| CONCERTO/INSYNC SENTRY/INSYNC MAXIMO (P010031/S104) | Medtronic Cardiac Rhythm Disease Management | 2008-08-28 |
| POWERLINK SYSTEM (P040002/S020) | Endologix, LLC | 2008-08-27 |
| STARCLOSE AND STARCLOSE SE VASCULAR CLOSURE SYSTEMS (P050007/S009) | Abbott Vascular Devices | 2008-08-25 |
| INSYNC SENTRY FAMILY/INSYNC II/III MARQUIS/INSYNC II/III PROTECT/INSYNC MAXIMO FAMILY/CONCERTO (P010031/S112) | Medtronic Cardiac Rhythm Disease Management | 2008-08-22 |
| MAXIMO/MAXIMO II DR/VR/MARQUIS/INTRINSIC/ENTRUST/VIRTUOSO (P980016/S143) | Medtronic Cardiac Rhythm Disease Management | 2008-08-22 |
| ENRHYTHM (P980035/S105) | Medtronic, Inc. | 2008-08-22 |
| VOYAGER NC CORONARY DILATATION CATHETER (P810046/S226) | Advanced Cardiovascular Systems, Inc. | 2008-08-21 |
| CONTAK RENEWAL & LIVIAN FAMILY OF CRT-DS (P010012/S187) | Boston Scientific Corp | 2008-08-21 |
| VITALITY HE & CONFIENT ICDS (P960040/S173) | Boston Scientific | 2008-08-21 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S023) | W. L. Gore & Associates, Inc. | 2008-08-20 |
| CYPHER SIROLIMUS-ELUTING CORONARY SYSTEM (P020026/S055) | Cordis Corp. | 2008-08-20 |
| EPIC HF CRT-D SYSTEM (P030054/S100) | ABBOTT MEDICAL | 2008-08-19 |
| CADENCE ICD SYSTEM (P910023/S185) | ABBOTT MEDICAL | 2008-08-19 |
| VIRTUOSO (P980016/S121) | Medtronic Cardiac Rhythm Disease Management | 2008-08-18 |
| CONCERTO (P010031/S091) | Medtronic Cardiac Rhythm Disease Management | 2008-08-18 |
| SECURA DR/VR & MAXIMO II DR/VR (P980016/S142) | Medtronic Cardiac Rhythm Disease Management | 2008-08-15 |
| CONSULTA CRT-D & MAXIMO II CRT-D (P010031/S111) | Medtronic Cardiac Rhythm Disease Management | 2008-08-15 |
| TELIGEN HE (P960040/S172) | Boston Scientific | 2008-08-14 |
| C-SERIES & T-SERIES (P990001/S038) | Medtronic, Inc. | 2008-08-14 |
| CORDIS PRECISE RX NITINOL STENT SYSTEM & PRECISE PRO RX NITINOL STENT SYSTEM (P030047/S014) | Cordis US Corporation | 2008-08-14 |
| CONCERTO (P010031/S110) | Medtronic Cardiac Rhythm Disease Management | 2008-08-14 |
| VIRTUOSO (P980016/S141) | Medtronic Cardiac Rhythm Disease Management | 2008-08-14 |
| ENRHYTHM (P980035/S104) | Medtronic, Inc. | 2008-08-14 |
| COGNIS HE (P010012/S186) | Boston Scientific Corp | 2008-08-14 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S007) | W. L. Gore & Associates, Inc. | 2008-08-14 |
| CARDIOWEST TEMPORARY TOTAL ARTIFICAL HEART (TAH-T) SYSTEM (P030011/S003) | Syncardia Systems, LLC | 2008-08-11 |
| SPRINT QUATTRO LEAD (P920015/S047) | Medtronic, Inc. | 2008-08-08 |
| ATTAIN STARFIX LEAD (P060039/S001) | Medtronic, Inc. | 2008-08-08 |
| ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S012) | Medtronic, Inc. | 2008-08-08 |
| FREESTYLE AORTIC ROOT BIOPROSTHESIS (P970031/S023) | Medtronic, Inc. | 2008-08-07 |
| S.M.A.R.T CONTROL NITINOL STENT SYSTEM (P020036/S010) | Cordis US Corporation | 2008-08-07 |
| MOSAIC PORCINE BIOPROSTHESIS (P990064/S025) | Medtronic, Inc. | 2008-08-07 |
| VASCULAR SOLUTIONS DUETT SEALING DEVICE (P990037/S026) | Vascular Solutions, Inc. | 2008-08-07 |
