| MERIDIAN AND DISCOVERY PACEMAKER SYSTEMS (P940031/S013) | Boston Scientific | 1998-05-28 |
| ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM (P900023/S027) | Abiomed Cardiovascular, Inc. | 1998-05-28 |
| MEDTRONIC WIKTOR RIVAL CORONARY STENT SYSTEM (P960010/S001) | Medtronics Interventional Vascular | 1998-05-21 |
| COSMO, STRIDE, DASH, DART, UNITY, NOVA, QUANTUM PULSE GENERATORS (P830026/S071) | Boston Scientific | 1998-05-21 |
| MODEL 9790C PROGRAMMER AND MODEL 9891 PE SOFTWARE (P890003/S056) | Medtronic, Inc. | 1998-05-21 |
| MEDTRONIC . KAPPA 400 SERIES PULSE GENERATORS (P970012/S001) | Medtronic, Inc. | 1998-05-21 |
| COSMOS, STRIDE, DASH, DART, UNITY, NOVA, QUANTUM PULSE GENERATORS (P910020/S021) | Boston Scientific | 1998-05-21 |
| THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM (P870072/S005) | Thoratec Laboratories Corp. | 1998-05-21 |
| GUARDIAN CORONARY BALLOON DILATATION PTCA CATHETER (P970052/S002) | Endologix, Inc. | 1998-05-19 |
| USCI APOLLO RELY ADDITIONAL SIZES (P790017/S066) | Medtronic, Ireland | 1998-05-18 |
| ACS RX ROCKET ACS AVENGER CORONARY DILATATION CATHETER (P810046/S183) | Advanced Cardiovascular Systems, Inc. | 1998-05-14 |
| SCIMED QUANTUM RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER (P860019/S142) | Scimed Life Systems, Inc. | 1998-05-13 |
| APS II 3003 PROGRAMMER WITH MODEL 3203A FUNCTION PACK (P880006/S026) | St. Jude Medical, Inc. | 1998-05-07 |
| WEBSTER DIAG./ABLATION DEFLECTABLE TIP CATHETER (P950005/S001) | Biosense Webster, Inc. | 1998-05-07 |
| STAT-PACE II ESOPHAGEAL PACING SYSTEM (P840002/S008) | Cardiocommand, Inc. | 1998-05-07 |
| GIANTURCO-ROUBIN CORONARY FLEX-STENT(TM) 12MM LONG (P910030/S008) | Cook, Inc. | 1998-05-05 |
| ORACLE MEGASONICS FIVE-64 PTCA CATHETER (P910031/S015) | Abbott Vascular Devices | 1998-05-01 |
| MERIDIAN AND DISCOVERY PACEMAKER SYSTEMS (P940031/S011) | Boston Scientific | 1998-04-30 |
| ATAKR RADIOFREQUENCY CATHETER ABLATION (RFCA) SYSTEM (P930029/S011) | Medtronic, Inc. | 1998-04-20 |
| SCIMED REBEL PTCA CATHETER (P860019/S137) | Scimed Life Systems, Inc. | 1998-04-15 |
| LYNX CONTOUR CORONARY BALLOON DILATATION CATHETER(A NEW MODEL OF THE FACT CATHETER). (P970052/S001) | Endologix, Inc. | 1998-04-08 |
| SELUTE PICOTIP STEROID ELUTING LEAD (P950001/S003) | Boston Scientific | 1998-04-08 |
| SCIMED REBEL PTCA CATHETER (P860019/S138) | Scimed Life Systems, Inc. | 1998-04-06 |
| PERCLOSE PROSTAR XL 10 FRENCH PVS SYSTEM (P960043/S006) | Abbott Vascular, Inc. | 1998-04-06 |
| E P TECH EPT-1000 CARDIAC ABLATION SYSTEM (P920047/S009) | Boston Scientific Corp | 1998-04-06 |
| DELTA(R) PACEMAKER SYSTEM (VIGOR SSI AND DDD MODELS ONLY) (P840068/S034) | Boston Scientific | 1998-03-27 |
| MERIDIAN AND DISCOVERY PACEMAKER SYSTEMS (P940031/S012) | Boston Scientific | 1998-03-27 |
| ST. JUDE MEDICAL MECHANICAL HEART VALVE SJM MASTERS SERIES WITH SILZONE (P810002/S046) | ABBOTT MEDICAL | 1998-03-24 |
| USCI APOLLO RELY SP OVER-THE-WIRE BALLOON DILATATION CATHETER WITH HYDRO/PEL COATING AND MINIQUET DEVICE (P790017/S065) | Medtronic, Ireland | 1998-03-23 |
| MONOSTRUT CARDIAC VALVE PROSTHESIS (P970002/S001) | Alliance Medical Technologies, Inc. | 1998-03-23 |
| TENDRIL DX MODEL 1388T & 1388K ENDOCARDIAL PACING LEADS (P960013/S001) | ABBOTT MEDICAL | 1998-03-19 |
| RES-Q(TM) MICRON ICD SYSTEM (P940008/S009) | Boston Scientific | 1998-03-17 |
| ACS SWAP-IT GUIDE WIRE EXCHANGE DEVICE CATHETER (P810046/S186) | Advanced Cardiovascular Systems, Inc. | 1998-03-13 |
