| ROTABLATOR(R) ROTALINK EXCHANGEABLE CATHETER (P900056/S059) | Boston Scientific Corp | 2000-12-29 |
| FEMSOFT URETHRAL INSERT (P990002/S001) | Rochester Medical Corp. | 2000-12-28 |
| ANCURE ENDOGRAFT SYSTEM (P990017/S013) | Boston Scientific Corp | 2000-12-28 |
| NIR PREMOUNTED STENT DELIVERY SYSTEMS (P980001/S027) | Boston Scientific Corp | 2000-12-27 |
| TECHNOLAS 217A EXCIMER LASER SYSTEM (P990027/S001) | Technolas Perfect Vision GmbH | 2000-12-22 |
| ACS:180(TM)/ADVIA CENTAUR(TM) PSA ASSAY (P950021/S002) | Siemens Healthcare Diagnostics | 2000-12-22 |
| MENTOR SALINE-FILLED MAMMARY PROSTHESES (P990075/S002) | Mentor Worldwide, LLC | 2000-12-22 |
| MICRONY PACEMAKERS (P970013) | ABBOTT MEDICAL | 2000-12-21 |
| MC GHAN SALINE-FILLED BREAST IMPLANTS (P990074/S002) | Allergan | 2000-12-21 |
| APLIGRAF(R)(GRAFTSKIN) (P950032/S021) | Organogenesis, Inc. | 2000-12-21 |
| Q 103 NEEDLE MANAGEMENT SYSTEM (P980020) | Qcare International, LLC | 2000-12-21 |
| SEPRAFILM(R) BIORESORBABLE MEMBRAND (P950034/S017) | Baxter Healthcare Corporation | 2000-12-20 |
| S670/S660/BESTENT(TM)2 WITH DISCRETE TECHNOLOGY RAPID EXCHANGE CORONARY STENT SYSTEM (P000022/S003) | Medtronic Vascular | 2000-12-19 |
| S670/S660/BESTENT(TM)2/WITH DISCRETE TECHNOLOGY RAPID EXCHANGE CORONARY STENT DELIVERY SYSTEM (P970035/S023) | Medtronic, Ireland | 2000-12-19 |
| NOVOSTE(TM) BETA-CATH(TM) SYSTEM (P000018/S002) | Best Vascular, Inc. | 2000-12-18 |
| SPRINT QUATTRO MODEL 6944 LEAD (P920015/S017) | Medtronic, Inc. | 2000-12-15 |
| SALINE FILLED BREAST IMPLANT (P990074/S003) | Allergan | 2000-12-15 |
| SURGICAL SIMPLEX P BONE CEMENT (N17004/S013) | Howmedica Corp. | 2000-12-15 |
| BESTENT 2 WITH DISCRETE TECHNOLOGY OTW/RAPID EXCHANGE CORONARY STENT DELIVERY SYSTEM (P000022/S001) | Medtronic Vascular | 2000-12-14 |
| ALTO DR ICD (P980049/S003) | MicroPort CRM USA, Inc. | 2000-12-14 |
| INTER FIX RP THREADED FUSION DEVICE-REDUCED PROFILE (P970015/S017) | Sofamor Danek | 2000-12-13 |
| ITREL SPINAL CORD STIMULATION (SCS) SYSTEM (P840001/S049) | Medtronic Neuromodulation | 2000-12-13 |
| NOVOSTE(TM) BETA-CATH(TM) SYSTEM (P000018/S001) | Best Vascular, Inc. | 2000-12-13 |
| DELTA/VISTA (P840068/S040) | Boston Scientific | 2000-12-13 |
| VENTAK AV DDD/AV II DDDD (P960040/S017) | Boston Scientific | 2000-12-13 |
| ACTIVA DEEP BRAIN STIMULATION (DBS) SYSTEM (P960009/S015) | Medtronic, Inc. | 2000-12-13 |
| GEM III VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR(ICD) (P980016/S015) | Medtronic Cardiac Rhythm Disease Management | 2000-12-12 |
| ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHECK (P000027) | Roche Diagnostics Corp. | 2000-12-12 |
| INTEGRITY U DR MODEL 5336 AND SR MODEL 5136 PULSE GENERATORS (P880086/S081) | ABBOTT MEDICAL | 2000-12-12 |
| INTEGRITY DR MODEL 5336/INTEGRITY SR MODEL 5136 (P830045/S074) | St. Jude Medical, Inc. | 2000-12-12 |
| ROTABLATOR(R) ROTALINK EXCHANGEABLE CATHETER (P900056/S058) | Boston Scientific Corp | 2000-12-12 |
| FLOSEAL MATRIX HEMOSTATIC SEALANT (P990009/S002) | Baxter Healthcare Corp | 2000-12-12 |
| THE CLOSER(TM) AND THE CLOSER S(TM) DEVICES (P960043/S028) | Abbott Vascular, Inc. | 2000-12-12 |