| INSYNC III CRT-P (P010015/S039) | Medtronic, Inc. | 2008-08-04 |
| ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM (P980037/S026) | Boston Scientific Corp | 2008-08-04 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM & RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (P020026/S053) | Cordis Corp. | 2008-08-04 |
| ENRHYTHM IPG (P980035/S088) | Medtronic, Inc. | 2008-08-04 |
| SECURA DR/VR & MAXIMO II DR/VR (P980016/S139) | Medtronic Cardiac Rhythm Disease Management | 2008-08-01 |
| EXPRESS/EXPRESS2 CORONARY STENT SYSTEM (P020009/S045) | Boston Scientific Scimed, Inc. | 2008-08-01 |
| LIBERTE CORONARY STENT SYSTEM (P040016/S032) | Boston Scientific Scimed, Inc. | 2008-08-01 |
| CONSULTA CRT-D & MAXIMO II CRT-D (P010031/S108) | Medtronic Cardiac Rhythm Disease Management | 2008-08-01 |
| TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S057) | Boston Scientific Corp | 2008-08-01 |
| SJM LEADS (P960030/S021) | ABBOTT MEDICAL | 2008-07-31 |
| QUICKSITE AND QUICKFLEX FAMILY OF LEADS (P030054/S079) | ABBOTT MEDICAL | 2008-07-31 |
| RIATA FAMILY OF HIGH VOLTAGE LEADS (P950022/S051) | ABBOTT MEDICAL | 2008-07-31 |
| SJM PACEMAKERS (P030035/S039) | ABBOTT MEDICAL | 2008-07-31 |
| EPIC HF/ATLAS+ HF FAMILY OF CRT-DS (P030054/S097) | ABBOTT MEDICAL | 2008-07-31 |
| SJM PACEMAKERS (P880086/S160) | ABBOTT MEDICAL | 2008-07-31 |
| TENDRIL FAMILY F LOW VOLTAGE LEADS (P960013/S037) | ABBOTT MEDICAL | 2008-07-31 |
| VIRTUOSO/SECURA DR/VR/MAXIMO II DR/VR ICD (P980016/S134) | Medtronic Cardiac Rhythm Disease Management | 2008-07-25 |
| TELIGEN FAMILY (P960040/S171) | Boston Scientific | 2008-07-25 |
| REPLY PACEMAKERS (P950029/S032) | MicroPort CRM USA, Inc. | 2008-07-25 |
| COGNIS FAMILY (P010012/S185) | Boston Scientific Corp | 2008-07-25 |
| CONCERTO CRT-D/CONSULTA CRT-D/MAXIMO II CRT-D (P010031/S103) | Medtronic Cardiac Rhythm Disease Management | 2008-07-25 |
| MITROFLOW AORTIC PERICARDIAL HEART VALVE (P060038/S001) | Corcym Canada Corp | 2008-07-25 |
| TELIGEN ICD PULSE GENERATORS (P960040/S170) | Boston Scientific | 2008-07-23 |
| COGNIS CRT-D PULSE GENERATORS (P010012/S184) | Boston Scientific Corp | 2008-07-23 |
| SYMPHONY DR/SR & ELA RHAPSODY +DR/DR/SR (P950029/S037) | MicroPort CRM USA, Inc. | 2008-07-23 |
| OVATIO VR & DR (P980049/S038) | MicroPort CRM USA, Inc. | 2008-07-23 |
| OVATIO CRT (P060027/S003) | MicroPort CRM USA, Inc. | 2008-07-23 |
| STARCLOSE & STARCLOSE SE VASCULAR CLOSURE SYSTEMS (P050007/S010) | Abbott Vascular Devices | 2008-07-23 |
| MYNX VASCULAR CLOSURE DEVICE (P040044/S008) | Cordis US Corporation | 2008-07-22 |
| CONTAK RENEWAL TR (P030005/S053) | Guidant Corp. | 2008-07-18 |
| CONTAK RENEWAL/VITALITY (P010012/S181) | Boston Scientific Corp | 2008-07-18 |
| VIGOR DR/SR & DISCOVER/MERIDIAN, PDP (P940031/S064) | Boston Scientific | 2008-07-18 |
| INSYNC III (P010015/S045) | Medtronic, Inc. | 2008-07-18 |
| PRIZM/VITALITY (P960040/S169) | Boston Scientific | 2008-07-18 |
