| HANCOCK I LOW POROSITY & MODIFIED ORIFICE VALVED CONDUIT (P790007/S022) | Medtronic Heart Valves | 2009-07-27 |
| MOSAIC PORCINE BIOPROSTHESIS (P990064/S027) | Medtronic, Inc. | 2009-07-27 |
| HANCOCK II PORCINE BIOPROSTHESIS (P980043/S020) | Medtronic, Inc. | 2009-07-27 |
| ZENITH AAA ENDOVASCULAR GRAFT (P020018/S033) | Cook, Inc. | 2009-07-24 |
| 7F FISH-SP DEVICE (P050043/S002) | Morris Innovative Research, Inc. | 2009-07-24 |
| CARPENTIER-EDWARDS BIOPROSTHETIC VALVED CONDUIT (P870056/S034) | Edwards Lifesciences, LLC | 2009-07-23 |
| CADENCE FAMILY OF ICDS (P910023/S214) | ABBOTT MEDICAL | 2009-07-23 |
| XACT CAROTID STENT SYSTEM (P040038/S015) | Abbott Vascular, Inc. | 2009-07-23 |
| ZILVER VASCULAR STENT (P050017/S004) | Cook Ireland, Ltd. | 2009-07-23 |
| EPIC HF/ATLAS+ FAMILY OF CRT-DS (P030054/S129) | ABBOTT MEDICAL | 2009-07-23 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (P020026/S061) | Cordis Corp. | 2009-07-23 |
| ARTEGRAFT COLLAGEN VASCULAR GRAFT (N16837/S007) | LeMaitre Vascular, Inc. | 2009-07-21 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P860057/S058) | Edwards Lifesciences, LLC | 2009-07-21 |
| LATITUDE PATIENT MANAGEMENT SYSTEM (P910077/S094) | Boston Scientific | 2009-07-21 |
| MICRONY FAMILY OF PACEMAKERS (P970013/S030) | ABBOTT MEDICAL | 2009-07-17 |
| EPIC HF/ATLAS+HF FAMILY OF CRT-DS (P030054/S128) | ABBOTT MEDICAL | 2009-07-17 |
| CADENCE FAMILY OF ICDS (P910023/S213) | ABBOTT MEDICAL | 2009-07-17 |
| SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS (P880006/S063) | St. Jude Medical, Inc. | 2009-07-17 |
| BARD LIFESTENT VASCULAR STENT SYSTEMS (P070014/S002) | Bard Peripheral Vascular, Inc. | 2009-07-17 |
| XIENCE V AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (EECSS) (P070015/S021) | Abbott Vascular, Inc. | 2009-07-17 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S044) | W. L. Gore & Associates, Inc. | 2009-07-17 |
| AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS (P880086/S177) | ABBOTT MEDICAL | 2009-07-17 |
| FRONTIER/FRONTIER II FAMILY OF CRT-PS (P030035/S057) | ABBOTT MEDICAL | 2009-07-17 |
| AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS (P880086/S174) | ABBOTT MEDICAL | 2009-07-15 |
| VOYAGER NC CORONARY DILATATION CATHETER (P810046/S230) | Advanced Cardiovascular Systems, Inc. | 2009-07-15 |
| FRONTIER/FRONTIER II FAMILY OF CRT-PS (P030035/S053) | ABBOTT MEDICAL | 2009-07-15 |
| REPLY DR/SR (P950029/S046) | MicroPort CRM USA, Inc. | 2009-07-15 |
| ISOLINE 2CR PACINGS LEADS (P980049/S049) | MicroPort CRM USA, Inc. | 2009-07-15 |
| MYNX VASCULAR CLOSURE DEVICE (P040044/S015) | Cordis US Corporation | 2009-07-13 |
| ENDEAVOR & ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING STENT SYSTEM (P060033/S031) | Medtronic, Inc. | 2009-07-13 |
| TAXUS LIBERTE' PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S011) | Boston Scientific Corp | 2009-07-13 |
| REGENCY PACEMAKERS (P880006/S062) | St. Jude Medical, Inc. | 2009-07-10 |
| ADDVENT/AFFINITY/IDENTITY/VERITY/INTEGRITY/VICTORY/ZEPHYR PACEMAKERS (P880086/S176) | ABBOTT MEDICAL | 2009-07-10 |
| DURATA LEAD MODELS (P950022/S060) | ABBOTT MEDICAL | 2009-07-10 |
| MICRONY PACEMAKERS (P970013/S029) | ABBOTT MEDICAL | 2009-07-10 |
| RIATA/RIATA ST/DURATA LEADS (P950022/S062) | ABBOTT MEDICAL | 2009-07-10 |
