| RES-Q(TM) MICRON ICD SYSTEM (P940008/S005) | Boston Scientific | 1997-04-25 |
| SCIMED(R)REBEL(TM) PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER (P860019/S118) | Scimed Life Systems, Inc. | 1997-04-24 |
| TVL(TM) LEAD SYSTEM (P950022/S001) | ABBOTT MEDICAL | 1997-04-23 |
| ELIPSE 14,000.014 CORONARY DILATATION CATHETER (P810046/S168) | Advanced Cardiovascular Systems, Inc. | 1997-04-21 |
| TX-2000 (P810046/S173) | Advanced Cardiovascular Systems, Inc. | 1997-04-21 |
| THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM (P870072/S003) | Thoratec Laboratories Corp. | 1997-04-17 |
| CADENCE(R) TIERED THERAPY DEFIBRILLATOR SYSTEM (P910023/S023) | ABBOTT MEDICAL | 1997-04-17 |
| RX5000 (TM) GRAPHICS PROGRAMMER (P830026/S070) | Boston Scientific | 1997-04-17 |
| ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM (P900023/S021) | Abiomed Cardiovascular, Inc. | 1997-04-16 |
| VASOSEAL (TM) (P920004/S006) | St. Jude Medical, Inc. | 1997-04-15 |
| WALLSTENT TIPS ENDOPROSTHESIS (P930031/S004) | Boston Scientific Corp | 1997-04-15 |
| WALLSTENT(R) ILIAC ENDOPROSTHESIS (P940019/S002) | Boston Scientific Scimed, Inc. | 1997-04-14 |
| SCIMED TRANSPORT CORONARY BALLOON DILATATION-INFUSION CATHETER (P860019/S113) | Scimed Life Systems, Inc. | 1997-04-09 |
| FACT(TM)AND ARC BALLOON CORNARY DILATATION CATHETERS (P910031/S011) | Abbott Vascular Devices | 1997-04-09 |
| MEDTRONIC(R) HALL PROSTHETIC HEART VALVE (P790018/S028) | Medtronic Cardiac Surgery | 1997-04-07 |
| ACS TX2000 VP CORONARY DILITATION CATHETER (P810046/S172) | Advanced Cardiovascular Systems, Inc. | 1997-04-07 |
| MEDTRONIC MODEL 5388 TEMPORARY PACEMAKER (P820003/S072) | Medtronic Cardiac Rhythm Disease Management | 1997-03-27 |
| OMNISCEINCE CARDIAC VALVE PROSTHESIS EXTENSION OF SHELF LIFE (P830039/S006) | Medical Cv, Inc. | 1997-03-26 |
| VIGOR MODEL 2880 SOFTWARE APPLICATION (REV 3.0) (P840068/S031) | Boston Scientific | 1997-03-25 |
| VIGOR MODEL 2880 SOFTWARE APPLICATION (REV 3.0) (P940031/S008) | Boston Scientific | 1997-03-25 |
| MEDTRONIC(R) HALL PROSTHETIC HEART VALVE (P790018/S029) | Medtronic Cardiac Surgery | 1997-03-17 |
| PALMAZ-SCHATZ(TM) BALLOON EXPANDABLE STENT WITH DELIVERY SYSTEM (P900043/S005) | Cordis Corp. | 1997-03-13 |
| MEDTRONIC ARRHYTHMIA MANAGEMENT DEVICES INCLUDING MODEL 7221B/CX/D/E MICRO JEWEL DEVICE USED WITH CPI ENDOTAK (P900061/S031) | Medtronic Cardiac Rhythm Disease Management | 1997-03-13 |
| TRILOGY SR+ MODEL 2260L & 2264L CARDIAC PULSE GENERATORS WITH THE MODEL 3023 PDX FUNCTION PACK (P880086/S039) | ABBOTT MEDICAL | 1997-03-12 |
| E P TECH EPT-1000 CARDIAC ABLATION SYSTEM (P920047/S006) | Boston Scientific Corp | 1997-03-12 |
