| INTEGRITY AFX DR MODEL 5346 DUAL CHAMBER PULSE (P830045/S076) | St. Jude Medical, Inc. | 2001-07-11 |
| INTEGRITY AFX DR MODEL 5346 DUAL CHAMBER PULSE GENERATOR AND PROGRAMMER SOFTWARE MODEL 3307, V2.2A (P880086/S083) | ABBOTT MEDICAL | 2001-07-11 |
| MODEL 6943 SPRINT(R) LEAD (P980050/S005) | Medtronic, Inc. | 2001-07-11 |
| TALENT PULSE GENERATOR MODELS DR233 AND SR 133 AND PROGRAMMER SOFTWARE CSO 4.18 UG (P950029/S014) | MicroPort CRM USA, Inc. | 2001-07-03 |
| BIODIVYSIO AS OTW (P000011/S002) | Abbott Vascular, Inc. | 2001-07-03 |
| CELSIUS DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER (P950005/S011) | Biosense Webster, Inc. | 2001-06-27 |
| VENTAK PRIZM DR/VR AND VENTAK PRIZM DR/VR HE ACID SYSTEMS (P960040/S023) | Boston Scientific | 2001-06-27 |
| CELSIUS/CELSIUS II DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS AND TEMPERATURE CABLES (P950005/S014) | Biosense Webster, Inc. | 2001-06-27 |
| CELSIUS II BIDIRECTIONAL DEFLECTING DIAGNOSTIC/ABLATION CATHETER (P950005/S013) | Biosense Webster, Inc. | 2001-06-22 |
| BONNIE & BYPASS SPEEDY PTCA CATHETER (P880027/S059) | Boston Scientific | 2001-06-21 |
| VITESSE POINT 9 MM X80 & EXTREME POINT 9MM X80 PERCUTANEOUS CORONARY ANGIOPLASTY CATHETER, MODELS 110-004 AND 110-002 (P910001/S019) | Spectranetics Corp. | 2001-06-19 |
| NOVOSTE 40 MM BETA-CATH SYSTEM (P000018/S005) | Best Vascular, Inc. | 2001-06-15 |
| MODEL 6726 DF-1-Y-ADAPTOR/EXTENDER KIT (P920015/S022) | Medtronic, Inc. | 2001-06-15 |
| LIVEWIRE TC COMPASS STEERABLE ELECTROPHYSIOLOGY CATHETER (P960016/S004) | St Jude Medical | 2001-06-14 |
| CAPSURE SP NOVUS LEAD MODEL 5594 (P850089/S046) | Medtronic Cardiac Rhythm Disease Management | 2001-06-14 |
| VASCULAR SOLUTIONS DUETT SEALING DEVICE (P990037/S006) | Vascular Solutions, Inc. | 2001-06-14 |
| ATS OPEN PIVOT BILEAFLET HEART VALVE (P990046/S004) | Medtronic Ats Medical, Inc. | 2001-06-14 |
| MODEL 2725 VENTAK PRIZM DIAGNOSTIC/RESTORATION TOOL (P960040/S022) | Boston Scientific | 2001-06-13 |
| PHOTON MICRO(U) DR/VR MODELS V-232/V-194 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM WITH MODEL 3307 PROGRAMMER SOFTW3 (P910023/S052) | ABBOTT MEDICAL | 2001-06-13 |
| MODEL 6996 SQ LEAD SYSTEM AND 6996T TUNNELING TOOL (P920015/S021) | Medtronic, Inc. | 2001-06-11 |
| ORCHESTRA PROGRAMMER (P980049/S005) | MicroPort CRM USA, Inc. | 2001-06-08 |
| NIR(R) PREMOUNTED STENT SYSTEM (P980001/S033) | Boston Scientific Corp | 2001-06-07 |
| ANCURE(R) ENDOGRAFT(R) SYSTEM (P990017/S024) | Boston Scientific Corp | 2001-06-07 |
| MEDTRONIC MOSAIC PORCINE BIOPROSTHESES MODEL 305 (AORTIC) AND MODEL 310 (MITRAL) (P990064/S004) | Medtronic, Inc. | 2001-06-07 |
| ACS MULTI-LINK RX/OTW DUET(TM) CORONARY STENT SYSTEM - REVIVE REGISTRY (P970020/S031) | Abbott Vascular, Inc. | 2001-06-05 |
