| ACTIVA TREMOR CONTROL THEREAPY SYSTEM (P960009/S019) | Medtronic, Inc. | 2001-12-31 |
| VASCULAR SOLUTIONS DUETT SEALING DEVICE (P990037/S007) | Vascular Solutions, Inc. | 2001-12-31 |
| PATHVYSION HER-2 DNA PROBE KIT (P980024/S001) | Abbott Molecular, Inc. | 2001-12-31 |
| POSTERIOR CHAMBER INTRAOCULAR LENSES (P970034/S008) | Aaren Scientific | 2001-12-31 |
| MEDTRONIC SIGMA AND MEDTRONIC 350 SERIES PULSE GENERATORS (P980035/S017) | Medtronic, Inc. | 2001-12-28 |
| THE CLOSER II 6FR. SUTURE-MEDIATED CLOSURE (SMC) SYSTEM (P960043/S035) | Abbott Vascular, Inc. | 2001-12-28 |
| TRANSCYTE HUMAN FIBROBLAST-DERIVED TEMPORARY SKIN SUBSTITUTE (P960007/S016) | Shire Regenerative Medicine | 2001-12-26 |
| COSTASIS/DYNASTAT SURGICAL HEMOSTAT (P990030/S002) | Angiotech Medical Device Technologies | 2001-12-21 |
| ATLAS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM (P830045/S080) | St. Jude Medical, Inc. | 2001-12-21 |
| ATLAS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM (P880086/S087) | ABBOTT MEDICAL | 2001-12-21 |
| NEPTUNE X-ACT/NEPTUNE X-ACT OTW BALLOON DILATATION CATHETER (P790017/S073) | Medtronic, Ireland | 2001-12-21 |
| ATLAS DR/VR IMPLANTABLE CARDIOVERTER/DEFIBRILLATOR (P910023/S058) | ABBOTT MEDICAL | 2001-12-21 |
| MODEL 2490A CARELINK MONITOR AND 2491 SOFTWARE (P980016/S021) | Medtronic Cardiac Rhythm Disease Management | 2001-12-21 |
| ALTO ICD MODELS 614 AND 615 (P980049/S006) | MicroPort CRM USA, Inc. | 2001-12-21 |
| PHOSPHORYLCHOLINE (PC) COATED BIODIVYSIOH SV STENT PREMOUNTED ON AN OVER-THE-WIRE (OTW) DELIVERY SYST SV OTW), AND PC C) (P000011/S003) | Abbott Vascular, Inc. | 2001-12-21 |
| MEDTRONIC CAPSURE SP MODEL 5024M (P930039/S013) | Medtronic, Inc. | 2001-12-19 |
| CAPSURE SP MODEL 5024M AND SUREFIX MODEL 5072 LEADSRIES (P850089/S050) | Medtronic Cardiac Rhythm Disease Management | 2001-12-19 |
| OXIFIRST(TM) FETAL SENSOR FS14-SERIES (P990053/S002) | Covidien, LLC | 2001-12-19 |
| MEDTRONIC HALL/EASY-FIT PROSTHETIC HEART VALVE (P790018/S040) | Medtronic Cardiac Surgery | 2001-12-19 |
| EPT-1000 CARDIAC ABLATION SYSTEM (P920047/S016) | Boston Scientific Corp | 2001-12-18 |
| GALILEO(TM) INTRAVASCULAR RADIOTHERAPY SYSTEM (P000052/S001) | Guidant Corp. | 2001-12-18 |
| FINELINE II STEROX LEADS (P960004/S020) | Boston Scientific | 2001-12-18 |
| WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST (P010030) | Zoll Manufacturing Corporation | 2001-12-18 |
| AMS ACTICON NEOSPHINCTER (P010020) | Boston Scientific Corp | 2001-12-18 |
| MOBILE SENOGRAPHE 2000D (P990066/S008) | GE Healthcare | 2001-12-18 |
| GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM (P000052/S003) | Guidant Corp. | 2001-12-17 |
| ANCURE ENDOGRAFT SYSTEM (P990017/S028) | Boston Scientific Corp | 2001-12-17 |
| COSEAL SURGICAL SEALANT (COSEAL) (P010022) | Angiotech Medical Device Technologies | 2001-12-14 |
| INTERSTIM SYSTEM (P970004/S019) | Medtronic Neuromodulation | 2001-12-14 |
| MODEL 7427V SYNERGY VERSITREL DUAL CHANNEL IMPLANTABLE PULSE GENERATOR (P840001/S058) | Medtronic Neuromodulation | 2001-12-14 |
| MEDTRONIC KAPPA 900/800 SERIES PACING SYSTEM (P980035/S014) | Medtronic, Inc. | 2001-12-14 |
| MCGHAN MEDICAL SALINE-FILLED BREAST IMPLANTS (P990074/S010) | Allergan | 2001-12-12 |
