| OVATIO VR/DR (P980049/S045) | MicroPort CRM USA, Inc. | 2009-02-23 |
| SYMPHONY SR 2250, SYMPHONY DR 2550, RHAPSODY SR 2210, RHAPSODY DR 2510, RHAPSODY DR 2530, REPLY ST & REPLY DR PACEMAKERS (P950029/S040) | MicroPort CRM USA, Inc. | 2009-02-23 |
| CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE MITRAL BIOPROSTHESES, MODELS 7100 AND 7100TFX (P860057/S054) | Edwards Lifesciences, LLC | 2009-02-20 |
| POWERLINK SYSTEM (P040002/S023) | Endologix, LLC | 2009-02-20 |
| NAVISTAR RMT THERMOCOOL DIAGNOSTIC / ABLATION STEERABLE TIP CATHETER (P040036/S008) | Biosense Webster, Inc. | 2009-02-20 |
| NAVISTAR RMT THERMOCOOL DIAGNOSTIC / ABLATION STEERABLE TIP CATHETER (P030031/S010) | Biosense Webster, Inc. | 2009-02-20 |
| ATS 3F AORTIC BIOPROSTHESIS (P060025/S004) | Medtronic, Inc. | 2009-02-19 |
| MAVERICK OTW/MAVERICK 2 MONORAIL PERCUTANEOUS CORONARY ANGIOPLASTY (PTCA) CATHETER (P860019/S231) | Scimed Life Systems, Inc. | 2009-02-19 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S042) | W. L. Gore & Associates, Inc. | 2009-02-18 |
| ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S095) | Boston Scientific Corp | 2009-02-17 |
| ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM & SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S014) | Medtronic, Inc. | 2009-02-17 |
| ENTRUST DR/VR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P980016/S173) | Medtronic Cardiac Rhythm Disease Management | 2009-02-13 |
| GORE HELEX SEPTAL OCCLUDER (P050006/S010) | W. L. Gore & Associates, Inc. | 2009-02-13 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S043) | W. L. Gore & Associates, Inc. | 2009-02-13 |
| RENEWAL, RENEWAL RF, RENEWAL ZODIAC, FRONTIER AND LIVIAN (P010012/S200) | Boston Scientific Corp | 2009-02-13 |
| CONFIENT, FRONTIER, AND VITALITY (P960040/S187) | Boston Scientific | 2009-02-13 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S027) | W. L. Gore & Associates, Inc. | 2009-02-13 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S016) | W. L. Gore & Associates, Inc. | 2009-02-13 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S013) | W. L. Gore & Associates, Inc. | 2009-02-13 |
| LIFESTENT FLEXSTAR & FLEXSTAR XL VASCULAR STENT SYSTEM (P070014) | Bard Peripheral Vascular, Inc. | 2009-02-13 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S011) | Abbott Vascular, Inc. | 2009-02-11 |
| MODEL 5441 EPG PLASTIC COVER (P820003/S088) | Medtronic Cardiac Rhythm Disease Management | 2009-02-11 |
| ENTRUST/VIRTUOSO/VIRTUOSO II/MAXIMO/MAXIMO II/SECURA/MARQUIS/INSTRINSIC 35J ICDS (P980016/S174) | Medtronic Cardiac Rhythm Disease Management | 2009-02-10 |
| MAXIMO II CRT-D/CONCERTO ICD/CONSULTA CRT-D/INSYNC III MARQUIS/PROTECT/INSYNC SENTRY ICD/CONCERTO II CRT-D (P010031/S140) | Medtronic Cardiac Rhythm Disease Management | 2009-02-10 |
| NAVISTAR & CELSIUS THERMOCOOL CATHETERS (P030031/S011) | Biosense Webster, Inc. | 2009-02-06 |
| NAVISTAR THERMOCOOL AND CELSIUS THERMOCOOL DEFLECTABLE DIAGNOSTIC / ABLATION CATHETERS (P040036/S007) | Biosense Webster, Inc. | 2009-02-05 |
| REPLY PACER EMBEDDED SOFTWARE W1.5.1 AND ASSOCIATED PROGRAMMER APPLICATION SOFTWARE VERSION SMARTVIEW 2.10 UG1 (P900022/S012) | MicroPort CRM USA, Inc. | 2009-02-04 |
| SITUS OTW UW28D LEFT VENTRICULAR PACING LEAD (P060027/S008) | MicroPort CRM USA, Inc. | 2009-02-04 |
| AMPLATZER MUSCULAR VSD OCCLUDER (P040040/S006) | ABBOTT MEDICAL | 2009-02-04 |
