| FRONTIER/FRONTIER II FAMILY OF CRT-PS (P030035/S048) | ABBOTT MEDICAL | 2008-11-13 |
| ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S016) | Medtronic, Inc. | 2008-11-13 |
| CONCERTO CRT-D (P010031/S129) | Medtronic Cardiac Rhythm Disease Management | 2008-11-13 |
| ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P060033/S019) | Medtronic, Inc. | 2008-11-13 |
| ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S015) | Medtronic, Inc. | 2008-11-13 |
| AFFINITY/IDENTITY/INTEGRITY/VICTORY/ZEPHYR FAMILY OF PACEMAKERS (P880086/S169) | ABBOTT MEDICAL | 2008-11-13 |
| XACT CAROTID STENT SYSTEM (P040038/S013) | Abbott Vascular, Inc. | 2008-11-10 |
| RELIANCE FAMILY ACTIVE FIXATION TACHY LEADS (P910073/S075) | Boston Scientific | 2008-11-07 |
| MAXIMO DR/VR, MARQUIS DR/VR, INTRINSIC ICDS (P980016/S161) | Medtronic Cardiac Rhythm Disease Management | 2008-11-07 |
| APEX MONORAIL AND OVER-THE-WIRE PTCA DILATATION CATHETERS (P860019/S208) | Scimed Life Systems, Inc. | 2008-11-07 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S024) | W. L. Gore & Associates, Inc. | 2008-11-07 |
| NAVISTAR RMT DIAGNOSTIC/ABLATION STEERABLE TIP CATHETER (P990025/S016) | Biosense Webster, Inc. | 2008-11-07 |
| NAVISTAR RMT CATHETER FAMILY (P030031/S012) | Biosense Webster, Inc. | 2008-11-07 |
| NAVISTAR RMT DS DIAGNOSTIC/ABLATION STEERABLE TIP CATHETER (P010068/S013) | Biosense Webster, Inc. | 2008-11-07 |
| NAVISTAR RMT THERMOCOOL DIAGNOSTIC/ABLATION STEERABLE TIP CATHETER (P040036/S009) | Biosense Webster, Inc. | 2008-11-07 |
| PHILOS II FAMILY OF PULSE GENERATORS (P950037/S065) | Biotronik, Inc. | 2008-11-06 |
| OVATIO VR & DR ICDS (P980049/S036) | MicroPort CRM USA, Inc. | 2008-11-06 |
| COROX OTW (-S) BP LEFT VENTRICULAR LEADS (P070008/S005) | Biotronik, Inc. | 2008-11-06 |
| INSYNC FAMILIES OF ICD & CONCERTO ICD (P010031/S128) | Medtronic Cardiac Rhythm Disease Management | 2008-11-05 |
| ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S086) | Boston Scientific Corp | 2008-11-05 |
| MAXIMO/MARQUIS/INTRINSIC 30/INTRINSIC/ENTRUST (P980016/S160) | Medtronic Cardiac Rhythm Disease Management | 2008-11-05 |
| TALENT ABDOMINAL STENT GRAFT SYSTEM (P070027/S002) | Medtronic Vascular | 2008-11-05 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S035) | W. L. Gore & Associates, Inc. | 2008-11-05 |
| ADAPTA/SENSIA/ VERSA FAMILY OF IMPLANTABLE PULSE GENERATORS (IPGS) (P980035/S095) | Medtronic, Inc. | 2008-11-05 |
| ST JUDE MEDICAL MECHANICAL HEART VALVE (P810002/S065) | ABBOTT MEDICAL | 2008-11-05 |
| LUMOS ICDS/XELOS DR-T ICD/LEXOS ICDS (P000009/S026) | Biotronik, Inc. | 2008-11-04 |
| DRIVER & MICRO-DRIVER CORONARY STENT SYSTEM (P030009/S025) | Medtronic, Ireland | 2008-11-04 |
| KRONOS LV-T CRT-D (P050023/S011) | Biotronik, Inc. | 2008-11-04 |
| ENDOLOGIX, INC. POWERLINK SYSTEM (P040002/S019) | Endologix, LLC | 2008-11-04 |
| ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P060033/S010) | Medtronic, Inc. | 2008-11-04 |
| EXPRESS MR & OTW CORONARY STENT SYSTEM (P020009/S047) | Boston Scientific Scimed, Inc. | 2008-11-04 |
| ACTROS, AXIOS, BA03, CYLOS, DROMOS, KAIROS, PHILOS, PHILOS II, AND PROTOS FAMILIES OF PULSE GENERATORS (P950037/S059) | Biotronik, Inc. | 2008-11-04 |
| CARDIAC AIRBAG AND BELOS FAMILIES OF ICDS (P980023/S031) | Biotronik, Inc. | 2008-11-04 |