| BESTENT 2 WITH DISCRETE TECHNOLOGY OTW/RX CORONARY STENT DELIVERY SYSTEMS (P000022/S006) | Medtronic Vascular | 2001-06-05 |
| CORONARY DILATATION CATHETER (P810046/S208) | Advanced Cardiovascular Systems, Inc. | 2001-06-05 |
| NC MAXXUM PTCA CATHETER (P860019/S168) | Scimed Life Systems, Inc. | 2001-06-04 |
| R2L RAPID EXCHANGE BALLOON DILATATION CATHETER WITH EXTENDED PRESSURE RANGE AND D2L OVER-THE-WIRE BALLOON DILATATION CAT (P790017/S075) | Medtronic, Ireland | 2001-06-01 |
| MULTI-LINK FAMILY OF CORONARY STENT SYSTEMS (P970020/S033) | Abbott Vascular, Inc. | 2001-06-01 |
| ACS MULTI-LINK RX AND OTW PIXEL CORONARY STENT SYSTEMS (P970020/S030) | Abbott Vascular, Inc. | 2001-06-01 |
| THORATEC VENTRICULAR ASIST DEVICE (P870072/S012) | Thoratec Laboratories Corp. | 2001-06-01 |
| HEARTMATE XVE LVAS (P920014/S015) | Thoratec Corp | 2001-05-31 |
| ON-X (R) PROSTHETIC HEART VALVE, MODEL ONXA (P000037) | On-X Life Technologies, Inc. | 2001-05-30 |
| S7 WITH DIS OVER-THE WIRE CORONARY STENT SYSTEM AND S7 WITH DISCRETE TECHN RAPID EXCHANGE CORONARY STENT SYSTEM (P970035/S027) | Medtronic, Ireland | 2001-05-29 |
| NIR PREMOUNTED STENT SYSTEMS (P980001/S032) | Boston Scientific Corp | 2001-05-29 |
| WALLSTENT(R) ILLIAC ENDOPROSTHESIS (P940019/S007) | Boston Scientific Scimed, Inc. | 2001-05-29 |
| WALLSTENT(R) TRANSJUGLAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) ENDOPROSTHESIS (P930031/S009) | Boston Scientific Corp | 2001-05-29 |
| MEDTRONIC. GEM MODEL 7227CX, GEM III DR MODEL 7275, GEM III VR MODEL 7231 AND GEM III AT MODEL 7276 (P980016/S016) | Medtronic Cardiac Rhythm Disease Management | 2001-05-25 |
| MEDTRONIC. GEM MODEL 7227CX, GEM III DR MODEL 7275, GEM III VR MODEL 7231 AND GEM III AT MODEL 7276 (P980050/S003) | Medtronic, Inc. | 2001-05-25 |
| MEDTRONIC GEM MODEL 7227CX, GEM III DR MODEL 7275, GEM III VR MODEL 7231 AND GEM III AT MODEL 7276 (P900061/S042) | Medtronic Cardiac Rhythm Disease Management | 2001-05-25 |
| PTCA CATHETERS (P860019/S174) | Scimed Life Systems, Inc. | 2001-05-25 |
| CELSIUS/CELSIUS II DIAGNOSTIC ABLATION DEFLECTABLE TIP CATHETER (P950005/S012) | Biosense Webster, Inc. | 2001-05-25 |
| ACTROS AND KAIROS FAMILY OF PULSE GENERATORS WITH LITRONIK BATTERY (P950037/S017) | Biotronik, Inc. | 2001-05-24 |
| HIGHSAIL CORONARY DILATATION CATHETER (P810046/S207) | Advanced Cardiovascular Systems, Inc. | 2001-05-24 |
| ACS MULTI-LINK RX/OTW ULTRA CORONARY STENT SYSTEMS (P970020/S032) | Abbott Vascular, Inc. | 2001-05-24 |
| MEDTRONIC MODEL 7276 GEM III AT IMPLANTABLE DEFIBRILLATOR (P980050/S004) | Medtronic, Inc. | 2001-05-22 |
| ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S063) | Boston Scientific Corp | 2001-05-21 |