| CHORUS RM MODEL 7034 DDDR PACEMAKER INCL. OPUS RM MODEL 4534 SSIR PACEMAKER (P950029) | MicroPort CRM USA, Inc. | 1997-03-10 |
| MEDTRONIC ARRHYTHMIA MANAGEMENT DEVICES INCLUDING MODEL 7221B/CX/D/E MICRO JEWEL DEVICE USED WITH CPI ENDOTAK (P900061/S029) | Medtronic Cardiac Rhythm Disease Management | 1997-03-07 |
| CARBO-SEAL ASCENDING AORTIC PROSTHESIS (AAP) (P900060/S012) | Corcym S.r.l. | 1997-03-07 |
| MEDTRONIC CAPSURE(R) SP MODEL 5024M/5524M PACING LEADS (P850089/S035) | Medtronic Cardiac Rhythm Disease Management | 1997-03-07 |
| MEDTRONIC(R) EVERGREEN(TM) CORONARY BALLOON DILATATION CATHETERS (P870036/S041) | Medtronics Interventional Vascular | 1997-03-07 |
| MEDTRONIC ARRHYTHMIA MANAGEMENT DEVICES INCLUDING MODEL 7221B/CX/D/E MICRO JEWEL DEVICE USED WITH CPI ENDOTAK (P900061/S030) | Medtronic Cardiac Rhythm Disease Management | 1997-03-06 |
| CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM (P910023/S015) | ABBOTT MEDICAL | 1997-03-03 |
| CADENCE(R) TIERED THERAPY DEFIBRILLATOR SYSTEM (P910023/S025) | ABBOTT MEDICAL | 1997-03-03 |
| USCI(R)PROCROSS(TM) OVER THE WIRE BALLON DILATATION CATHETERT WITH RELY TM BALLOON MATERIAL AND HYDRO/PEL (P790017/S061) | Medtronic, Ireland | 1997-03-03 |
| RES-Q(TM) MICRON ICD SYSTEM (P940008/S004) | Boston Scientific | 1997-02-28 |
| ARC(TM) BALLOON CORONARY DILATATION CATHETERS (P910031/S012) | Abbott Vascular Devices | 1997-02-27 |
| ASUKA(TM) AND ASUKA(TM) LONGY PTCA CATHETERS (P880027/S043) | Boston Scientific | 1997-02-19 |
| GOLDIE TM AND GOLDIE TM LONGY PTCA CATHETERS (P880027/S044) | Boston Scientific | 1997-02-19 |
| VIGOR(R) DR/SR PACEMAKER SYSTEM (P940031/S009) | Boston Scientific | 1997-02-18 |
| DELTA(R) PACEMAKER SYSTEM (VIGOR SSI AND DDD MODELS ONLY) (P840068/S032) | Boston Scientific | 1997-02-18 |
| VENTAK PRX AICD SYSTEM (P910077/S020) | Boston Scientific | 1997-02-18 |
| ROTABLATOR(R) ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK(TM) (P900056/S018) | Boston Scientific Corp | 1997-02-13 |
| TITAN MEGA AND TITAN MEGA XL (P880003/S064) | Cordis Corp. | 1997-02-10 |
| MARATHON PACING SYSYTEM (P910020/S017) | Boston Scientific | 1997-02-10 |
| MEDTRONIC(R) LEGEND PLUS(TM) PULSE GENERATOR (P930022) | Medtronic, Inc. | 1997-02-07 |
| CAPSURE(R) AND CAPSURE(R) SP SILICONE PACING LEADS (P850089/S036) | Medtronic Cardiac Rhythm Disease Management | 1997-02-04 |
| USCI(R) PROBE III(TM) BALLOON-ON-A-WIRE(TM) D. SYS (P890048/S006) | Usci, Div. C.R. Bard, Inc. | 1997-02-04 |
| CAPSUREFIX(R) MODEL 4068 PACING LEAD (P930039/S003) | Medtronic, Inc. | 1997-02-04 |
| SCHNEIDER CHUBBY(TM) PTCA CATHETERS (P880027/S042) | Boston Scientific | 1997-02-04 |