| GEM II MODEL 7273/GEM DR 7271/GEM II VR 7229 ICDS (P980016/S008) | Medtronic Cardiac Rhythm Disease Management | 2000-12-11 |
| GEM MODEL 7227/MICROJEWEL MODELS 7221, 7223 ICDS (P900061/S039) | Medtronic Cardiac Rhythm Disease Management | 2000-12-11 |
| HYPERION LTK SYSTEM (P990078/S001) | Sunrise Technologies, Inc. | 2000-12-11 |
| ECLIPSE TMR HOLMIUM LASER SYSTEM (P970029/S005) | Cryolife, Inc. | 2000-12-08 |
| MAXXUM AND NC MAXXUM PTCA CATHETER (P860019/S166) | Scimed Life Systems, Inc. | 2000-12-08 |
| TENDRILL PASSIVE PLUS/AU PLUS DX (P960030/S008) | ABBOTT MEDICAL | 2000-12-07 |
| HELICOTE ABSORBABLE COLLAGEN WOUND DRESSINGS FOR DENTAL SURGERY (P840062/S007) | Integra Lifesciences Corp. | 2000-12-07 |
| TENDRIL SDX (P960013/S009) | ABBOTT MEDICAL | 2000-12-07 |
| LIPOSORBER LA-15 SYSTEM (P910018/S005) | Kaneka Pharma America Corp. | 2000-12-06 |
| VENTAK MINI IV (AICD) (P910077/S035) | Boston Scientific | 2000-12-06 |
| SALINE-FILLED BREAST IMPLANTS (P990074/S001) | Allergan | 2000-12-06 |
| TETRA(TM) CORONARY STENT SYSTEM (P970020/S026) | Abbott Vascular, Inc. | 2000-12-05 |
| ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S057) | Boston Scientific Corp | 2000-12-05 |
| LIVEWIRE TC(TM) CARDIAC ABLATION SYSTEM:THERMISTOR ONLY TEMPERATURE SENSING (P960016/S005) | St Jude Medical | 2000-12-01 |
| LIVEWIRE TC(TM) CARDIAC ABLATION SYSTEM: 5MM TIP ELECTRODE (P960016/S006) | St Jude Medical | 2000-12-01 |
| ANGIO-SEAL VASCULAR DEVICE - 8F AND 6F (P930038/S026) | Terumo Medical Corporation | 2000-11-29 |
| STINGER ABLATION CATHETER; TEMPLINK EXTENSION CABLE (P000020) | Boston Scientific Corp | 2000-11-29 |
| MEDTRONIC GEMIII DR MODEL 7275 (ICD), MODEL 9970 PROGRAMMER APPLICATION SOFTWARE (P980016/S014) | Medtronic Cardiac Rhythm Disease Management | 2000-11-29 |
| PATHWAY ANTI-HCR-2/NCU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY (P990081) | Ventana Medical Systems, Inc. | 2000-11-28 |
| ACTIVA TREMOR CONTROL SYSTEM (P960009/S014) | Medtronic, Inc. | 2000-11-28 |
| VENTRITEX ICD'S (P910023/S049) | ABBOTT MEDICAL | 2000-11-27 |
| VENTRITEX ICD'S (P830045/S073) | St. Jude Medical, Inc. | 2000-11-27 |
| MEDTRONIC MODEL 4806 ATAKR II RF POWER GENERATOR (P930029/S013) | Medtronic, Inc. | 2000-11-27 |
| VENTRITEX ICD'S (P880086/S080) | ABBOTT MEDICAL | 2000-11-27 |
| UVAR PHOTOPHERESIS SYSTEM (P860003/S036) | Therakos Development Limited | 2000-11-22 |
| HEALON 5 SODIUM HYALURONATE (P810031/S023) | Johnson & Johnson Surgical Vision, Inc. | 2000-11-22 |
| ELECSYS TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSET (P990056) | Roche Diagnostics Corp. | 2000-11-22 |
| GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST) (P940034/S011) | Gen-Probe, Inc. | 2000-11-21 |
| ST. JUDE MEDICAL MECHANICAL HEART VALVE (P810002/S053) | ABBOTT MEDICAL | 2000-11-21 |
| AFFINITY FAMILY OF PULSE GENERATORS (P880086/S079) | ABBOTT MEDICAL | 2000-11-21 |
| CUTTING BALLOON (P950020/S001) | Boston Scientific Corp | 2000-11-21 |
| ANCURE TUBE AND BIFURCATED ENDOGRAFT SYSTEM (P990017/S010) | Boston Scientific Corp | 2000-11-21 |
| THINLINE II/ FINELINE II (P960004/S014) | Boston Scientific | 2000-11-21 |
| ISOMED CONSTANT FLOW INFUSION PUMP (P990034/S001) | Medtronic, Inc. | 2000-11-20 |