| VENTAK AV II DR AICD (P960040/S003) | Boston Scientific | 1998-03-13 |
| ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM (P900023/S025) | Abiomed Cardiovascular, Inc. | 1998-03-13 |
| DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS (P950037/S001) | Biotronik, Inc. | 1998-03-13 |
| MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER (P920032/S004) | Pace Medical | 1998-02-27 |
| IVT CORONARY ATHERECTOMY SYSTEM (TEC)(R) (P910019/S005) | Intensive Technology, Inc. | 1998-02-23 |
| CHAMPION WRAP PTCA CATHETER (P930012/S009) | Progressive Angioplasty Systems, Inc. | 1998-02-23 |
| MICRO STENT TM II, MICRO STENT TM II XL, GFX TM, GFX TM XL (P970035/S002) | Medtronic, Ireland | 1998-02-23 |
| ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM CONTRACT STERILIZER (P900056/S023) | Boston Scientific Corp | 1998-02-23 |
| FACT, ARC, LYNX AND GUARDIAN BALLOON CORONARY DILATATION CATHETERS (P970052) | Endologix, Inc. | 1998-02-20 |
| TELESCOPE PTCA BALLOON CATHETER (P790017/S064) | Medtronic, Ireland | 1998-02-12 |
| ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM (P900023/S026) | Abiomed Cardiovascular, Inc. | 1998-02-02 |
| CADENCE(R) TIERED THERAPY DEFIBRILLATOR SYSTEM (P910023/S030) | ABBOTT MEDICAL | 1998-02-02 |
| CHAMPION WRAP PTCA CATHETER (P930012/S008) | Progressive Angioplasty Systems, Inc. | 1998-02-02 |
| VENTAK AV DDD FAMILY OF AICD SYSTEMS (P960040/S005) | Boston Scientific | 1998-02-02 |
| CADENCE(R) TIERED THERAPY DEFIBRILLATOR SYSTEM (P910023/S032) | ABBOTT MEDICAL | 1998-02-02 |
| ANGIO-SEAL(TM)[1] HEMOSTATIC PUNCTURE CLOSURE DEVICE (P930038/S007) | Terumo Medical Corporation | 1998-02-02 |
| MEDTRONIC.KAPPA 400 SERIES PACEMAKERS (P970012) | Medtronic, Inc. | 1998-01-30 |
| MOMENTUM PACERS (P910020/S020) | Boston Scientific | 1998-01-30 |
| IVT CORONARY ATHERECTOMY SYSTEM (TEC)(R) (P910019/S003) | Intensive Technology, Inc. | 1998-01-29 |
| PASSIVE PLUS DX ENDOCARDIAL STEROID ELUTING, PASSIVE-FIXATION PACING LEADS (P960030) | ABBOTT MEDICAL | 1998-01-29 |
| MODEL 9802 E REVEAL INSERTABLE LOOP RECORDER SOFTWARE (P890003/S052) | Medtronic, Inc. | 1998-01-29 |
| ACS TX 2000 VP CORONARY DILATATION CATHETER CAHTETERS (P810046/S182) | Advanced Cardiovascular Systems, Inc. | 1998-01-27 |
| VENTAK MINI HE AND VENTAK MINI III AICD TM SYSTEMS (P910077/S022) | Boston Scientific | 1998-01-23 |
| THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM (P870072/S006) | Thoratec Laboratories Corp. | 1998-01-21 |
| RES-Q(TM) MICRON ICD SYSTEM (P940008/S008) | Boston Scientific | 1997-12-29 |
| TRILOGY DC+ MODEL 2318L PULSE GENERATOR (P880086/S043) | ABBOTT MEDICAL | 1997-12-29 |
| APS III MODEL 3500 PROGRAMMER (P830045/S055) | St. Jude Medical, Inc. | 1997-12-29 |
| PROSTAR TM 8FR AND 10FR PVS AND PROSTAR XL (P960043/S002) | Abbott Vascular, Inc. | 1997-12-29 |
| BONNIE TM SLIDING RAIL PTCA CATHETERS (P880027/S054) | Boston Scientific | 1997-12-23 |
| ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE (P930038/S011) | Terumo Medical Corporation | 1997-12-23 |
| AVE MICRO STENT II OVER-THE-WIRE CORONARY STENT SYSTEM AND AVE GFX OVER-THE-WIRE CORONARY STENT SYSTEM (P970035) | Medtronic, Ireland | 1997-12-23 |
| SCIMED JAZ RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER (P860019/S135) | Scimed Life Systems, Inc. | 1997-12-22 |
| ROTABLATOR(R) ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S021) | Boston Scientific Corp | 1997-12-19 |
| PALMAZ-SCHATZ(TM) BALLOON EXPANDABLE STENT WITH DELIVERY SYSTEM (P900043/S007) | Cordis Corp. | 1997-12-19 |