| GORE VIABAHN TIPS ENDOPROSTHESIS (P040027/S015) | W. L. Gore & Associates, Inc. | 2009-07-10 |
| INSYNC CRT-P/INSYNC III CRT-P (P010015/S069) | Medtronic, Inc. | 2009-07-10 |
| INSYNC FAMILY OF ICDS/CONCERTO/MAXIMO II CRT-D/CONSULTA CRT-D (P010031/S157) | Medtronic Cardiac Rhythm Disease Management | 2009-07-10 |
| TENDRIL/TENDRIL ST/OPTISENSE LEADS (P960013/S047) | ABBOTT MEDICAL | 2009-07-10 |
| KAPPA 600/700/650/800/900/RELIA/SIGMA/MEDTRONIC 350/ENPULSE/ENRHYTHM/AT500/ADAPTA/VERSA/SENSIA IPGS (P980035/S137) | Medtronic, Inc. | 2009-07-10 |
| DEMA IPG/DDDR/CLARITY SSIR/DIAMOND III/RUBY III/TOPAZ III/JADE III/VITA 2 DDDR (P990001/S054) | Medtronic, Inc. | 2009-07-10 |
| EPIC HF/EPIC+ HF/EPIC II HF/EPIC II+HF/ATLAS HF/ATLAS+HF/ATLAS II HF/ATLAS II+HF CRT-DS/QUICKSITE/QUICKFLEX LEADS (P030054/S127) | ABBOTT MEDICAL | 2009-07-10 |
| COGNIS FAMILIES (P010012/S216) | Boston Scientific Corp | 2009-07-10 |
| TELIGEN FAMILIES (P960040/S201) | Boston Scientific | 2009-07-10 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S021) | W. L. Gore & Associates, Inc. | 2009-07-10 |
| PASSIVE PLUS/ISOFLEX S/ISOFLEX P/ISOFLEX OPTIM LEADS (P960030/S026) | ABBOTT MEDICAL | 2009-07-10 |
| KAPPA 400 DR IPG/KAPPA 400 SR IPG (P970012/S055) | Medtronic, Inc. | 2009-07-10 |
| GEM II/MARQUIS/MAXIMO/INTRINSIC/ENTRUST/VIRTUOSO ICDS/MAXIMO II CRT-D/SECURA FAMILY ICD (P980016/S196) | Medtronic Cardiac Rhythm Disease Management | 2009-07-10 |
| CADENCE ICDS (P910023/S212) | ABBOTT MEDICAL | 2009-07-10 |
| FRONTIER/FRONTIER II PACEMAKERS/AESCULA LEADS (P030035/S056) | ABBOTT MEDICAL | 2009-07-10 |
| XIENCE V AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (EECSS) (P070015/S017) | Abbott Vascular, Inc. | 2009-07-09 |
| CARPENTIER-EDWARDS BIOPROSTHETIC PULMONIC VALVED CONDUIT (P870056/S033) | Edwards Lifesciences, LLC | 2009-07-09 |
| SUTURE MEDIATED CLOSURE SYSTEMS & ASSOCIATED ACCESSORIES (P960043/S065) | Abbott Vascular, Inc. | 2009-07-09 |
| CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS (P860057/S056) | Edwards Lifesciences, LLC | 2009-07-09 |
| MEDTRONIC HALL ROTATABLE AORTIC VALVE COLLAGEN IMPREGNATED CONDUIT (P790018/S052) | Medtronic Cardiac Surgery | 2009-07-09 |
| VASCULAR CLOSURE SYSTEMS (P050007/S014) | Abbott Vascular Devices | 2009-07-09 |
| ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM (P980037/S031) | Boston Scientific Corp | 2009-07-09 |
| EP TECH CARDIAC ABLATION SYSTEM (P920047/S031) | Boston Scientific Corp | 2009-07-08 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S020) | W. L. Gore & Associates, Inc. | 2009-07-08 |
| EP TECH EPT-1000XP RF ABLATION SYSTEM (P020025/S015) | Boston Scientific | 2009-07-08 |
| TELIGEN PULSE GENERATORS (P960040/S197) | Boston Scientific | 2009-07-07 |
| FREEZOR CARDIAC/FREEZOR XTRA/FREEZOR MAX SURGICAL CARDIAC CRYOABLATION CATHETER/CCT.2 CRYOCONSOLE SYSTEM (P020045/S026) | Medtronic Cryocath, LP | 2009-07-07 |
| COGNIS PULSE GENERATORS (P010012/S211) | Boston Scientific Corp | 2009-07-07 |
| MODEL 3120 ZOOM LATITUDE PROGRAMMING SYSTEM (P910077/S095) | Boston Scientific | 2009-07-06 |
| XIENCE V AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (EECSS) (P070015/S019) | Abbott Vascular, Inc. | 2009-07-02 |
| DURATA/RIATA ST OPTIM/RIATA ST FAMILY OF LEADS (P950022/S061) | ABBOTT MEDICAL | 2009-07-02 |