| PHACOFLEX II(R) SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS (P880081/S026) | Johnson & Johnson Surgical Vision, Inc. | 2000-11-20 |
| GAMBRO PLASMAFILTER, PF2000N (P830063/S003) | Vantive US Healthcare, LLC | 2000-11-20 |
| CLARION MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC) HIFOCUS ELECTRODE (P960058/S014) | Advanced Bionics | 2000-11-15 |
| SURGIFOAM ABSORBABLE GELATIN HEMORRHOIDECTOMY SPONGE (P990004/S003) | Ferrosan Meidcal Devices A/S | 2000-11-15 |
| THORATEC VENTRICULAR (VAD) ASSIST DEVICE SYSTEM (P870072/S010) | Thoratec Laboratories Corp. | 2000-11-15 |
| THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM (P870072/S011) | Thoratec Laboratories Corp. | 2000-11-15 |
| NEUROCONTROL FREEHAND SYSTEM (P950035/S008) | Biocontrol Technology, Inc. | 2000-11-14 |
| OPTICAL BIOPSY(TM) SYSTEM (P990050) | Spectra Science | 2000-11-14 |
| VITATRON(R) DEMA PACING SYSTEM (P990001/S004) | Medtronic, Inc. | 2000-11-13 |
| ORCHESTRA PROGRAMMER (P980049/S002) | MicroPort CRM USA, Inc. | 2000-11-13 |
| SENOGRAPHE 2000 D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P990066/S001) | GE Healthcare | 2000-11-13 |
| LCS TOTAL KNEE SYSTEM (P830055/S077) | Depuy, Inc. | 2000-11-13 |
| MEDTRONIC HALL PROSTHETIC HEART VALVE (P790018/S036) | Medtronic Cardiac Surgery | 2000-11-09 |
| FRESHLOOK(TM) UV SPHERICAL (PHEMFILCON A) MOLDED SOFT (HYDROPHILIC) CONTACT LENS FOR EXTENDED WEAR (P830037/S043) | Alcon Laboratories, Inc. | 2000-11-09 |
| LCS TOTAL KNEE SYSTEM (P830055/S076) | Depuy, Inc. | 2000-11-08 |
| NIR(TM) PREMOUNTED STENT SYSTEMS (P980001/S026) | Boston Scientific Corp | 2000-11-08 |
| CROSS SAIL CORONARY DILATATION CATHETER (P810046/S202) | Advanced Cardiovascular Systems, Inc. | 2000-11-03 |
| BETA-CATH (TM) SYSTEM (P000018) | Best Vascular, Inc. | 2000-11-03 |
| CORDIS CHECKMATE(TM) SYSTEM (P990036) | Cordis Corp. | 2000-11-03 |
| RELIANCE/RELIANCE S (P910073/S035) | Boston Scientific | 2000-11-02 |
| NUCLEUS 24 CONTOUR COCHLEAR IMPLANT SYSTEM (P970051/S011) | Cochlear Americas | 2000-11-01 |
| DURASPHERE INJECTABLE BULKING AGENT (P980053/S001) | Carbon Medical Technologies, Inc. | 2000-11-01 |
| PHILOS FAMILY OF PULSE GENERATORS (P950037/S016) | Biotronik, Inc. | 2000-10-31 |
| ANGIO-SEAL(TM) EV VASCULAR CLOSURE DEVICE/8 AND 6 FRENCH (P930038/S027) | Terumo Medical Corporation | 2000-10-31 |
| LASERSCAN LSX EXCIMER LASER (P980008/S002) | Lasersight Technologies, Inc. | 2000-10-27 |
| CADENCE TIERED-THERAPY DEFIBRILLATOR SYSTEM (P910023/S047) | ABBOTT MEDICAL | 2000-10-27 |
| EC-5000 EXCIMER LASER SYSTEM (P970053/S003) | Nidek Co., Ltd. | 2000-10-25 |
| ROTATIONAL ANGIOPLASTY SYSTEM WITH ROTALINK PLUS EXCHANGEABLE CATHETER/ADVANCER (P900056/S056) | Boston Scientific Corp | 2000-10-24 |
| ST. JUDE MEDICAL MECHANICAL HEART VALVE (P810002/S054) | ABBOTT MEDICAL | 2000-10-23 |
| ACRYSOF MULTI-PIECE POSTERIOR CHAMBER (IOL) (P930014/S008) | Alcon Laboratories, Inc. | 2000-10-23 |
| TCI HEARTMATE VE LVAS (P920014/S013) | Thoratec Corp | 2000-10-20 |
| NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM (P000015) | Cochlear Americas | 2000-10-20 |
| INTERSTIM SACRAL NERVE STIMULATION SYSTEM (P970004/S009) | Medtronic Neuromodulation | 2000-10-18 |