| PTCA CATHETERS (P860019/S229) | Scimed Life Systems, Inc. | 2008-11-04 |
| STRATOS LV/LV-T (P070008/S001) | Biotronik, Inc. | 2008-11-04 |
| OVATIO CRT-D SYSTEM (P060027/S002) | MicroPort CRM USA, Inc. | 2008-10-31 |
| OVATIO VR 6250 AND OVATIO DR 6550 (P980049/S040) | MicroPort CRM USA, Inc. | 2008-10-31 |
| THORATEC IMPLANTABLE VENTRICULAR ASSIST DEVICE (P870072/S040) | Thoratec Laboratories Corp. | 2008-10-31 |
| OVATIO CRT 6750 (P060027/S004) | MicroPort CRM USA, Inc. | 2008-10-31 |
| RELIANCE FAMILY OF LEADS (P910073/S073) | Boston Scientific | 2008-10-31 |
| SPRINTER LEGEND RX BALLOON DILATATION CATHETER (P790017/S096) | Medtronic, Ireland | 2008-10-31 |
| PRECISE NITINOL STENT SYSTEM (P030047/S015) | Cordis US Corporation | 2008-10-30 |
| SMART NITINOL STENT SYSTEM & SMART CONTROL NITINOL STENT SYSTEM (P020036/S011) | Cordis US Corporation | 2008-10-30 |
| ATS 3F AORTIC BIOPROSTHESIS (P060025) | Medtronic, Inc. | 2008-10-30 |
| CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS (P870077/S029) | Edwards Lifesciences, LLC | 2008-10-29 |
| CARPENTIER-EDWARDS SUPRAANNULAR (S.A.V.) BIOPROSTHESIS (P010041/S017) | Edwards Lifesciences, LLC | 2008-10-29 |
| ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S089) | Boston Scientific Corp | 2008-10-29 |
| CARPENTIER-EDWARDS VALVED CONDUIT BIOPROSTHESIS (P870056/S030) | Edwards Lifesciences, LLC | 2008-10-29 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P860057/S050) | Edwards Lifesciences, LLC | 2008-10-29 |
| EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS (P000007/S018) | Edwards Lifesciences, LLC | 2008-10-29 |
| FLAIR ENDOVASCULAR STENT GRAFT WITH OPTIMIZED DELIVERY SYSTEM (P060002/S002) | Bard Peripheral Vascular | 2008-10-28 |
| EASYTRAK 3 (P910073/S074) | Boston Scientific | 2008-10-24 |
| MARQUIS DR/VR 7274/7230 ICD (P980016/S150) | Medtronic Cardiac Rhythm Disease Management | 2008-10-24 |
| VIRTUOSO II ICD DR/VR (P980016/S157) | Medtronic Cardiac Rhythm Disease Management | 2008-10-23 |
| CONCENTRO II CRT-D (P010031/S125) | Medtronic Cardiac Rhythm Disease Management | 2008-10-23 |
| CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS (P050019) | Boston Scientific Corp | 2008-10-23 |
| MICRO-DRIVER RAPID EXCHANGE (RX) CORONARY STENT SYSTEM (P030009/S020) | Medtronic, Ireland | 2008-10-22 |
| VIRTUOSO II ICD DR/VR MODELS (P980016/S158) | Medtronic Cardiac Rhythm Disease Management | 2008-10-21 |
| CONCERTO II CRT-D MODELS C154DWK, C164AWK (P010031/S126) | Medtronic Cardiac Rhythm Disease Management | 2008-10-21 |
| SELECTSECURE 3830 (P030036/S003) | Medtronic Cardiac Rhythm Disease Management | 2008-10-21 |
| CARELINK MONITOR MODEL 2490C, MODEL 2491 DDMA AND CARDIOSIGHT READER MODEL 2020A (P890003/S150) | Medtronic, Inc. | 2008-10-21 |
| INSYNC & INSYNC III (P010015/S053) | Medtronic, Inc. | 2008-10-17 |
| VARIOUS FAMILIES OF PACEMAKERS (P980035/S116) | Medtronic, Inc. | 2008-10-17 |
| CLARITY, DIAMOND 3, JADE 3, RUBY 3, TOPAZ 3, VITA 2 DDR, C-SERIES, AND T-SERIES (P990001/S045) | Medtronic, Inc. | 2008-10-17 |
| SECURA ICD (P980016/S156) | Medtronic Cardiac Rhythm Disease Management | 2008-10-17 |
| STELID II, STELIX, AND STLIX II STEROID-ELUTING PACING LEADS (P020030/S004) | MicroPort CRM USA, Inc. | 2008-10-17 |
| VARIOUS FAMILIES OF CRT-ICDS (P010031/S122) | Medtronic Cardiac Rhythm Disease Management | 2008-10-17 |
