PERICARDIAL HEART VALVE (P060038) | Corcym Canada Corp | 2007-10-23 |
| MODEL 3120 ZOOM PROGRAMMER SYSTEM (P910077/S079) | Boston Scientific | 2007-10-19 |
| SAFIRE TX CATHETER (P040042/S011) | Irvine Biomedical,Inc.(Ibi) | 2007-10-19 |
| EPIC HF/ATLAS+HF CRT-D FAMILY OF DEVICES (P030054/S069) | ABBOTT MEDICAL | 2007-10-19 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S029) | W. L. Gore & Associates, Inc. | 2007-10-19 |
| CADENCE FAMILY OF DEVICES (P910023/S156) | ABBOTT MEDICAL | 2007-10-19 |
| RIATA FAMILY OF LEADS (P950022/S043) | ABBOTT MEDICAL | 2007-10-19 |
| ZOOM LATITUDE PROGRAMMING SYSTEM (P910077/S078) | Boston Scientific | 2007-10-18 |
| HANCOCK MODIFIED ORIFICE (MO) VALVED CONDUIT (P980043/S013) | Medtronic, Inc. | 2007-10-18 |
| PRIZM, VITALITY AND CONTAK RENEWAL FAMILIES OF DEVICES (P960040/S146) | Boston Scientific | 2007-10-18 |
| BIOGLUE SURGICAL ADHESIVE (P010003/S011) | Cryolife, Inc. | 2007-10-18 |
| FREESTYLE AORTIC ROOT BIOPROSTHESIS (P970031/S020) | Medtronic, Inc. | 2007-10-18 |
| CONTAK RENEWAL FAMILY (P010012/S153) | Boston Scientific Corp | 2007-10-18 |
| ANGIOSCULPT SCORING BALLOON CATHETER (P050018/S003) | Spectranetics Corp. | 2007-10-18 |
| MOSAIC PORCINE BIOPROSTHESIS (P990064/S020) | Medtronic, Inc. | 2007-10-18 |
| HANCOCK MODIFIED ORIFICE (MO) VALVED CONDUIT (P790007/S020) | Medtronic Heart Valves | 2007-10-18 |
| CORDIS CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S042) | Cordis Corp. | 2007-10-16 |
| TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S047) | Boston Scientific Corp | 2007-10-16 |
| MEDTRONIC CARELINK MONITOR PROGRAMMER MODEL 2090 (P890003/S123) | Medtronic, Inc. | 2007-10-16 |
| RIATA ST OPTIM LEADS AND RIATA STS OPTIM LEADS AND (P950022/S041) | ABBOTT MEDICAL | 2007-10-16 |
| EPIC HF CRT-DS (P030054/S068) | ABBOTT MEDICAL | 2007-10-12 |
| CADENCE ICDS (P910023/S155) | ABBOTT MEDICAL | 2007-10-12 |
| AMPLATZER SEPTAL OCCLUDER & MULTI-FENESTRATED SEPTAL OCCLUDER (P000039/S022) | ABBOTT MEDICAL | 2007-10-05 |
| EPIC HF/ATLAS+HF FAMILY OF CRT-DS (P030054/S064) | ABBOTT MEDICAL | 2007-10-05 |
| AMPLATZER DUCT OCCLUDER (P020024/S016) | ABBOTT MEDICAL | 2007-10-05 |
| WALLSTENT ILIAC ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P940019/S021) | Boston Scientific Scimed, Inc. | 2007-10-05 |
| CADENCE FAMILY OF ICDS (P910023/S151) | ABBOTT MEDICAL | 2007-10-05 |
| CARELINK PROGRAMMER, MODEL 2090 (P890003/S125) | Medtronic, Inc. | 2007-10-04 |
| INSYNC SENTRY & MAXIMO USED WITH SOFTWARE APPLICATION, MODELS 7297 AND 7299 (P010031/S076) | Medtronic Cardiac Rhythm Disease Management | 2007-10-04 |
| ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S090) | Boston Scientific Corp | 2007-10-03 |
| CONTRAK CD/EASYTRAK (P010012/S156) | Boston Scientific Corp | 2007-09-28 |
| CADENCE ICD'S (P910023/S153) | ABBOTT MEDICAL | 2007-09-28 |