| MICRONY PULSE GENERATORS (P970013/S002) | ABBOTT MEDICAL | 2001-10-25 |
| REGENCY SC+ PULSE GENERATORS (P880006/S034) | St. Jude Medical, Inc. | 2001-10-25 |
| MEDTRONIC GEM IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICD) (P900061/S048) | Medtronic Cardiac Rhythm Disease Management | 2001-10-24 |
| MEDTRONIC JEWEL AF ICD (P980050/S009) | Medtronic, Inc. | 2001-10-24 |
| GEM DR, GEM II VR, GEM II DR, AND GEM III IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P980016/S022) | Medtronic Cardiac Rhythm Disease Management | 2001-10-24 |
| DEMA/DIVA IMPLANTABLE PULSE GENERATORS (P990001/S008) | Medtronic, Inc. | 2001-10-24 |
| INSYNC IMPLANTABLE PULSE GENERATORS, MODEL 8040 (P010015/S001) | Medtronic, Inc. | 2001-10-24 |
| MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS (P980035/S012) | Medtronic, Inc. | 2001-10-24 |
| KAPPA 400 IMPLANTABLE PULSE GENERATOR (P970012/S011) | Medtronic, Inc. | 2001-10-24 |
| TEROX RV /KAINOX SL IMPLANTABLE CARDIOVERTER DEFIBRILLATOR/LEAD MODELS (P980023/S005) | Biotronik, Inc. | 2001-10-24 |
| BIODIVYSIO AS OTW (P000011/S005) | Abbott Vascular, Inc. | 2001-10-22 |
| BETA-CATH(TM) SYSTEM (P000018/S013) | Best Vascular, Inc. | 2001-10-18 |
| BX VELOCITY STENT WITH HEPACOAT ON RAPTORRAIL STENT DELIVERY SYSTEM (RX) (P900043/S029) | Cordis Corp. | 2001-10-16 |
| CADENCE TIERED THERAPY DEFIBRILLATOR SYSTEM (P910023/S056) | ABBOTT MEDICAL | 2001-10-15 |
| HOME MONITORING SYSTEM (P950037/S019) | Biotronik, Inc. | 2001-10-11 |
| BIOTRONIK INOS2+ CLS PULSE GENERATOR AND B-K05.V.U PROGRAMMER SOFTWARE (P950037/S020) | Biotronik, Inc. | 2001-10-10 |
| GEM VR MODELS 7227 B/D/E/CX (P900061/S047) | Medtronic Cardiac Rhythm Disease Management | 2001-10-10 |
| STINGER SM ABLATION CATHETER (P000020/S004) | Boston Scientific Corp | 2001-10-10 |
| CVX-300 EXCIMER LASER CORONARY ANGIOPLASTY (ELCA) SYSTEM (P910001/S020) | Spectranetics Corp. | 2001-10-10 |
| RF CONTACTR ABLATION CATHETER (P930029/S015) | Medtronic, Inc. | 2001-10-09 |
| CLOSER/CLOSER S SMC 6 FRENCH SYSTEMS (P960043/S029) | Abbott Vascular, Inc. | 2001-10-09 |
| CELSIUS DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER (P950005/S010) | Biosense Webster, Inc. | 2001-10-05 |
| S7 WITH DISCRETE TECHNOLOGY (TM) OTW/RAPID EXCHANGE CORONARY STENT SYSTEM (P970035/S029) | Medtronic, Ireland | 2001-10-04 |
| LIVEWIRE TC(TM) CARDIAC ABLATION SYSTEM: BIDIRECTIONAL 4MM TIP (P960016/S007) | St Jude Medical | 2001-10-04 |
| S7/S670/S660/BESTENT WITH DISCRETE TECHNOLOGY (TM) RAPID EXCHANGE CORONARY STENT SYSTEM (P970035/S030) | Medtronic, Ireland | 2001-10-02 |
| INTEGRITY AFX DR MODEL 5346 (P830045/S078) | St. Jude Medical, Inc. | 2001-10-02 |
| 8F ANGIO-SEAL VASCULAR CLOSURE DEVICE (P930038/S032) | Terumo Medical Corporation | 2001-10-02 |
| INTEGRITY AFX DR MODEL 5346 (P880086/S085) | ABBOTT MEDICAL | 2001-10-02 |
| S7/S670/S660/BESTENT 2/ WITH DISCRETE TECHNOLOGY RAPID EXCHANGE CORONARY STENT DELIVERY SYSTEM (P000022/S008) | Medtronic Vascular | 2001-10-02 |
| PROFILE MD (MODELS V-186F AND V-186HV3), PHOTON DR (MODEL V-230HV) AND PHOTON U VR/DR IMPLANTABLE CARDIOVERTER (P910023/S055) | ABBOTT MEDICAL | 2001-10-02 |
| RAPTORAIL PTCA DILATATION CATHETER (P880003/S082) | Cordis Corp. | 2001-09-27 |
| NAVISTAR DEFLECTABLE TIP DIAGNOSTIC/ABLATION CATHETER (P990025/S002) | Biosense Webster, Inc. | 2001-09-26 |
