| BONNIE (TM) PTCA CATHERS (P880027/S050) | Boston Scientific | 1997-10-24 |
| ADDITION OF ALTERNATE TUBING EXTRUDER (P960004/S002) | Boston Scientific | 1997-10-23 |
| BONNIE (TM) PTCA CATHERS (P880027/S051) | Boston Scientific | 1997-10-23 |
| ST. JUDE MEDICAL MECHANICAL HEART VALVE (P810002/S044) | ABBOTT MEDICAL | 1997-10-20 |
| TEMPO PULSE GENERATORS (P900070/S021) | St. Jude Medical, Cardiac Rhythm Management Divisi | 1997-10-16 |
| BONNIE (TM) PTCA CATHERS (P880027/S048) | Boston Scientific | 1997-10-09 |
| APS III MODEL 3500 PROGRAMMER (P830045/S054) | St. Jude Medical, Inc. | 1997-10-07 |
| APS III MODEL 3500 PROGRAMMER (P880086/S041) | ABBOTT MEDICAL | 1997-10-07 |
| MODEL 1256D META MV CARDIAC PULSE GENERATOR (P900070/S020) | St. Jude Medical, Cardiac Rhythm Management Divisi | 1997-10-07 |
| TAPSYSTEM 2A (P840002/S007) | Cardiocommand, Inc. | 1997-10-03 |
| MULTI-LINK ULTRA/ ZETA CORONARY STENT SYSTEMS (P970020) | Abbott Vascular, Inc. | 1997-10-02 |
| MONOSTRUT CARDIAC VALVE PROSTHESIS (P970002) | Alliance Medical Technologies, Inc. | 1997-09-30 |
| SCIMED(R) RANGER(TM) PERCUTANEOUS CORONARY ANGIOPLASTY (PTCA) CATHETER (P860019/S128) | Scimed Life Systems, Inc. | 1997-09-30 |
| WEBSTER DIAG./ABLATION DEFLECTABLE TIP CATHETER (P950005) | Biosense Webster, Inc. | 1997-09-30 |
| MEDTRONIC(R) HALL PROSTHETIC HEART VALVE (P790018/S030) | Medtronic Cardiac Surgery | 1997-09-29 |
| ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM (P900023/S024) | Abiomed Cardiovascular, Inc. | 1997-09-26 |
| VITESSE TM -E (ECCENTRIC MONORAIL) CATHETER MODEL 120-008 (P910001/S012) | Spectranetics Corp. | 1997-09-24 |
| ACS RX ESPRIT (P810046/S177) | Advanced Cardiovascular Systems, Inc. | 1997-09-19 |
| SELUTE STEROID ELUTING ENDOCARDIAL LEAD MODELS 4185 & 4285 (P950001/S002) | Boston Scientific | 1997-09-19 |
| ENDOTAK C LEAD, SQ PATCH LEAD, SQ LEAD ARRAY, DSP LEAD (P910073/S022) | Boston Scientific | 1997-09-19 |
| ANGIO-SEAL(TM)[1] HEMOSTATIC PUNCTURE CLOSURE DEVICE (P930038/S001) | Terumo Medical Corporation | 1997-09-17 |
| CADENCE(R) TIERED THERAPY DEFIBRILLATOR SYSTEM (P910023/S027) | ABBOTT MEDICAL | 1997-09-15 |
| VASOSEAL (TM) (P920004/S007) | St. Jude Medical, Inc. | 1997-09-15 |
| SCIMED(R) RANGER(TM) PERCUTANEOUS CORONARY ANGIOPLASTY (PTCA) CATHETER (P860019/S121) | Scimed Life Systems, Inc. | 1997-09-12 |
| SPL LEAD SYSTEM (P950022/S002) | ABBOTT MEDICAL | 1997-09-11 |
| MODEL 6943 AND 6945 (P920015/S013) | Medtronic, Inc. | 1997-09-10 |
| MANSFIELD SCI. AORTIC VALVULOPLASTY CATHETER (P880065/S003) | Boston Scientific Corp | 1997-09-08 |
| ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM (P900023/S023) | Abiomed Cardiovascular, Inc. | 1997-09-03 |
| STAT-PACE II ESOPHAGEAL PACING SYSTEM (P840002/S009) | Cardiocommand, Inc. | 1997-09-03 |
| THINLINE ENDOCARDIAL PACING LEADS (P960004/S001) | Boston Scientific | 1997-08-29 |
| TEMPO VR 1102 AND TEMPO V 1902 (P900070/S017) | St. Jude Medical, Cardiac Rhythm Management Divisi | 1997-08-27 |
| TEMPO DR 2102 AND TEMP D 2902 (P900070/S014) | St. Jude Medical, Cardiac Rhythm Management Divisi | 1997-08-27 |
| PROCROSS RELY SP PTCA CATHETER (P790017/S063) | Medtronic, Ireland | 1997-08-26 |
| RES-Q(TM) MICRON ICD SYSTEM (P940008/S006) | Boston Scientific | 1997-08-13 |
| ACS RX COMET CORONARY DILATATION CATHETER (P810046/S180) | Advanced Cardiovascular Systems, Inc. | 1997-08-12 |
| SCIMED(R) RANGER(TM) PERCUTANEOUS CORONARY ANGIOPLASTY (PTCA) CATHETER (P860019/S125) | Scimed Life Systems, Inc. | 1997-08-12 |
| MEDTRONIC(R)MILLENIA TM 15 CORONARY BALLOON DILATATION CATHETER (P870036/S043) | Medtronics Interventional Vascular | 1997-08-12 |
| CADENCE(R) TIERED THERAPY DEFIBRILLATOR SYSTEM (P910023/S029) | ABBOTT MEDICAL | 1997-08-12 |
| SCIMED(R) RANGER(TM) PERCUTANEOUS CORONARY ANGIOPLASTY (PTCA) CATHETER (P860019/S126) | Scimed Life Systems, Inc. | 1997-08-12 |
| VIGOR(R) DR/SR PACEMAKER SYSTEM (P940031/S010) | Boston Scientific | 1997-08-08 |
| VENTAK AV AICD TM SYSTEM (P960040/S001) | Boston Scientific | 1997-08-08 |
| TITAN MEGA AND TITAN MEGA XL PTCA DILATATION CATHETERS (P880003/S067) | Cordis Corp. | 1997-08-08 |
| VENTAK PRX AICD SYSTEM (P910077/S021) | Boston Scientific | 1997-08-08 |
| DELTA(R) PACEMAKER SYSTEM (VIGOR SSI AND DDD MODELS ONLY) (P840068/S033) | Boston Scientific | 1997-08-08 |
| REFLEX MODELS 8218 AND 822OE; REFLEX DDD MODELS 8223E AND 8224; AND SIMPLEX MODEL 8232 PULSE GENERATORS (P820018/S071) | St. Jude Medical, Inc. | 1997-08-07 |
| META DDDR MODEL 1256 PULSE GENERATOR (P900070/S016) | St. Jude Medical, Cardiac Rhythm Management Divisi | 1997-08-07 |
| SCIMED(R) NC REBEL (TM) PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER (P860019/S120) | Scimed Life Systems, Inc. | 1997-08-01 |
| ATAKR RADIOFREQUENCY CATHETER ABLATION (RFCA) SYSTEM (P930029/S008) | Medtronic, Inc. | 1997-07-29 |
| MOMENTUM PACERS (P910020/S019) | Boston Scientific | 1997-07-29 |
| MAESTRO(R) II MODEL 534 PACEMAKER SYSTEM (P860027/S012) | Cardiac Control Systems, Inc. | 1997-07-29 |
| ANGIO-SEAL(TM)[1] HEMOSTATIC PUNCTURE CLOSURE DEVICE (P930038/S006) | Terumo Medical Corporation | 1997-07-28 |
| MEDTRONIC(R) MS2(TM) BALLOON SHAPING TOOL (P870036/S042) | Medtronics Interventional Vascular | 1997-07-28 |
| VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM (P960040) | Boston Scientific | 1997-07-18 |
| MEDTRONIC SPRINT TM MODEL 6942 LEAD (P920015/S012) | Medtronic, Inc. | 1997-07-18 |
| CHARGER PTCA DILATATION CATHETERS (P880003/S069) | Cordis Corp. | 1997-07-18 |
| ACS RX LIFESTREAM (P810046/S176) | Advanced Cardiovascular Systems, Inc. | 1997-07-17 |
| SCIMED NC BIB RANGER PTCA CATHETER (P860019/S123) | Scimed Life Systems, Inc. | 1997-07-15 |
| SCIMED(R) RANGER(TM) PERCUTANEOUS CORONARY ANGIOPLASTY (PTCA) CATHETER (P860019/S124) | Scimed Life Systems, Inc. | 1997-07-15 |
| THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM (P870072/S004) | Thoratec Laboratories Corp. | 1997-07-10 |
| ACS RX LIFESTREAM (P810046/S175) | Advanced Cardiovascular Systems, Inc. | 1997-07-03 |
| GUARDIAN(R) ATP II IMPLANTABLE CARDIOVERTER/DIFIB. (P940024) | Telectronics Pacing Systems, Inc. | 1997-07-03 |
| MEDTRONIC ARRHYTHMIA MANAGEMENT DEVICES INCLUDING MODEL 7221B/CX/D/E MICRO JEWEL DEVICE USED WITH CPI ENDOTAK (P900061/S033) | Medtronic Cardiac Rhythm Disease Management | 1997-07-02 |
| CADENCE(R) TIERED THERAPY DEFIBRILLATOR SYSTEM (P910023/S026) | ABBOTT MEDICAL | 1997-07-01 |
| TRILOGY DR+ PULSE GENERATOR MODELS 2360L AND 2364L PULSE GENERATORS MODELS 2360L AND 2364L (P880086/S037) | ABBOTT MEDICAL | 1997-06-30 |
| APS II 3003 PROGRAMMER WITH MODEL 3203A FUNCTION PACK (P880006/S025) | St. Jude Medical, Inc. | 1997-06-30 |
| AFP PACING SYSTEM (P830045/S053) | St. Jude Medical, Inc. | 1997-06-30 |
| ORACLE MEGASONICS FIVE-64 PTCA CATHETER (P910031/S016) | Abbott Vascular Devices | 1997-06-27 |
| MEDTRONIC WIKTOR PRIME CORONARY STENT DELIVERY SYSTEM (P960010) | Medtronics Interventional Vascular | 1997-06-27 |
| E P TECH EPT-1000 CARDIAC ABLATION SYSTEM (P920047/S007) | Boston Scientific Corp | 1997-06-24 |
| TENDRIL DX MODEL 1388T & 1388K ENDOCARDIAL PACING LEADS (P960013) | ABBOTT MEDICAL | 1997-06-20 |
| WALLSTENT(R) ILIAC ENDOPROSTHESIS (P940019/S003) | Boston Scientific Scimed, Inc. | 1997-06-16 |
| MEDTRONIC ARRHYTHMIA MANAGEMENT DEVICES INCLUDING MODEL 7221B/CX/D/E MICRO JEWEL DEVICE USED WITH CPI ENDOTAK (P900061/S032) | Medtronic Cardiac Rhythm Disease Management | 1997-06-12 |
| LEOCOR SABLE(TM) PTCA CATHETER (P890001/S018) | Leocor, Inc. | 1997-06-11 |
| ACS TX2000 VP CORONARY DILITATION CATHETER (P810046/S174) | Advanced Cardiovascular Systems, Inc. | 1997-06-11 |
| SCIMED(R) RANGER(TM) PERCUTANEOUS CORONARY ANGIOPLASTY (PTCA) CATHETER (P860019/S116) | Scimed Life Systems, Inc. | 1997-06-11 |
| LEOCOR PICO-ST (P890001/S019) | Leocor, Inc. | 1997-06-09 |