| EPIC HF/ATLAS + HF FAMILY OF CRT-DS (P030054/S113) | ABBOTT MEDICAL | 2009-02-04 |
| ISOLINE 2CR/2CT DEFIBRILLATION LEADS (P980049/S044) | MicroPort CRM USA, Inc. | 2009-02-04 |
| CADENCE FAMILY OF ICDS (P910023/S199) | ABBOTT MEDICAL | 2009-02-04 |
| SYMPHONY SR/DR & RHAPSODY SR/DR (P950029/S039) | MicroPort CRM USA, Inc. | 2009-02-04 |
| VARIOUS FAMILIES OF PACEMAKERS (P980035/S114) | Medtronic, Inc. | 2009-02-04 |
| OVATIO CRT 6750 (P060027/S005) | MicroPort CRM USA, Inc. | 2009-02-03 |
| ZILVER VASCULAR STENT (P050017/S003) | Cook Ireland, Ltd. | 2009-02-03 |
| ZILVER VASCULAR STENT (P050017/S002) | Cook Ireland, Ltd. | 2009-02-03 |
| OVATIO VR 6250 & DR 6550 (P980049/S041) | MicroPort CRM USA, Inc. | 2009-02-03 |
| MEDTRONIC ATTAIN STARFIX (P060039/S002) | Medtronic, Inc. | 2009-02-02 |
| CARELINK PROGRAMMER (P890003/S146) | Medtronic, Inc. | 2009-01-30 |
| ZENITH TX2 TAA ENDOVASCULAR GRAFT (P070016/S003) | William Cook Europe Aps | 2009-01-27 |
| AMPLATZER DUCT OCCLUDER (P020024/S022) | ABBOTT MEDICAL | 2009-01-27 |
| WRENCH & REPLACEMENT SETSCREW ACCESSORY KIT & ACCESSORY KIT (P890003/S162) | Medtronic, Inc. | 2009-01-27 |
| AMPLATZER SEPTAL OCCLUDER (P000039/S028) | ABBOTT MEDICAL | 2009-01-27 |
| LEAD END CAP KIT/ LEAD ADAPTOR SLEEVE KIT/UPSIZING SLEEVE KIT (P900061/S082) | Medtronic Cardiac Rhythm Disease Management | 2009-01-27 |
| AMPLATZER MUSCULAR VSD OCCLUDER (P040040/S008) | ABBOTT MEDICAL | 2009-01-27 |
| ANGIOSCULPT PTCA SCORING BALLOON CATHETER (P050018/S005) | Spectranetics Corp. | 2009-01-27 |
| CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL BIOPROSTHESIS, MODEL 7000 AND 7000TFX (P860057/S051) | Edwards Lifesciences, LLC | 2009-01-27 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S012) | W. L. Gore & Associates, Inc. | 2009-01-26 |
| CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPROSTHESIS MODELS 6625LP AND 6625-ESR-LP (P870077/S026) | Edwards Lifesciences, LLC | 2009-01-23 |
| ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S023) | Medtronic, Inc. | 2009-01-23 |
| INSIGNIA AND CONTAK RENEWAL TR PULSE GENERATORS (P030005/S055) | Guidant Corp. | 2009-01-23 |
| TLC-II PORTABLE VAD DRIVER (P870072/S035) | Thoratec Laboratories Corp. | 2009-01-21 |
| ACCULINK/RX ACCULINK CAROTID STENT SYSTEMS (P040012/S029) | Abbott Vascular | 2009-01-21 |
| ST JUDE MEDICAL FRONTIER/FRONTIER II CRT-PS (P030035/S051) | ABBOTT MEDICAL | 2009-01-16 |
| ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P060033/S029) | Medtronic, Inc. | 2009-01-16 |
| ST JUDE MEDICAL AFFINITY/IDENTITY/VERITY/INTERGRITY/VICTORY/ZEPHYR PACEMAKERS (P880086/S172) | ABBOTT MEDICAL | 2009-01-16 |
| DRIVER & MICRO-DRIVER CORONARY STENT SYSTEMS (P030009/S032) | Medtronic, Ireland | 2009-01-16 |
| TALENT THORACIC STENT GRAFT SYSTEM (P070007/S005) | Medtronic Vascular | 2009-01-16 |
| MEDTRONIC ATTAIN STARFIX (P060039/S003) | Medtronic, Inc. | 2009-01-16 |
| ST JUDE MEDICAL AFFINITY/IDENTITY/VERITY/INTEGRITY/VICTORY/ZEPHYR PACEMAKERS (P880086/S171) | ABBOTT MEDICAL | 2009-01-16 |
| CYPHER SIROLIMUS-ELUTING CORONARY ON RAPTOR OVER-THE-WIRE DELIVERY SYSTEM /RAPTORAIL RAPID EXCHANGE DELIVERY SYSTEM (P020026/S060) | Cordis Corp. | 2009-01-16 |
| ST JUDE MEDICAL FRONTIER/FRONTIER II CRT-PS (P030035/S050) | ABBOTT MEDICAL | 2009-01-16 |
| TALENT ABDOMINAL STENT GRAFT SYSTEM (P070027/S005) | Medtronic Vascular | 2009-01-16 |
| CADENCE FAMILY OF ICDS (P910023/S198) | ABBOTT MEDICAL | 2009-01-15 |
