| ONCOR(R) AMPLITECT(TM) HER/NEU(ERBB2)GENE AMPLIFI (P940004) | Ventana Medical Systems, Inc. | 1997-12-30 |
| HYSKON (32% DEXTRAN 70) (N17511/S012) | Coopervision Surgical | 1997-12-30 |
| AMO ARRAY MULTIFOCAL UV-ABSORBING SILCONE POSTERIOR CHAMBER INTRAOCULAR LENS (P960028/S002) | Johnson & Johnson Surgical Vision, Inc. | 1997-12-30 |
| RES-Q(TM) MICRON ICD SYSTEM (P940008/S008) | Boston Scientific | 1997-12-29 |
| LITHOSTAR MULTILINE (P870018/S019) | Siemens Corp. | 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 |
| NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P890027/S039) | Cochlear Americas | 1997-12-28 |
| ADATO SIL 5000 (P910071/S004) | Bausch & Lomb | 1997-12-24 |
| 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 |
| MEMORYLENS ULTRAVIOLET-ABSORBING HYDROPHILIC POSTERIOR CHAMBER INTRAOCULAR LENS (MODEL U940A) (P960036) | Ioltech, S.A. | 1997-12-22 |
| ROTABLATOR(R) ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S021) | Boston Scientific Corp | 1997-12-19 |
| INFUSAID IMPLANTABLE INFUSION PUMP (P800036/S034) | Intera Oncology | 1997-12-19 |
| PALMAZ-SCHATZ(TM) BALLOON EXPANDABLE STENT WITH DELIVERY SYSTEM (P900043/S007) | Cordis Corp. | 1997-12-19 |
| INFUSAID IMPLANTABLE INFUSION PUMP (P800036/S035) | Intera Oncology | 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 |
| THERMACHOICE UTERINE BALLOON THERAPY(UBT) SYSTEM (P970021) | Gynecare, Inc. | 1997-12-12 |
| 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 |
| VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD (N50510/S079) | Biomerieux Vitek, Inc. | 1997-12-08 |
| VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD (N50510/S078) | Biomerieux Vitek, 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 |
| UROLOGIC TARGIS SYSTEM (P970008/S004) | Urologix, LLC | 1997-11-26 |
| 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 |
| KONTRON CUTANEOUS PCO2 MONITOR (P810037/S007) | Kontron Cardiovascular | 1997-11-25 |
| DERMAGRAFT-TC(TM) (P960007/S003) | Shire Regenerative Medicine | 1997-11-24 |
| PROSTATRON (P950014/S006) | Urologix, Inc. | 1997-11-24 |
| 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 |
| NEUROCYBERNETIC PROTHESIS SYSTEM (P970003/S003) | LivaNova USA, Inc. | 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 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S010) | Howmedica Corp. | 1997-11-13 |
| ENDURANCE BONE CEMENT (P960001/S001) | Depuy, Inc. | 1997-11-12 |
| TAKUMI OVER THE WIRE PTCA CATHETERS (P880027/S049) | Boston Scientific | 1997-11-10 |
| HEALTHTRONICS LITHOTRON LIHTOTRIPSY SYSTEM (P970019/S001) | Healthtronics Surgical Services, Inc. | 1997-11-10 |
| GUARDIAN CORONARY BALLOON DILATATION PTCA CATHETER (P910031/S017) | Abbott Vascular Devices | 1997-11-10 |
| PROSTATRON (P950014/S008) | Urologix, Inc. | 1997-11-07 |
| ACS RX ROCKET TM AND ACS AVENGER CORONARY DILATATION CAHTETERS (P810046/S179) | Advanced Cardiovascular Systems, Inc. | 1997-11-07 |
| SONOLITH 3000 LITHOTRIPTER (P880011/S009) | Edap International Corp. | 1997-11-06 |
| 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 |
| BIOCURVE SOFT EW (METHAFILCON A) HYDROPHILIC CONTACT LENSES (P860040/S014) | Wavetouch Technologies, LLC | 1997-11-04 |