| MEDTRONIC MODEL 5388 & 5348 EXTERNAL PULSE GENERATOR (P820003/S085) | Medtronic Cardiac Rhythm Disease Management | 2008-10-17 |
| CONCERTO/CONSULTA/MAXIMO II (P010031/S123) | Medtronic Cardiac Rhythm Disease Management | 2008-10-17 |
| VARIOUS FAMILIES OF ICDS (P980016/S154) | Medtronic Cardiac Rhythm Disease Management | 2008-10-17 |
| ENRHYTHM IPG& ADAPTA/VERSA/SENSIA FAMILY (P980035/S117) | Medtronic, Inc. | 2008-10-17 |
| ENDOTAK RELIANCE (P910073/S076) | Boston Scientific | 2008-10-17 |
| OVATIO VR/DR (P980049/S042) | MicroPort CRM USA, Inc. | 2008-10-17 |
| CONSULTA CRT-D & MAXIMO II CRT-D (P010031/S124) | Medtronic Cardiac Rhythm Disease Management | 2008-10-17 |
| ENTRUST/VIRTUOSO/SECURA DR/VR/MAXIMO II DR/VR FAMILIES OF ICDS (P980016/S155) | Medtronic Cardiac Rhythm Disease Management | 2008-10-17 |
| OVATIO CRT (P060027/S006) | MicroPort CRM USA, Inc. | 2008-10-17 |
| KAPPA 400 DR/SR (P970012/S044) | Medtronic, Inc. | 2008-10-17 |
| SYMPHONY SR/DR & RHAPSODY SR/DR (P950029/S038) | MicroPort CRM USA, Inc. | 2008-10-17 |
| ANEURX STENT GRAFT SYSTEM (P990020/S033) | Medtronic Vascular | 2008-10-16 |
| ENDOLOGIX POWERLINK SYSTEM, VISIFLEX IS DELIVERY SYSTEM (P040002/S021) | Endologix, LLC | 2008-10-14 |
| CARELINK MONITOR MODEL 2490C, MODEL 2491 DDMA AND CARDIOSIGHT READER MODEL 2020A (P890003/S148) | Medtronic, Inc. | 2008-10-14 |
| HELIOS II ABLATION CATHETER (P050029) | Stereotaxis, Inc. | 2008-10-10 |
| ENRHYTHM IPG (P980035/S115) | Medtronic, Inc. | 2008-10-10 |
| STEEROCATH T CARDIAC ABLATION CATHETER (P920047/S038) | Boston Scientific Corp | 2008-10-10 |
| NC SPRINTER RX BALLOON DILATATION CATHETER (P790017/S095) | Medtronic, Ireland | 2008-10-10 |
| VARIOUS FAMILIES OF ICDS (P980016/S153) | Medtronic Cardiac Rhythm Disease Management | 2008-10-10 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE) (P060008) | Boston Scientific Corp | 2008-10-10 |
| C-SERIES AND T-SERIES DEVICES (P990001/S044) | Medtronic, Inc. | 2008-10-10 |
| QUICKFLEX FAMILY OF LEADS (P030054/S105) | ABBOTT MEDICAL | 2008-10-10 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P070015/S006) | Abbott Vascular, Inc. | 2008-10-10 |
| INSYNCII/ III PROTECT/INSYNC II/III MARQUIS/INSYNC SENTRY/MAXIMO/CONCERTO/MAXIMO II (P010031/S121) | Medtronic Cardiac Rhythm Disease Management | 2008-10-10 |
| SJM ISOFLEX OPTIM LEADS (P960030/S023) | ABBOTT MEDICAL | 2008-10-09 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT SYSTEM ON THE RAPTOR OTW DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVERY S (P020026/S048) | Cordis Corp. | 2008-10-09 |
| FINELINE II STEROX EZ LEADS (P960004/S041) | Boston Scientific | 2008-10-09 |
| ISOLINE 2CR (P980049/S039) | MicroPort CRM USA, Inc. | 2008-10-09 |
| ON-X PROSTHETIC HEART VALVE (P000037/S014) | On-X Life Technologies, Inc. | 2008-10-09 |
| QUANTUM MAVERICK MONORAIL & OTW PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETERS (P860019/S227) | Scimed Life Systems, Inc. | 2008-10-08 |
| PROTEGE GPS & PROTEGE RX CAROTID STENT SYSTEMS (P060001/S006) | Medtronic Vascular, Inc. | 2008-10-08 |
| POWERLINK SYSTEM, 25MM, 28MM, AND 34MM SUPRARENAL BIFURCATED STENT GRAFTS AND ACCESSORIES (P040002/S018) | Endologix, LLC | 2008-10-08 |
| ON-X PROSTHETIC HEART VALVE (P000037/S015) | On-X Life Technologies, Inc. | 2008-10-03 |