| E P TECH EPT-1000 CARDIAC ABLATION SYSTEM (P920047/S008) | Boston Scientific Corp | 1997-12-18 |
| ATAKR RADIOFREQUENCY CATHETER ABLATION (RFCA) SYSTEM (P930029/S010) | Medtronic, Inc. | 1997-12-18 |
| VENTAK P2 AICD MODEL 1625 & VENTAK P3 AICD MODELS 1630 AND 1635 (P930035/S008) | Boston Scientific | 1997-12-15 |
| USCI(R)TELESCOPE(TM) SINGLE OPERATOR BALLOON (P790017/S060) | Medtronic, Ireland | 1997-12-15 |
| VENTAK AV AICD TM SYSTEM (P960040/S002) | Boston Scientific | 1997-12-09 |
| SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM & LASER SHEATH (P960042) | Spectranetics (Philips) | 1997-12-09 |
| SCIMED JAZ RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER (P860019/S134) | Scimed Life Systems, Inc. | 1997-12-08 |
| SCIMED JAZ RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER (P860019/S132) | Scimed Life Systems, Inc. | 1997-12-08 |
| VENTAK AV DDD FAMILY OF AICD SYSTEMS (P960040/S004) | Boston Scientific | 1997-12-04 |
| USCI APOLLO RELY OVER-THE-WIRE BALLON DILATATION CATHETER WITH HYDRO/PEL COATING AND MINIQUET DEVICE (P790017/S062) | Medtronic, Ireland | 1997-12-01 |
| ACS TX 2000 VP CORONARY DILATATION CATHETER CAHTETERS (P810046/S181) | Advanced Cardiovascular Systems, Inc. | 1997-11-26 |
| MEDTRONIC ARRHYTHMIA MANAGEMENT DEVICES INCLUDING MODEL 7221B/CX/D/E MICRO JEWEL DEVICE USED WITH CPI ENDOTAK (P900061/S034) | Medtronic Cardiac Rhythm Disease Management | 1997-11-26 |
| MEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESIS (P970031) | Medtronic, Inc. | 1997-11-26 |
| MEDTRONIC(R) HALL PROSTHETIC HEART VALVE (P790018/S031) | Medtronic Cardiac Surgery | 1997-11-24 |
| SEQUEL CONVERTIBLE RAPID EXCHANGE PTCA CATHETER (P840040/S051) | Boston Scientific Corp | 1997-11-21 |
| RES-Q(TM) MICRON ICD SYSTEM (P940008/S007) | Boston Scientific | 1997-11-21 |
| BONNIE SLIDING RAIL PTCA CATHETERS (P880027/S053) | Boston Scientific | 1997-11-21 |
| CAPSURE(R) AND CAPSURE(R) SP SILICONE PACING LEADS (P850089/S037) | Medtronic Cardiac Rhythm Disease Management | 1997-11-21 |
| EDGEBAND PACER RELAY MODEL 294-03E (P910020/S018) | Boston Scientific | 1997-11-18 |
| PREVAIL PACEMAKERS (P850051/S054) | Medtronic, Inc. | 1997-11-18 |
| PROSTAR TM 8FR AND 10FR PVS AND PROSTAR XL (P960043/S003) | Abbott Vascular, Inc. | 1997-11-18 |
| TITAN MEGA AND TITAN MEGA XL PTCA DILATATION CATHETERS (P880003/S068) | Cordis Corp. | 1997-11-18 |
| PREVA, PRODIGY, VITATRON AND THERA PACEMAKERS (P890003/S051) | Medtronic, Inc. | 1997-11-18 |
| ENDOTAK C LEAD, SQ PATCH LEAD, SQ LEAD ARRAY, DSP LEAD (P910073/S023) | Boston Scientific | 1997-11-17 |
| ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE (P930038/S009) | Terumo Medical Corporation | 1997-11-17 |
| TAKUMI OVER THE WIRE PTCA CATHETERS (P880027/S049) | Boston Scientific | 1997-11-10 |
| GUARDIAN CORONARY BALLOON DILATATION PTCA CATHETER (P910031/S017) | Abbott Vascular Devices | 1997-11-10 |
| ACS RX ROCKET TM AND ACS AVENGER CORONARY DILATATION CAHTETERS (P810046/S179) | Advanced Cardiovascular Systems, Inc. | 1997-11-07 |
| TECHSTAR (TM) 6 FRENCH PERCUTANEOUS VASCULAR SURGICAL (PVS) SYSTEM (P960043/S001) | Abbott Vascular, Inc. | 1997-11-05 |
| CADENCE(R) TIERED THERAPY DEFIBRILLATOR SYSTEM (P910023/S031) | ABBOTT MEDICAL | 1997-11-05 |
| TORONTO SPV VALVE (P970030) | St. Jude Medical, Inc. | 1997-11-04 |
| SCIMED(R) RANGER(TM) PERCUTANEOUS CORONARY ANGIOPLASTY (PTCA) CATHETER (P860019/S130) | Scimed Life Systems, Inc. | 1997-10-31 |
| SCIMED BANDIT AND RANGER PTCA CATHETERS (P860019/S133) | Scimed Life Systems, Inc. | 1997-10-31 |