| MODEL 1256D META MV CARDIAC PULSE GENERATOR (P900070/S020) | St. Jude Medical, Cardiac Rhythm Management Divisi | 1997-10-07 |
| PROSTATRON (P950014/S010) | Urologix, Inc. | 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 |
| MODEL PC-28LB POSTERIOR CHAMBER INTRAOCULAR LENS (P890056/S005) | Advanced Medical Optics, Inc. | 1997-10-02 |
| MODELS PC-58NBM & PC-58NBZ IOLS (P820049/S064) | Advanced Medical Optics, Inc. | 1997-10-02 |
| MODES SI-18B AND SI-18NB ULTRAVIOLET ABSORBINGSILICONE POSTERIOR CHAMBER IOLS (P880081/S023) | Johnson & Johnson Surgical Vision, Inc. | 1997-10-02 |
| MODELS AC-21/AC-21B ANTERIOR CHAMBER IOL (P860034/S015) | Advanced Medical Optics, Inc. | 1997-10-02 |
| SOFLENS66(TM) (P960022/S001) | Bausch & Lomb, Inc. | 1997-09-30 |
| MONOSTRUT CARDIAC VALVE PROSTHESIS (P970002) | Alliance Medical Technologies, Inc. | 1997-09-30 |
| VITREON(R) (P910068) | Air Products & Chemicals, Inc. | 1997-09-30 |
| PERIOGARD PERIODONTAL TISSUE MONITOR (P960031/S001) | Xytronyx, 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 |
| MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL (P970004) | Medtronic Neuromodulation | 1997-09-29 |
| MEDSTONE STS(TM) LITHOTRIPTER (P870015/S026) | Medstone Intl., Inc. | 1997-09-29 |
| ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM (P900023/S024) | Abiomed Cardiovascular, Inc. | 1997-09-26 |
| NIC 1800 NEEDLE DISPOSAL SYSTEM (P970036) | Nic , Ltd. | 1997-09-26 |
| SILIKON 1000 (P950008) | Alcon | 1997-09-25 |
| PROSTATRON (P950014/S009) | Urologix, Inc. | 1997-09-24 |
| VITESSE TM -E (ECCENTRIC MONORAIL) CATHETER MODEL 120-008 (P910001/S012) | Spectranetics Corp. | 1997-09-24 |
| CONSTANT FLOW IMPLANTABLE PUMP WITH BOLUS SAFETY VALVE (P890055/S003) | Intera Oncology | 1997-09-22 |
| H.E.L.P. SYSTEM (P940016) | B. Braun Avitum AG | 1997-09-19 |
| ACS RX ESPRIT (P810046/S177) | Advanced Cardiovascular Systems, Inc. | 1997-09-19 |
| SPINAL-STIM LITE SPINAL FUSION SYSTEM (P850007/S019) | Orthofix, 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 |
| MEDTRONIC SYNCHROMED INFUSION SYSTEM (P860004/S038) | Medtronic, Inc. | 1997-09-18 |
| HYPERTHERMIA SYSTEM 100 A (P880064/S002) | Medifocus, Inc. | 1997-09-17 |
| 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 |
| GENESA(R) SYSTEM (P940001) | Gensia, Inc. | 1997-09-12 |
| 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 |
| SEPRAFILM BIORESORBABLE MEMBRANE (P950034/S007) | Baxter Healthcare Corporation | 1997-09-11 |
| PRO OSTEON IMPLANT 500 CORALLINE HYDROXYPATITE BONE VOID FILLER (FORMERLY INTERPORE 500) (P860005/S008) | Interpore Intl. | 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 |
| OSTEOBOND(TM) COPOLYMER BONE CEMENT (N17755/S049) | Zimmer, Inc. | 1997-09-05 |
| CLARION MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC) S-SERIES TM SPEECH PROCESSOR (P960058/S001) | Advanced Bionics | 1997-09-05 |
| AMO ARRAY MULTIFOCAL UV-ABSORBING SILCONE POSTERIOR CHAMBER INTRAOCULAR LENS (P960028) | Johnson & Johnson Surgical Vision, Inc. | 1997-09-05 |