| SCIMED(R) RANGER(TM) PERCUTANEOUS CORONARY ANGIOPLASTY (PTCA) CATHETER (P860019/S119) | Scimed Life Systems, Inc. | 1997-06-09 |
| SCIMED(R) RANGER(TM) PERCUTANEOUS CORONARY ANGIOPLASTY (PTCA) CATHETER (P860019/S122) | Scimed Life Systems, Inc. | 1997-06-05 |
| ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM (P900023/S022) | Abiomed Cardiovascular, Inc. | 1997-06-04 |
| THE WRAP(PTCA) CATHETER (P930012/S006) | Progressive Angioplasty Systems, Inc. | 1997-05-29 |
| CADENCE(R) TIERED THERAPY DEFIBRILLATOR SYSTEM (P910023/S028) | ABBOTT MEDICAL | 1997-05-29 |
| CARBOMEDICS PROSTHETIC HEART VALVE (CPHV) (P900060/S014) | Corcym S.r.l. | 1997-05-27 |
| TCI HEARTMATE(R) 1000A IP LVAS (P920014/S006) | Thoratec Corp | 1997-05-22 |
| CADENCE(R) TIERED THERAPY DEFIBRILLATOR SYSTEM (P910023/S024) | ABBOTT MEDICAL | 1997-05-22 |
| ROTABLATOR(R) ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK(TM) (P900056/S020) | Boston Scientific Corp | 1997-05-13 |
| ACS CORONARY DILATATION CATHETERS (INDICATION) (P810046/S170) | Advanced Cardiovascular Systems, Inc. | 1997-05-13 |
| GIANTURCO-ROUBIN CORONARY FLEX-STENT(TM) 12MM LONG (P910030/S005) | Cook, Inc. | 1997-05-12 |
| ACS RX COMET CORONARY DILATION CATHETER (P810046/S171) | Advanced Cardiovascular Systems, Inc. | 1997-05-12 |
| VENTAK PRX AICD,SYSTEM FOR THE RHYTHMLINE TM TRANSTELPHONIC INTERROGATION SYSTEM MINI HC AICD, VENTAK II AICD (P910077/S018) | Boston Scientific | 1997-05-06 |
| ANGIO-SEAL(TM)[1] HEMOSTATIC PUNCTURE CLOSURE DEVICE (P930038/S005) | Terumo Medical Corporation | 1997-05-01 |
| THOR PTCA DILATATION CATHETERS WITH 10 MM AND 40 MM LONG BALLOONS (P880003/S066) | Cordis Corp. | 1997-04-30 |
| PTCA DILATATION CATHETERS FOR VALOR AND VALOR XL PTCA (P880003/S065) | Cordis Corp. | 1997-04-30 |
| PROSTAR 9 FR. PERCUTANEOUS VASCULAR SURGICAL (PVS) SYSTEM (P960043) | Abbott Vascular, Inc. | 1997-04-30 |
| MODEL 9602 PROGRAMMER (P880038/S034) | St. Jude Medical, Inc. | 1997-04-29 |
| MODEL 1256D META MV CARDIAC PULSE GENERATOR (P900070/S019) | St. Jude Medical, Cardiac Rhythm Management Divisi | 1997-04-29 |
| MODEL 9602 PROGRAMMER (P820018/S072) | St. Jude Medical, Inc. | 1997-04-29 |
| MODEL 1256D META MV CARDIAC PULSE GENERATOR (P900070/S018) | St. Jude Medical, Cardiac Rhythm Management Divisi | 1997-04-29 |
| RX5000 (TM) GRAPHICS PROGRAMMER (P830026/S069) | Boston Scientific | 1997-04-28 |
| ANGIO-SEAL(TM)[1] HEMOSTATIC PUNCTURE CLOSURE DEVICE (P930038/S004) | Terumo Medical Corporation | 1997-04-25 |
| ANGIO-SEAL(TM)[1] HEMOSTATIC PUNCTURE CLOSURE DEVICE (P930038/S002) | Terumo Medical Corporation | 1997-04-25 |