| MICRONY FAMILY OF PACEMAKERS (P970013/S028) | ABBOTT MEDICAL | 2009-01-15 |
| FRONTIER/FRONTIER II FAMILY OF CRT-P (P030035/S046) | ABBOTT MEDICAL | 2009-01-15 |
| EPIC HF/ATLAS + HF FAMILY OF CRT-DS (P030054/S112) | ABBOTT MEDICAL | 2009-01-15 |
| SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS (P880006/S061) | St. Jude Medical, Inc. | 2009-01-15 |
| AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS (P880086/S173) | ABBOTT MEDICAL | 2009-01-15 |
| AFFINTY/IDENTITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS (P880086/S167) | ABBOTT MEDICAL | 2009-01-15 |
| FRONTIER/FRONTIER II FAMILY OF CRT-PS (P030035/S052) | ABBOTT MEDICAL | 2009-01-15 |
| INSYNC CRT-P (P010015/S060) | Medtronic, Inc. | 2009-01-14 |
| FLEXTOME CORONARY CUTTING BALLOON (P950020/S031) | Boston Scientific Corp | 2009-01-14 |
| ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM ROTALINK EXCHANGABLE CATHETER (P900056/S094) | Boston Scientific Corp | 2009-01-14 |
| PRODIGY IPG (P890003/S161) | Medtronic, Inc. | 2009-01-14 |
| KAPPA 400 DR/SR IPG (P970012/S050) | Medtronic, Inc. | 2009-01-14 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL & OVER-THE-WIRE) (P060008/S009) | Boston Scientific Corp | 2009-01-14 |
| TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (P960040/S186) | Boston Scientific | 2009-01-14 |
| GRUNTZIG DILACA CORONARY ARTERY BALLOON DILATATION CATHETERS (P790017/S099) | Medtronic, Ireland | 2009-01-14 |
| C/T SERIES/SELECTION/DIAMOND II/JADE II/RUBY II/TOPAZ II/VITA/VITA II/DEMA FAMILY OF IPG (P990001/S049) | Medtronic, Inc. | 2009-01-14 |
| COGNIS CARDIAC RESYNCHRONIZATION HE DEFIBRILLATOR (P010012/S199) | Boston Scientific Corp | 2009-01-14 |
| KAPPA 600/700/650/800/900/SIGMA/MEDTRONIC 350 IPG/ENPULSE/ADAPTA/VERSIA/SENSIA/RELIA FAMILIES OF IPG (P980035/S126) | Medtronic, Inc. | 2009-01-14 |
| PROMOTE CRT-D SYSTEM (P910023/S154) | ABBOTT MEDICAL | 2009-01-13 |
| RIATA ST OPTIM AND RIATA STS OPTIM (P950022/S042) | ABBOTT MEDICAL | 2009-01-13 |
| ATLAS II + HF CRT-D SYSTEM (P030054/S067) | ABBOTT MEDICAL | 2009-01-13 |
| DRIVER & MICRO-DRIVER CORONARY STENT SYSTEMS (P030009/S031) | Medtronic, Ireland | 2009-01-10 |
| GORE HELEX SEPTAL OCCLUDER (P050006/S009) | W. L. Gore & Associates, Inc. | 2009-01-10 |
| ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P060033/S028) | Medtronic, Inc. | 2009-01-10 |
| ENDEAVOR/ENDEAVOR SPRINT ZOTAROLIMU-ELUTING CORONARY STENT SYSTEM (P060033/S027) | Medtronic, Inc. | 2009-01-10 |
| KAPPA 400 DR/SR IPG (P970012/S049) | Medtronic, Inc. | 2009-01-09 |
| ATTAIN STARFIX LEAD (P060039/S005) | Medtronic, Inc. | 2009-01-09 |
| CAPSURE SP NOVUS/SP LEADS/CAPSURE SENSE LEADS (P830061/S044) | Medtronic Cardiac Rhythm Disease Management | 2009-01-09 |
| CS-SVC TRANSVENE LEAD (P980050/S039) | Medtronic, Inc. | 2009-01-09 |
| CAPSUREFIX NOVUS/SUREFIX/CAPSUREFIX LEADS (P930039/S029) | Medtronic, Inc. | 2009-01-09 |
| SELECTSECURE LEAD (P030036/S011) | Medtronic Cardiac Rhythm Disease Management | 2009-01-09 |
| INSYNC/INSYNC MARQUIS& MARQUIS II/III/INSYNC II/III PROTECT/INSYNC SENTRY/MAXIMO/MAXIMO II CRT-D/CONCERTO CRT-D/CONSULTA (P010031/S138) | Medtronic Cardiac Rhythm Disease Management | 2009-01-09 |
| WRENCH KIT/SERVICE KIT/CAPSURE VDD LEADS (P890003/S160) | Medtronic, Inc. | 2009-01-09 |
| PRODIGY IPG (P890003/S159) | Medtronic, Inc. | 2009-01-09 |
| INSYNC CARDIAC RESYNCHRONIZATION THERAPY PACING (CRT-P) & INSYNC III CRT-P (P010015/S058) | Medtronic, Inc. | 2009-01-09 |