| TVL LEAD SYSTEM (P950022/S013) | ABBOTT MEDICAL | 2001-09-26 |
| NOVOSTE (TM) BETA-CATH(TM) SYSTEM (P000018/S017) | Best Vascular, Inc. | 2001-09-26 |
| NIR STENT DELIVERY SYSTEMS (P980001/S038) | Boston Scientific Corp | 2001-09-26 |
| BESTENT (TM) 2 WITH DISCRETE TECHNOLOGY OTW/RAPID EXCHANGE CORONARY STENT DELIVERY SYSTEM (P000022/S007) | Medtronic Vascular | 2001-09-26 |
| BX VELOCITY/HEPACOAT ON RAPTOR STENT SYSTEM (P900043/S028) | Cordis Corp. | 2001-09-21 |
| BX VELOCITY STENT ON RAPTORRAIL STENT DELIVERY SYSTEM (P900043/S027) | Cordis Corp. | 2001-09-21 |
| ANCURE ENDOVASCULAR GRAFT TUBE AND BIFURCATED SYSTEMS (P990017/S011) | Boston Scientific Corp | 2001-09-20 |
| NIR PREMOUNTED STENT DELIVERY SYSTEMS (P980001/S037) | Boston Scientific Corp | 2001-09-20 |
| VASOSEAL ES AND VHD DEVICES (P920004/S015) | St. Jude Medical, Inc. | 2001-09-20 |
| EDP 30 EXTERNAL DUAL CHAMBER PACEMAKER (P950037/S021) | Biotronik, Inc. | 2001-09-10 |
| SCIMED PTCA CATHETERS (P860019/S176) | Scimed Life Systems, Inc. | 2001-09-07 |
| SCHNEIDER PTCA CATHETERS (P880027/S061) | Boston Scientific | 2001-09-07 |
| ROTABLATOR(R) ROTATIONAL ANGIOPLASTY SYSTEM CONSOLE AND DYNAGLIDE(TM)FOOT PEDAL (P900056/S064) | Boston Scientific Corp | 2001-09-07 |
| MODEL 3307 VERSION 2.4A PROGRAMMER SOFTWARE (P910023/S054) | ABBOTT MEDICAL | 2001-09-05 |
| MODEL 3307 VERSION 2.4A PROGRAMMER SOFTWARE (P830045/S077) | St. Jude Medical, Inc. | 2001-09-05 |
| MEDTRONIC GEM DR MODEL 7271 (P980016/S020) | Medtronic Cardiac Rhythm Disease Management | 2001-09-05 |
| MEDTRONIC MODEL 5719 ACTIVE CAN EMULATOR (ACE) MODEL 5460 ACE HEADER (P900061/S046) | Medtronic Cardiac Rhythm Disease Management | 2001-09-05 |
| MODEL 3307 VERSION 2.4A PROGRAMMER SOFTWARE (P880086/S084) | ABBOTT MEDICAL | 2001-09-05 |
| TACHOS DR IMPLANTALBLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM (P000009/S002) | Biotronik, Inc. | 2001-09-04 |
| MEDTRONIC MODEL 7250 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM (AF ONLY STUDY) (P980050/S006) | Medtronic, Inc. | 2001-08-29 |
| ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLATFORM (P930038/S031) | Terumo Medical Corporation | 2001-08-28 |
| MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEM (P010015) | Medtronic, Inc. | 2001-08-28 |
| PERCUTANEOUS CORONARY DILATATION CATHETERS (P810046/S209) | Advanced Cardiovascular Systems, Inc. | 2001-08-22 |
| NOVOSTE(TM) BETA-CATH(TM) SYSTEM (P000018/S011) | Best Vascular, Inc. | 2001-08-22 |
| MEDTRONIC SIGMA/MEDTRONIC 350 SERIES PULSE GENERATORS PRODUCTS (P980035/S011) | Medtronic, Inc. | 2001-08-22 |
| NIR PREMOUNTED STENT SYSTEMS (P980001/S036) | Boston Scientific Corp | 2001-08-21 |
| BARD STINGER ABLATION CATHETERS (P000020/S003) | Boston Scientific Corp | 2001-08-20 |
| ANCURE ENDOGRAFT SYSTEM (P990017/S025) | Boston Scientific Corp | 2001-08-17 |
| ANCURE(R) ENDOGRAFT(R) SYSTEM (P990017/S020) | Boston Scientific Corp | 2001-08-17 |
| ANCURE ENDOGRAFT SYSTEM (P990017/S015) | Boston Scientific Corp | 2001-08-17 |
| ENDOVASCULAR SOLUTIONS ANCURE ENDOGRAFT SYSTEM (P990017/S027) | Boston Scientific Corp | 2001-08-17 |
| ANCURE ENDOGRAFT SYSTEM (P990017/S023) | Boston Scientific Corp | 2001-08-17 |
| ANCURE ENDOGRAFT SYSTEM (P990017/S021) | Boston Scientific Corp | 2001-08-17 |
| ANCURE ENDOGRAFT SYSTEM (P990017/S016) | Boston Scientific Corp | 2001-08-17 |