| MODTRONIC(R) MODELS 7219/B/C/D/E AND 7202C/D/E (P900061/S021) | Medtronic Cardiac Rhythm Disease Management | 1997-02-04 |
| ACX RX COMET VP CORONARY DILATATION CATHETER (P810046/S169) | Advanced Cardiovascular Systems, Inc. | 1997-02-04 |
| PAS CHAMPION HP PTCA CATHETER (P930012/S005) | Progressive Angioplasty Systems, Inc. | 1997-01-29 |
| SCIMED(R) RANGER(TM) PERCUTANEOUS CORONARY ANGIOPLASTY (PTCA) CATHETER (P860019/S117) | Scimed Life Systems, Inc. | 1997-01-17 |
| THOR PTCA DILATION CATHETERS (P880003/S061) | Cordis Corp. | 1997-01-17 |
| LEOCOR SABLE(TM) PTCA CATHETER (P890001/S020) | Leocor, Inc. | 1997-01-16 |
| VIGOR(TM) DR PACEMAKER SYSTEM (P940031/S007) | Boston Scientific | 1997-01-14 |
| TRILOGY DC + PULSE GENERATOR, MODEL 2318L (P880086/S040) | ABBOTT MEDICAL | 1997-01-10 |
| ACS CONCORDE CORONARY DILATATION CATHETER (QUARTER SIZE DIAMETER 30MM AND 40MM BALLON LENGTHS) (P810046/S167) | Advanced Cardiovascular Systems, Inc. | 1997-01-08 |
| VASOSEAL (TM) (P920004/S005) | St. Jude Medical, Inc. | 1997-01-07 |
| WALLSTENT(R) TIPS ENDOPROSTHESIS (P930031/S003) | Boston Scientific Corp | 1997-01-03 |
| MEDTRONIC(R) CAPSUREFIX MODEL 4067/4568/5067/5068/5568 PACING LEAD (P930039/S002) | Medtronic, Inc. | 1997-01-02 |
| ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM (P900023/S020) | Abiomed Cardiovascular, Inc. | 1996-12-31 |
| PALMAZ-SCHATZ(TM) BALLOON EXPANDABLE STENT WITH DELIVERY SYSTEM (P900043/S003) | Cordis Corp. | 1996-12-20 |
| META DDDR PACEMAKER PULSE GENERATORS MODELS 1256, 1256D, & 1256B (FORMERLY 1256R) (P900070/S006) | St. Jude Medical, Cardiac Rhythm Management Divisi | 1996-12-20 |
| VASOSEAL (TM) (P920004/S003) | St. Jude Medical, Inc. | 1996-12-18 |
| VENTAK P2 AICD MODEL 1625 & VENTAK P3 AICD MODELS 1630 AND 1635 (P930035/S006) | Boston Scientific | 1996-12-11 |
| HANCOCK MODIFIED ORIFICE II AORTIC BIOPROSTHESIS (P790007/S013) | Medtronic Heart Valves | 1996-12-10 |
| CARPENTIER-EDWARDS(R) PERICARDIAL BIOPROSTHESIS, MODEL 2700 (P860057/S003) | Edwards Lifesciences, LLC | 1996-12-06 |
| SENSOLOG(R) CARDIAC PACING SYSTEM (P880006/S022) | St. Jude Medical, Inc. | 1996-12-06 |
| CARPENTIER-EDWARDS(R) DURAFLEX(TM) LOW PRESSURE BIOPROSTHESIS, MODEL 6625-LP AND 6625-ESR-LP(BOTH MITRAL) (P870077/S002) | Edwards Lifesciences, LLC | 1996-12-06 |
| CARPENTIER-EDWARDS LOW PRESSURE BIOPROSTHESIS MODELS 2625 (AORTIC) AD 6625 (MITRAL) (P870056/S002) | Edwards Lifesciences, LLC | 1996-12-06 |
| VASOSEAL (TM) (P920004/S004) | St. Jude Medical, Inc. | 1996-12-02 |
| FACT(TM)AND ARC BALLOON CORNARY DILATATION CATHETERS (P910031/S010) | Abbott Vascular Devices | 1996-12-02 |
| TEMPO DR 2102 AND TEMP D 2902 (P900070/S015) | St. Jude Medical, Cardiac Rhythm Management Divisi | 1996-11-27 |