| CLARION(TM) MULTI-STRATEGY COCHLEAR IMPLANT (ADULT) S-SERIES TM SPEECH PROCESSOR (P940022/S003) | Advanced Bionics Corp. | 1997-09-05 |
| 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 |
| UROLOGIX TARGIS SYSTEM (P970008/S001) | Urologix, LLC | 1997-08-28 |
| 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 |
| IMX TACROLIMUS II ASSAY (P970007) | Abbott Laboratories | 1997-08-26 |
| MENICON SF-P (MELAFOCON A) CONTACT LENS (P880098/S010) | Menicon Co, Ltd. | 1997-08-25 |
| FLUOROPERM 92,60,30(PAFLUFOCON A,B,C )RGP LENSES (P870024/S041) | CooperVision, Inc. | 1997-08-25 |
| TARGIS (T3) SYSTEM (P970008) | Urologix, LLC | 1997-08-22 |
| NEUROCYBERNETIC PROTHESIS SYSTEM (P970003/S001) | LivaNova USA, Inc. | 1997-08-21 |
| NEUROCONTROL FREEHAND SYSTEM(R) (P950035) | Biocontrol Technology, Inc. | 1997-08-15 |
| HYBRID CAPTURE(TM) SYSTEM HPV DNA ASSAY (P890064/S005) | Qiagen Gaithersburg, Inc. | 1997-08-15 |
| DR. BROWN'S HOME DRUG TESTING KIT (P950040/S003) | Personal Health & Hygiene, Inc. | 1997-08-15 |
| 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 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S009) | Howmedica Corp. | 1997-08-08 |
| VENTAK AV AICD TM SYSTEM (P960040/S001) | Boston Scientific | 1997-08-08 |
| SYNVISC ONE (P940015) | Sanofi Genzyme Corp. | 1997-08-08 |
| TITAN MEGA AND TITAN MEGA XL PTCA DILATATION CATHETERS (P880003/S067) | Cordis Corp. | 1997-08-08 |
| DUPEN LONG TERM EPIDURAL CATHETER (P860064/S008) | C.R. Bard, Inc. | 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 |
| ABBOTT IMX PSA (P910007/S004) | Abbott Laboratories | 1997-08-07 |
| INTEGRA (ARTIFICIAL SKIN) (P900033/S002) | Integra Lifesciences Corp. | 1997-08-07 |
| 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 |
| MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM (P960009) | Medtronic, Inc. | 1997-07-31 |
| 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 |
| ABBOTT IMX(R) HAVAB(R)-M (P790019/S010) | Abbott Laboratories | 1997-07-24 |
| BAK INTERBODY FUSION SYSTEM (P950002/S001) | Zimmer Spine, Inc. | 1997-07-22 |
| HEALTHTRONICS LITHOTRON LIHTOTRIPSY SYSTEM (P970019) | Healthtronics Surgical Services, Inc. | 1997-07-21 |
| 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 |
| OSTEOGEN IMPLANTABLE SPINAL FUSION STIMULATOR (P790005/S039) | Ahp Eos Buyer, Inc. | 1997-07-17 |
| MEDTRONIC SYNCHROMED INFUSION SYSTEM (P860004/S036) | Medtronic, Inc. | 1997-07-17 |
| EBI SPF IMPLANTABLE SPINAL FUSION STIMULATOR MODEL SPF-XL II (P850035/S021) | Ahp Eos Buyer, Inc. | 1997-07-17 |
| VNS THERAPY SYSTEM (P970003) | LivaNova USA, Inc. | 1997-07-16 |
| 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 |
| ACUVUE(R) (ETAFILCON A) EXTENDED WEAR CONTACT LENS (CLEAR AND TINTED WITH UV BLOCKER) (N18033/S031) | Vistakon, Johnson & Johnson Vision Products, Inc. | 1997-07-11 |
| CONTIGEN BARD COLLAGEN IMPLANT (P900030/S006) | Allergan, Inc. | 1997-07-11 |
| THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM (P870072/S004) | Thoratec Laboratories Corp. | 1997-07-10 |