| ANCURE ENDOGRAFT SYSTEM (P990017/S017) | Boston Scientific Corp | 2001-08-17 |
| ANCURE ENDOGRAFT SYSTEM (P990017/S022) | Boston Scientific Corp | 2001-08-17 |
| ANCURE ENDOGRAFT SYSTEM (P990017/S026) | Boston Scientific Corp | 2001-08-17 |
| SCIMED MAGIC WALLSTENT ENDOPROSTHESIS WITH DELIVERY SYSTEM (P980009/S009) | Boston Scientific Scimed, Inc. | 2001-08-16 |
| MAGIC WALLSTENT(R) ENDOPROSTHESIS WITH DELIVERY SYSTEM (P980009/S008) | Boston Scientific Scimed, Inc. | 2001-08-16 |
| MAGIC WALLSTENT ENDOPROSTHESIS WITH DELIVERY SYSTEM (P980009/S007) | Boston Scientific Scimed, Inc. | 2001-08-16 |
| NIR CORONARY STENT WITH DELIVERY SYSTEM (P980001/S035) | Boston Scientific Corp | 2001-08-16 |
| CLOSER / CLOSER S PERCUTANEOUS VASCULAR SURGERY DEVICES (P960043/S032) | Abbott Vascular, Inc. | 2001-08-15 |
| MULTI-LINK FAMILY OF CORONARY STENT SYSTEMS (P970020/S034) | Abbott Vascular, Inc. | 2001-08-14 |
| SCIMED PTCA CATHETERS (P860019/S175) | Scimed Life Systems, Inc. | 2001-08-14 |
| RADIUS CORONARY STENT WITH DELIVERY SYSTEM (P970061/S011) | Boston Scientific Scimed, Inc. | 2001-08-13 |
| SCIMED TIPS WALLSTENT SYSTEM (P930031/S010) | Boston Scientific Corp | 2001-08-13 |
| ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S066) | Boston Scientific Corp | 2001-08-13 |
| ILIAC WALLSTENT SYSTEM (P940019/S008) | Boston Scientific Scimed, Inc. | 2001-08-13 |
| MEDTRONIC PACING LEADS (P830061/S032) | Medtronic Cardiac Rhythm Disease Management | 2001-08-08 |
| MEDTRONIC PACING LEADS (P850089/S047) | Medtronic Cardiac Rhythm Disease Management | 2001-08-08 |
| MEDTRONIC MODEL 7250 ARRHYTHMIA MANAGEMENT DEVICE (P980050/S007) | Medtronic, Inc. | 2001-08-08 |
| CAPSUREFIX (R) (P930039/S010) | Medtronic, Inc. | 2001-08-08 |
| GEM DR/GEM II DR/GEM II VR (P980016/S019) | Medtronic Cardiac Rhythm Disease Management | 2001-08-08 |
| MICRO JEWEL/JEWEL II (P900061/S045) | Medtronic Cardiac Rhythm Disease Management | 2001-08-08 |
| MEDTRONIC PACING LEADS (P890003/S064) | Medtronic, Inc. | 2001-08-08 |
| MEDTRONIC (R) CAPSURE (R) EPI PACING LEAD MODEL 4695 (P950024/S004) | Medtronic, Inc. | 2001-08-08 |
| MODEL 6726 DF-1-Y-ADAPTOR/EXTENDER KIT (P920015/S023) | Medtronic, Inc. | 2001-08-08 |
| VASOSEAL ES DEVICE (P920004/S013) | St. Jude Medical, Inc. | 2001-08-03 |
| NOVOSTE(TM) BETA-CATH(TM) SYSTEM (P000018/S012) | Best Vascular, Inc. | 2001-08-01 |
| BOSTON SCITNTIFIC SCIMED AORTIC VALVULOPLASTY(TM) CATHETER (P880065/S006) | Boston Scientific Corp | 2001-07-30 |
| BOSTON SCINTIFIC SCIMED PTCA CATHETER (P880027/S060) | Boston Scientific | 2001-07-30 |
| CORDIS CHECKMATE(TM) SYSTEM (P990036/S002) | Cordis Corp. | 2001-07-27 |
| ANGIO-SEAL VASCULAR CLOSURE DEVICE:SELF-TIGHTENING SLIPKNOT(STS) (P930038/S029) | Terumo Medical Corporation | 2001-07-26 |
| OMNICARBON CARDIAC VALVE PROSTHESIS (P830039/S007) | Medical Cv, Inc. | 2001-07-26 |
| PROFILE(TM) MD (MODELS V-186F AND V-186HV3), PHOTON(TM) DR (MODEL V-230HV) AND PHOTON(TM) U VR/DR IMPLANTABLE CARDIOVER) (P910023/S053) | ABBOTT MEDICAL | 2001-07-18 |
| ROTABLATOR(R) ROTATIONAL ANGIOPLASTY SYSTEM, TOTABLATOR LASER WELDING PROCESS (P900056/S065) | Boston Scientific Corp | 2001-07-16 |
| BETA-CATH(TM) SYSTEM (P000018/S014) | Best Vascular, Inc. | 2001-07-13 |
| BELOS VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM (P980023/S004) | Biotronik, Inc. | 2001-07-12 |