| MEDTRONIC ADAPTA, VERSA AND SENSIA IMPLANTABLE PULSE GENERATORS (IPG) PRODUCT FAMILY (P980035/S101) | Medtronic, Inc. | 2008-07-18 |
| KAPPA 400 DR/SR (P970012/S035) | Medtronic, Inc. | 2008-07-18 |
| CONCERTO (P010031/S099) | Medtronic Cardiac Rhythm Disease Management | 2008-07-18 |
| KAPPA/ENPULSE II/ADAPTA/VERSA/SENIA (P980035/S100) | Medtronic, Inc. | 2008-07-18 |
| VENTAK MINI & CONTAK RENEWAL 3 (P910077/S089) | Boston Scientific | 2008-07-18 |
| VIRTUOSO DR/VR (P980016/S130) | Medtronic Cardiac Rhythm Disease Management | 2008-07-18 |
| EPICARDIAL TRANSVENE LEAD AND RELATED ACCESSORIES (P900061/S076) | Medtronic Cardiac Rhythm Disease Management | 2008-07-17 |
| CADENCE FAMILY OF ICDS (P910023/S182) | ABBOTT MEDICAL | 2008-07-17 |
| LEADS SERVICE KIT & LEADS WRENCH KIT (P890003/S142) | Medtronic, Inc. | 2008-07-17 |
| CAPSURE EPI UNIPOLAR & BIPOLAR LEAD (P950024/S011) | Medtronic, Inc. | 2008-07-17 |
| LEAD ASSEMBLY (P030036/S007) | Medtronic Cardiac Rhythm Disease Management | 2008-07-17 |
| EPIC HF/ATLAS + HF FAMILY OF CRT-DS (P030054/S096) | ABBOTT MEDICAL | 2008-07-17 |
| LEAD ASSEMBLY (P010015/S044) | Medtronic, Inc. | 2008-07-17 |
| SVC/CS TRANSVENE LEAD (P980050/S034) | Medtronic, Inc. | 2008-07-17 |
| VARIOUS FAMILY OF LEADS (P920015/S046) | Medtronic, Inc. | 2008-07-17 |
| ST JUDE MECHANICAL HEART VALVE (P810002/S066) | ABBOTT MEDICAL | 2008-07-16 |
| HANCOCK II BIOPROSTHESIS (P980043/S017) | Medtronic, Inc. | 2008-07-15 |
| AMPLATZER MUSCULAR VSD OCCLUDER (P040040/S005) | ABBOTT MEDICAL | 2008-07-15 |
| AMPLATZER DUCT OCCLUDER (P020024/S020) | ABBOTT MEDICAL | 2008-07-15 |
| AMPLATZER SEPTAL OCCLUDER & MULTI-FENESTRATED SEPTAL OCCLUDER CRIBRIFORM (P000039/S026) | ABBOTT MEDICAL | 2008-07-15 |
| MEDTRONIC VASCULAR TALENT ABDOMINAL STENT GRAFT SYSTEM (P070027/S001) | Medtronic Vascular | 2008-07-15 |
| MOSAIC PORCINE BIOPROSTHESIS (P990064/S024) | Medtronic, Inc. | 2008-07-15 |
| MEDTRONIC CONSULTA & MAXIMO ICDS (P010031/S096) | Medtronic Cardiac Rhythm Disease Management | 2008-07-11 |
| VARIOUS MODELS OF PHILOS/PHILOS, AXIOS, PROTOS PULSE GENERATOR (P950037/S057) | Biotronik, Inc. | 2008-07-11 |
| MEDTRONIC SECURA & MAXIMO II ICDS (P980016/S127) | Medtronic Cardiac Rhythm Disease Management | 2008-07-11 |
| SECURA DR/VR & MAXIMO II DR/VR (P980016/S137) | Medtronic Cardiac Rhythm Disease Management | 2008-07-11 |
| CONSULTA CRT-D & MAXIMO II CRT-D (P010031/S106) | Medtronic Cardiac Rhythm Disease Management | 2008-07-11 |
| 2490C CARELINK MONITOR (P890003/S140) | Medtronic, Inc. | 2008-07-10 |
| VIRTUOSO (P980016/S136) | Medtronic Cardiac Rhythm Disease Management | 2008-07-10 |
| CARPENTIER-SUPRAANNULAR (S.A.V.) BIOPROSTHESIS (P010041/S016) | Edwards Lifesciences, LLC | 2008-07-10 |
| EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS (P000007/S017) | Edwards Lifesciences, LLC | 2008-07-10 |
| CARPENTIER-EDWARDS PERIMOUNT PERCARDIAL BIOPROSTHESIS (P860057/S048) | Edwards Lifesciences, LLC | 2008-07-10 |
| CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPROSTHESIS (P870077/S028) | Edwards Lifesciences, LLC | 2008-07-10 |