| STINGER(TM) AND STINGER S(TM) ABLATION CATHETER AND TEMPLINK(TM) EXTENSION CABLE (P000020/S001) | Boston Scientific Corp | 2001-05-18 |
| NC MONORAIL PTCA CATHETER (P860019/S173) | Scimed Life Systems, Inc. | 2001-05-16 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS MODEL 6900 MITRAL (P860057/S015) | Edwards Lifesciences, LLC | 2001-05-15 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P860057/S017) | Edwards Lifesciences, LLC | 2001-05-15 |
| GEM DR/GEM II DR/GEM II VR (P980016/S018) | Medtronic Cardiac Rhythm Disease Management | 2001-05-14 |
| MICRO JEWEL/JEWEL II (P900061/S044) | Medtronic Cardiac Rhythm Disease Management | 2001-05-14 |
| MEDTRONIC KAPPA 700/600 PULSE GENERATOR (P980035/S010) | Medtronic, Inc. | 2001-05-14 |
| ATS OPEN PIVOT BILEAFLET HEART VALVE (P990046/S001) | Medtronic Ats Medical, Inc. | 2001-05-10 |
| ATS OPEN PIVOT BILEAFLET HEART VALVE (P990046/S003) | Medtronic Ats Medical, Inc. | 2001-05-10 |
| ANEURX STENT GRAFT SYSTEM (P990020/S007) | Medtronic Vascular | 2001-05-09 |
| CUTTING BALLOON (P950020/S002) | Boston Scientific Corp | 2001-05-08 |
| MULTI-LINK RX/OTW PENTA CORONARY STENT SYSTEM (P970020/S027) | Abbott Vascular, Inc. | 2001-05-07 |
| 9767/9767L PROGRAMMING HEAD AND MODEL9990 DESKTOP SOFTWARE (P890003/S063) | Medtronic, Inc. | 2001-05-07 |
| BIODIVYSIOI AS PC (PHOSPHORYLCHOLINE) COATED STENT AND DELIVERY SYSTEM (P000011/S001) | Abbott Vascular, Inc. | 2001-05-07 |
| MEDTRONIC REVEAL PLUS INSERTABLE LOOP RECORDER (ILR) WITH UPDATED TO THE APPLICATION SOFTWARE (MODEL 09-9 SERIES 2.0) (P890003/S062) | Medtronic, Inc. | 2001-05-07 |
| S670 WITH D OVER-THE-WIRE AND RAPID EXCHANGE CORONARY STENT SYSTEMS, S660 WITH DISCRETE TECH OVER-THE-WIRE AND RAPID EXS (P970035/S026) | Medtronic, Ireland | 2001-05-03 |
| BESTENT(TM) 2 WITH DISCRETE TECHNOLOGY(TM) RAPID EXCHANGE CORONARY STENT SYSTEMS (P000022/S005) | Medtronic Vascular | 2001-05-03 |
| MECHANICAL HEART VALVE, MASTERS SERIES COATED AORTIC VALVED GRAFT, MODEL CAVGJ-514 00 (P810002/S056) | ABBOTT MEDICAL | 2001-05-03 |
| PTCA CATHETER (P860019/S172) | Scimed Life Systems, Inc. | 2001-05-02 |
| PTCA CATHETERS (P860019/S171) | Scimed Life Systems, Inc. | 2001-05-01 |
| MICRONY II SR MODEL 2525T/MICRONY K SR MODEL 2535K PULSE GENERATORS (P970013/S001) | ABBOTT MEDICAL | 2001-04-30 |
| VIGOR SOFTWARE APPLICATION; VERSION 5.2 (P840068/S041) | Boston Scientific | 2001-04-30 |
| VIGOR SOFTWARE APPLICATION; VERSION 5.2 (P940031/S026) | Boston Scientific | 2001-04-30 |
| INTERMEDICS MICRON IMPLANTABLE DEFIBRILLATORS (P940008/S016) | Boston Scientific | 2001-04-25 |
| BETA-CATH(TM) SYSTEM (P000018/S003) | Best Vascular, Inc. | 2001-04-24 |
| EPT-1000 CARDIAC ABLATION SYSTEM (P920047/S014) | Boston Scientific Corp | 2001-04-24 |
| PREMIER PACING SYSTEM (P850051/S056) | Medtronic, Inc. | 2001-04-18 |
| ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM GUIDE WIRES (P900056/S062) | Boston Scientific Corp | 2001-04-17 |
| ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S061) | Boston Scientific Corp | 2001-04-13 |
| OPEN SAIL CORONARY DILATATION CATHETER (P810046/S206) | Advanced Cardiovascular Systems, Inc. | 2001-04-13 |
| NIROYAL(R) ELITE OVER-THE-WIRE STENT SYSTEM (P980001/S031) | Boston Scientific Corp | 2001-04-10 |
| NIROYAL(R) ELITE OVER-THE-WIRE STENT SYSTEM (P980001/S030) | Boston Scientific Corp | 2001-04-10 |
| MODEL4553 MICRO-PACE,DUAL-CHAMBER,DDD TEMPORARY CARDIAC PACEMAKER (P920032/S006) | Pace Medical | 2001-04-06 |
| FLEXI-CUT DIRECTIONAL DEBULKING SYSTEM (P890043/S035) | Abbott Vascular | 2001-04-06 |
| BX VELOCITY STENT ON RAPTOR RAIL STENT DELIVERY SYSTEM (RX) (P900043/S026) | Cordis Corp. | 2001-04-06 |
| THINLINE II/FINELINE II STEROX PACING LEADS (P960004/S018) | Boston Scientific | 2001-04-06 |
| JEWEL AF SYSTEM (P980050/S001) | Medtronic, Inc. | 2001-04-06 |
| MAVERICK MONORAIL (P860019/S170) | Scimed Life Systems, Inc. | 2001-04-05 |
| VENTAK PRIZM IMPLANTABLE CARIOVERTER DEFIBRILLATORS (P960040/S021) | Boston Scientific | 2001-04-05 |
| S7 WITH DISCRETE TECHNOLOGY(TM) OVER-THE-WIRE/RAPID EXCHANGE CORONARY STENT SYSTEM (P970035/S022) | Medtronic, Ireland | 2001-04-04 |
| AORTIC VALVULOPLASTY BALLOON DILATATION CATHETER (P880065/S005) | Boston Scientific Corp | 2001-03-27 |
| PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) (P880027/S058) | Boston Scientific | 2001-03-27 |
| RADIUS(TM) CORONARY STENT WITH DELIVERY SYSTEM (P970061/S010) | Boston Scientific Scimed, Inc. | 2001-03-27 |
| PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) (P860019/S169) | Scimed Life Systems, Inc. | 2001-03-27 |
| NIR(R) PREMOUNTED STENT DELIVERY SYSTEMS (P980001/S029) | Boston Scientific Corp | 2001-03-27 |
| VASCULAR SOLUTIONS DUETT MODEL 1000 SEALING DEVICE (P990037/S003) | Vascular Solutions, Inc. | 2001-03-22 |
| ROTABLATOR(R) ROTALINK ROTATIONAL ANGIOPLASTY SYSTEM AND ROTALINK(TM) PLUS WITH EXCHANGEABLE CATHETER (P900056/S060) | Boston Scientific Corp | 2001-03-21 |
| S670 AND S660 WITH DISCRETE TECHNOLOGY CORONARY STENT SYSTEMS (P970035/S025) | Medtronic, Ireland | 2001-03-19 |
| DISCRETE TECHNOLOGY(TM)OVER-THE-WIRE/RAPID EXCHANGE CORONARY STENT SYSTEM (P970035/S024) | Medtronic, Ireland | 2001-03-19 |
| BESTENT 2 WITH DISCRETE TECHNOLOGY(TM) OVER-THE-WIRE AND RAPID EXCHANGE CORONARY STENT SYSTEMS (P000022/S004) | Medtronic Vascular | 2001-03-19 |
| SJM MECHANICAL HEART VALVE, MASTER SERIES COATED AORTIC VALVED GRAFT (P810002/S055) | ABBOTT MEDICAL | 2001-03-16 |
| MAGIC WALLSTENT ENDOPROSTHESIS (P980009/S006) | Boston Scientific Scimed, Inc. | 2001-03-16 |