| TORONTO SPV VALVE (P970030) | St. Jude Medical, Inc. | 1997-11-04 |
| DORNIER LITHOTRIPTER (STATIONARY AND MOBILE) (P840008/S061) | Dornier Medtech America, Inc. | 1997-11-03 |
| MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION SYSTEM (P970004/S001) | Medtronic Neuromodulation | 1997-10-31 |
| STORZ TRANSPORTABLE MODULITH SLX LITHOTRIPTER VERSION) ANSPORTABLE VERSION) (P920051/S007) | KARL STORZ Endoscopy-America, Inc. | 1997-10-31 |
| 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 |
| MEDSTONE STS(TM) LITHOTRIPTER (P870015/S027) | Medstone Intl., Inc. | 1997-10-31 |
| GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST) (P940034/S006) | Gen-Probe, Inc. | 1997-10-30 |
| ABBOTT AXSYM AFP (P820060/S012) | Abbott Laboratories | 1997-10-29 |
| OSTEOBOND(TM) COPOLYMER BONE CEMENT (N17755/S048) | Zimmer, Inc. | 1997-10-28 |
| UROLOGIC TARGIS SYSTEM (P970008/S003) | Urologix, LLC | 1997-10-28 |
| PROSTATRON (P950014/S007) | Urologix, Inc. | 1997-10-27 |
| 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 |
| MODEL 809A POSTERIOR CHAMBER INTRAOCULAR LENS (P810055/S068) | Advanced Medical Optics, Inc. | 1997-10-22 |
| MODEL LI51U & LI61U SOFLEX UV-ABSORBING SILICONE PC IOL (P910061/S001) | Bausch & Lomb | 1997-10-21 |
| ST. JUDE MEDICAL MECHANICAL HEART VALVE (P810002/S044) | ABBOTT MEDICAL | 1997-10-20 |
| DERMAGRAFT-TC(TM) (P960007/S001) | Shire Regenerative Medicine | 1997-10-17 |
| TEMPO PULSE GENERATORS (P900070/S021) | St. Jude Medical, Cardiac Rhythm Management Divisi | 1997-10-16 |
| NATURAL-KNEE(R) WITH CSTI(TM) (P940002/S002) | Sulzermedica | 1997-10-16 |
| SEREINE WETTING & SOAKING SOLU. (NEW PRESERVATIVE) (P870051/S007) | Trp Company | 1997-10-15 |
| BAK INTERBODY FUSION SYSTEM (P950002/S003) | Zimmer Spine, Inc. | 1997-10-15 |
| IPAFLUOROFOCON A AND B (P860022/S048) | Bausch & Lomb | 1997-10-15 |
| SEREINE CONTACT LENS CLEANER (NEW PRESERVATIVE) (P870050/S007) | Trp Company | 1997-10-15 |
| SOFLENS (POLYMACON) CONTACT LENSES (N16895/S085) | Bausch & Lomb, Inc. | 1997-10-15 |
| BONNIE (TM) PTCA CATHERS (P880027/S048) | Boston Scientific | 1997-10-09 |
| NEUROCYBERNETIC PROTHESIS SYSTEM (P970003/S002) | LivaNova USA, Inc. | 1997-10-09 |
| NEUROCYBERNETIC PROTHESIS SYSTEM (P970003/S005) | LivaNova USA, Inc. | 1997-10-09 |
| THINPREP 2000 SYSTEM (P950039/S004) | Hologic, Inc. | 1997-10-08 |
| APS III MODEL 3500 PROGRAMMER (P830045/S054) | St. Jude Medical, Inc. | 1997-10-07 |
| MODEL PC-28LB POSTERIOR CHAMBER INTRAOCULAR LENS (P890056/S003) | Advanced Medical Optics, Inc. | 1997-10-07 |
| MODELS AC-21/AC-21B ANTERIOR CHAMBER IOL (P860034/S013) | Advanced Medical Optics, Inc. | 1997-10-07 |
| 5ODEL SI-11NB UV ABSORBING SILICONE POSTERIOR IOL (P880081/S019) | Johnson & Johnson Surgical Vision, Inc. | 1997-10-07 |
| MODELS PC-58NBM & PC-58NBZ IOLS (P820049/S062) | Advanced Medical Optics, Inc. | 1997-10-07 |
| AMO ARRAY MULTIFOCAL UV-ABSORBING SILCONE POSTERIOR CHAMBER INTRAOCULAR LENS (P960028/S001) | Johnson & Johnson Surgical Vision, Inc. | 1997-10-07 |
| APS III MODEL 3500 PROGRAMMER (P880086/S041) | ABBOTT MEDICAL | 1997-10-07 |