| USCI(R) PROBE III(TM) BALLOON-ON-A-WIRE(TM) D. SYS (P890048/S005) | Usci, Div. C.R. Bard, Inc. | 1996-11-26 |
| BIOTRONIK GEMNOS 04 AND GEMNOS TC O4 (P820076/S018) | Biotronik, Inc. | 1996-11-21 |
| VALOR AND VALOR XL PTCA DILATATION CATHETERS (P880003/S063) | Cordis Corp. | 1996-11-20 |
| PREVA ST DR MODEL 7078 AND THE PREVA D MODEL 7068 IMPLANTABLE PULSE GENERATORS, AND MODEL 9559 SOFTWARE (P890003/S048) | Medtronic, Inc. | 1996-11-19 |
| AFP PACING SYSTEM (P830045/S052) | St. Jude Medical, Inc. | 1996-11-19 |
| ACS RX COMET(TM) CORONARY DILATION CATHETER (P810046/S166) | Advanced Cardiovascular Systems, Inc. | 1996-11-18 |
| ATHEROCATH-BANTAM(TM) DIRECTIONAL CORONARY ATHERECTOMY SYSTEM (P890043/S031) | Abbott Vascular | 1996-11-18 |
| PAS CHAMPION(TM) CATHETER 30 MM LONG BALLOONS (P930012/S004) | Progressive Angioplasty Systems, Inc. | 1996-11-18 |
| ABBOTT IMX SA (P910077/S016) | Boston Scientific | 1996-11-18 |
| THINLINE ENDOCARDIAL PACING LEADS (P960004) | Boston Scientific | 1996-11-12 |
| SELUTE STEROID ELUTING ENDOCARDIAL LEAD MODELS 4185 & 4285 (P950001/S001) | Boston Scientific | 1996-11-12 |
| VIGOR MODEL 2880 SOFTWARE APPLICATION (P840068/S030) | Boston Scientific | 1996-11-12 |
| VENTAK(R) P MODEL 1600 (P890061/S012) | Boston Scientific | 1996-11-12 |
| BIPOLAR ENDOCARDIAL LEADS 0012/0013 BIPOLAR ENDOCARDIAL LEADS & POSITIVE FIXATION PROTECTED-HELIX BIPOLAR ENDOCAR. LEAD (P830060/S042) | Boston Scientific | 1996-11-12 |
| VENTAK PRX AICD,SYSTEM FOR THE RHYTHMLINE TM TRANSTELPHONIC INTERROGATION SYSTEM MINI HC AICD, VENTAK II AICD (P910077/S019) | Boston Scientific | 1996-11-12 |
| VIGOR(TM) DR PACEMAKER SYSTEM (P940031/S006) | Boston Scientific | 1996-11-12 |
| VENTAK P2 AICD MODEL 1625 & VENTAK P3 AICD MODELS 1630 AND 1635 (P930035/S007) | Boston Scientific | 1996-11-12 |
| ENDOTAK C LEAD, SQ PATCH LEAD, SQ LEAD ARRAY, DSP LEAD (P910073/S021) | Boston Scientific | 1996-11-12 |
| CADENCE(R) TIERED THERAPY DEFIBRILLATOR SYSTEM (P910023/S022) | ABBOTT MEDICAL | 1996-11-08 |
| MEDTRONIC MODEL 7223CX MICRO JEWEL II(TM) (P900061/S024) | Medtronic Cardiac Rhythm Disease Management | 1996-11-08 |
| MODEL 2901 PROGRAMMER (P910077/S014) | Boston Scientific | 1996-11-07 |
| VIGOR MODEL 2880 SOFTWARE APPLICATION (P840068/S029) | Boston Scientific | 1996-11-07 |
| MAXIM PFS MODEL 033-301 (P920011) | St. Jude Medical, Cardiac Rhythm Management Divisi | 1996-11-07 |
| MODEL 2901 PROGRAMMERR SYSTEM (P940031/S005) | Boston Scientific | 1996-11-07 |
| VALOR AND VALOR XL PTCA DILATATION CATHETERS (P880003/S062) | Cordis Corp. | 1996-11-07 |
| ACS RX STREAK & ACS FLOW TRACK 40 (P810046/S162) | Advanced Cardiovascular Systems, Inc. | 1996-11-05 |