| SOFTCON(VIFILCON A) SOFT (HYDROPHILIC) CONTACT LENS(EXTENDED WEAR) (P820021/S030) | Alcon Laboratories, Inc. | 2001-12-12 |
| THERA/THERA-I FAMILY OF PULSE GENERATORS (P890003/S066) | Medtronic, Inc. | 2001-12-11 |
| CAPSURE AND CAPSURE NOVUS FAMILIES OF LEADS/ACCESSORIES (P850089/S049) | Medtronic Cardiac Rhythm Disease Management | 2001-12-11 |
| DEMA/DIVA IMPLANTABLE PULSE GENERATORS (P990001/S010) | Medtronic, Inc. | 2001-12-11 |
| CAPSURE EPI 4965/4968 (P950024/S005) | Medtronic, Inc. | 2001-12-11 |
| SPRINT FAMILY OF LEADS (P920015/S025) | Medtronic, Inc. | 2001-12-11 |
| ANCURE ENDOGRAFT SYSTEM (P990017/S029) | Boston Scientific Corp | 2001-12-11 |
| ACTIVA TREMOR CONTROL SYSTEM (P960009/S022) | Medtronic, Inc. | 2001-12-11 |
| KAPPA 400 (P970012/S012) | Medtronic, Inc. | 2001-12-11 |
| GEM III AT MODEL 7276 ICD/PULSE GENERATORS (P980050/S010) | Medtronic, Inc. | 2001-12-11 |
| CAPSUREFIX FAMILY OF LEADS (P930039/S012) | Medtronic, Inc. | 2001-12-11 |
| INSYNC IPG MODEL 8040 BIVENTRICULAR PULSE GENERATOR SYSTEM (P010015/S002) | Medtronic, Inc. | 2001-12-11 |
| GEM II FAMILY OF ICD/PULSE GENERATORS (P980016/S024) | Medtronic Cardiac Rhythm Disease Management | 2001-12-11 |
| MEDTRONIC SPINAL CORD STIMULATION SYSTEM (P840001/S059) | Medtronic Neuromodulation | 2001-12-11 |
| CAPSURE FAMILY OF LEADS/ACCESSORIES (P830061/S033) | Medtronic Cardiac Rhythm Disease Management | 2001-12-11 |
| KAPPA 700/600, SIGMA AND 350 SERIES FAMILIES OF PULSE GENERATORS (P980035/S016) | Medtronic, Inc. | 2001-12-11 |
| MEDTRONIC HALL PROSTHETIC HEART VALVES A7700 AND M7700 (P790018/S038) | Medtronic Cardiac Surgery | 2001-12-11 |
| GEM ICD/IPG (P900061/S051) | Medtronic Cardiac Rhythm Disease Management | 2001-12-11 |
| HYDRO THERMABLATOR. ENDOMETRIAL ABLATION SYSTEM (P000040/S002) | Axora Medical, Inc. | 2001-12-07 |
| DUPEN LONG-TERM EPIDURAL CATHETER (P860064/S010) | C.R. Bard, Inc. | 2001-12-07 |
| BAYER ACS:180 OR ADVIA CENTAUR COMPLEX PSA ASSAYS (P990055/S001) | Siemens Healthcare Diagnostics | 2001-12-07 |
| UROLOGIX TARGIS SYSTEM CONTROL UNIT (P970008/S015) | Urologix, LLC | 2001-12-06 |
| SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P990066/S004) | GE Healthcare | 2001-12-06 |
| AVITENE ULTRA WRAP COLLAGEN HEMOSTAT (N17600/S019) | Davol Inc., Sub. C. R. Bard, Inc. | 2001-12-06 |
| ORCEL BILAYERED CELLULAR MATRIX (P010016/S001) | Forticell Bioscience | 2001-12-06 |
| UROLOGIX TARGIS SYSTEM (P970008/S016) | Urologix, LLC | 2001-12-06 |
| MEDTRONIC INTERSTIM THERAPY FOR URINARY CONTROL (P970004/S018) | Medtronic Neuromodulation | 2001-12-05 |
| CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIKLOAD (P000049) | Nmt Medical, Inc. | 2001-12-05 |
| THE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEM (P000039) | ABBOTT MEDICAL | 2001-12-05 |
| FLEXI-CUT DIRECTIONAL DEBULKING SYSTEM (P890043/S037) | Abbott Vascular | 2001-12-05 |
| SYNCHROMED PROGRAMMABLE INFUSION PUMPS (P860004/S048) | Medtronic, Inc. | 2001-12-05 |
| MEDTRONIC HALL PROSTHETIC HEART VALVES A7700 AND M7700 (P790018/S039) | Medtronic Cardiac Surgery | 2001-12-04 |
| SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P990066/S010) | GE Healthcare | 2001-12-03 |
| BIOGLUE SURGICAL ADHESIVE (P010003) | Cryolife, Inc. | 2001-12-03 |
| GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER (P990026/S009) | Animas Corp. | 2001-11-30 |
| SUNLIGHT OMNISENSE 7000S (P990035/S004) | Beam-Med, Ltd. | 2001-11-30 |
| MICROSCAN RAPID GRAM POSITIVE FLUOROGENIC PANELS (P870049/S032) | Dade Intl., Inc. | 2001-11-30 |
| THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM (P870072/S015) | Thoratec Laboratories Corp. | 2001-11-30 |
| GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER (P990026/S010) | Animas Corp. | 2001-11-30 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P860057/S016) | Edwards Lifesciences, LLC | 2001-11-29 |
| RADIUS CORONARY STENT WITH SINGLE-OPERATOR EXCHANGE (SOE) DELIVERY SYSTEM (P970061/S012) | Boston Scientific Scimed, Inc. | 2001-11-29 |
| ECLIPSE TMR HOLMIUM LASER SYSTEM (P970029/S008) | Cryolife, Inc. | 2001-11-29 |
| QUANTTFERON-TB GOLD AND TB GOLD-IN-THE-TUBE (P010033) | Qiagen | 2001-11-28 |
| WAVSTAT (TM) OPTICAL BIOPSY SYSTEM (P990050/S003) | Spectra Science | 2001-11-28 |
| THE CLOSER AND CLOSER S SUTURE MEDIATED CLOSURE DEVICES (P960043/S033) | Abbott Vascular, Inc. | 2001-11-28 |
| IDENTITY SR MODEL 5172 PULSE GENERATOR (P910023/S057) | ABBOTT MEDICAL | 2001-11-27 |
| IDENTITY XL DR MODEL 5376 PULSE GENERATOR (P880086/S086) | ABBOTT MEDICAL | 2001-11-27 |
| IDENTITY PULSE GENERATOR MODEL DR 5370 (P830045/S079) | St. Jude Medical, Inc. | 2001-11-27 |
| TALENT AND BRIO PACEMAKERS (P950029/S015) | MicroPort CRM USA, Inc. | 2001-11-26 |
| BOSTON EQUALENS/BOSTON EQUALENS II (P860022/S053) | Bausch & Lomb | 2001-11-21 |
| MOSAIC PORCINE BIOPROSTHESIS (P990064/S005) | Medtronic, Inc. | 2001-11-21 |
| BARD STINGER AND STINGER S ABLATION CATHETER AND TEMPLINK EXTENSION CABLE (P000020/S005) | Boston Scientific Corp | 2001-11-21 |
| MENTOR POLYTEF PASTE /FOR INJECTION (N16420/S006) | Coloplast Corp. | 2001-11-21 |
| GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMS (P010032) | ABBOTT MEDICAL | 2001-11-21 |
| ANTERIOR CHAMBER INTRAOCULAR LENS (CATARACT) (P010027) | Aaren Scientific | 2001-11-21 |
| ANGIOJET(R) RHEOLYTIC THROMBECTOMY SYSTEM DRIVE UNIT (P980037/S003) | Boston Scientific Corp | 2001-11-20 |
| PUREVISION(TM)(BALAFILCON A) VISIBILITY TINTED CONTACT LENSES (P980006/S004) | Bausch & Lomb, Inc. | 2001-11-20 |
| CLOSER / CLOSER S 6 FRENCH SMC SYSTEMS (P960043/S031) | Abbott Vascular, Inc. | 2001-11-20 |
| ANGIOJET RHEOLYTIC XMI THROMBECTOMY CATHETER (P980037/S004) | Boston Scientific Corp | 2001-11-20 |
| APLIGRAF(R)(GRAFTSKIN) (P950032/S019) | Organogenesis, Inc. | 2001-11-19 |
| DERMABOND(R) TOPICAL SKIN ADHESIVE (P960052/S003) | Closure Medical Corp. | 2001-11-19 |
| ASCENSION MCP (P000057) | Smith & Nephew, Inc. | 2001-11-19 |
| PERMALENS (PERFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES (P780010/S022) | CooperVision, Inc. | 2001-11-16 |
| MEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESIS (P970031/S011) | Medtronic, Inc. | 2001-11-16 |
| WALLSTENT ENDOPROSTHESIS (P980033) | Boston Scientific Corporation | 2001-11-16 |
| INTERGEL ADHESION PREVENTION SOLUTION (P990015) | Lifecore Biomedical, Inc. | 2001-11-16 |
| MEDTRONIC GEM ICD (P900061/S050) | Medtronic Cardiac Rhythm Disease Management | 2001-11-14 |
| IMAGE CHECKER (CAD) SYSTEM, M100 (P970058/S011) | Hologic, Inc. | 2001-11-13 |