| DURA STAR RX PTCA BALLOON DILATATION CATHETER (P880003/S096) | Cordis Corp. | 2009-07-02 |
| CONTAK RENEWAL (P010012/S215) | Boston Scientific Corp | 2009-06-30 |
| 1888 TENDRIL LEADS (P960013/S043) | ABBOTT MEDICAL | 2009-06-29 |
| COGNIS FAMILY (P010012/S214) | Boston Scientific Corp | 2009-06-26 |
| ACUITY STEERABLE LEAD (P050046/S004) | Guidant Corp. | 2009-06-26 |
| BIOGLUE SURGICAL ADHESIVE (P010003/S014) | Cryolife, Inc. | 2009-06-26 |
| TELIGEN FAMILY (P960040/S200) | Boston Scientific | 2009-06-26 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S013) | W. L. Gore & Associates, Inc. | 2009-06-25 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S018) | Boston Scientific Corp | 2009-06-25 |
| ACUITY SPIRAL LEAD (P010012/S182) | Boston Scientific Corp | 2009-06-25 |
| C & T SERIES IPG & DEMA FAMILIES (P990001/S050) | Medtronic, Inc. | 2009-06-24 |
| INSYNC & INSYNC II CRT-P (P010015/S062) | Medtronic, Inc. | 2009-06-24 |
| MARQUIS/MAXIMO/INTRINSIC/ENTRUST/VIRTUOSO/MAXIMO II/SECURA/VIRTUOSO II FAMILIES OF ICDS (P980016/S179) | Medtronic Cardiac Rhythm Disease Management | 2009-06-24 |
| ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM (P980037/S030) | Boston Scientific Corp | 2009-06-24 |
| KAPPA 400 DR/SR IPG (P970012/S051) | Medtronic, Inc. | 2009-06-24 |
| ST JUDE MEDICAL BIOCOR/BIOCOR SUPRA/EPIC/EPIC SUPRA HEART VALVES (P040021/S009) | ABBOTT MEDICAL | 2009-06-24 |
| KAPPA IPGS, SIGMA IPGS, ENPULSE IPGS, ENRHYTHM IPGS, AT500 PACING SYSTEM, ADAPTA/SENSIA/VERSA IPGS AND RELIA IPG (P980035/S128) | Medtronic, Inc. | 2009-06-24 |
| ENRHYTHM IPG FAMILY (P980035/S136) | Medtronic, Inc. | 2009-06-24 |
| PRODIGY IPG (P890003/S164) | Medtronic, Inc. | 2009-06-24 |
| ENTRUST ICD (P980016/S191) | Medtronic Cardiac Rhythm Disease Management | 2009-06-24 |
| INSYNC/CONCERTO/MAXIMO/CONSULTA FAMILIES OF ICDS & CRT-DS (P010031/S143) | Medtronic Cardiac Rhythm Disease Management | 2009-06-24 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P070015/S020) | Abbott Vascular, Inc. | 2009-06-23 |
| ANGIOSCULPT PTCA SCORING BALLOON CATHETER (P050018/S007) | Spectranetics Corp. | 2009-06-19 |
| CADENCE FAMILY OF ICDS (P910023/S211) | ABBOTT MEDICAL | 2009-06-18 |
| SMART CONTROL NITINOL STENT SYSTEM (P020036/S015) | Cordis US Corporation | 2009-06-18 |
| CORDIS PRECISE/PRECISE RX/PRECISE PRO RX NITINOL STENT SYSTEMS (P030047/S018) | Cordis US Corporation | 2009-06-18 |
| EPIC HF/ATLAS+HF FAMILY OF CRT-DS (P030054/S126) | ABBOTT MEDICAL | 2009-06-18 |
| SJM DURATA, RIATA ST OPTIM & RIATA ST FAMILIES OF DEFIBRILLATION LEADS (P950022/S055) | ABBOTT MEDICAL | 2009-06-18 |
| THERAPY DUAL 8/THERAPY & SAFIRE TX ABLATION CATHETERS (P040042/S013) | Irvine Biomedical,Inc.(Ibi) | 2009-06-17 |
| THERAPY CARDIAC ABLATION CATHETERS (P040014/S008) | Irvine Biomedical, Inc. | 2009-06-17 |
| INSYNC II/III MARQUIS/INSYNC II/III PROTECT/INSYNC SENTRY/INSYNC MAXIMO ICDS/CONCERTO/MAXIMO II/CONSULTA/CONCERTO II CRT (P010031/S155) | Medtronic Cardiac Rhythm Disease Management | 2009-06-17 |
| MARQUIS/MAXIMO/INTRINSIC/ENTRUST/VIRTUOSO/VIRTUOSO II/MAXIMO II/SECURA FAMILIES OF ICDS (P980016/S194) | Medtronic Cardiac Rhythm Disease Management | 2009-06-17 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (EECSS) (P070015/S018) | Abbott Vascular, Inc. | 2009-06-16 |