| FREEZOR CARDIAC CRYOABLATION CATHETER (P020045/S004) | Medtronic Cryocath, LP | 2004-05-03 |
| BIOGLUE SURGICAL ADHESIVE IN SYRINGE DELIVERY SYSTEM (MODEL BG3500) (P010003/S003) | Cryolife, Inc. | 2004-05-03 |
| ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLATFORM AND ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS PLATFORM (P930038/S039) | Terumo Medical Corporation | 2004-04-30 |
| TACHOS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS AND PROGRAMMER SOFTWARE VERSION A-K00.1.U/5 (P000009/S011) | Biotronik, Inc. | 2004-04-22 |
| PERCLOSE PROGLIDE 6FR SUTURE-MEDIATED CLOSURE (SMC) SYSTEM (P960043/S053) | Abbott Vascular, Inc. | 2004-04-22 |
| RIATA DEFIBRILLATION LEAD FAMILY (P950022/S018) | ABBOTT MEDICAL | 2004-04-21 |
| ALTO 2 DR MODEL 624 AND ALTO 2 VR MODEL 625 (P980049/S014) | MicroPort CRM USA, Inc. | 2004-04-15 |
| ZENITH FLEX AAA ENDOVASCULAR GRAFT AND H&L-B ONE-SHOT INTRODUCTION SYSTEM (P020018/S003) | Cook, Inc. | 2004-04-15 |
| 7F FREEZOR CARDIAC CYROABLATION CATHETER AND CCT.2 CRYOCONSOLE SYSTEM (P020045/S001) | Medtronic Cryocath, LP | 2004-04-13 |
| MEDTRONIC GEM III AT WITH APP, DEVICE MODEL 7276 AND SOFTWARE MODEL 9974 (P980050/S015) | Medtronic, Inc. | 2004-04-12 |
| EPIC + DR/VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM AND THE MODEL 3307 V 4.6M SOFTWARE (P830045/S091) | St. Jude Medical, Inc. | 2004-04-09 |
| EPIC + DR/VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (P880086/S099) | ABBOTT MEDICAL | 2004-04-09 |
| EPIC+ VR MODEL V-196T AND EPIC+ DR MODEL V-239T (P910023/S072) | ABBOTT MEDICAL | 2004-04-09 |
| MEDTRONIC MODEL 7278 MAXIMO DR DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR AND MODEL 7232 MAXIMO VR SINGLE CHAM (P980016/S042) | Medtronic Cardiac Rhythm Disease Management | 2004-04-08 |
| ANGIO-SEAL VASCULARCLOSURE DEVICE (P930038/S038) | Terumo Medical Corporation | 2004-04-08 |
| NAVISTAR DS DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER (P010068/S003) | Biosense Webster, Inc. | 2004-04-02 |
| PHILOS DR-T PULSE GENERATOR AND A-K00.1.U/5 PROGRAMMER SOFTWARE (P950037/S037) | Biotronik, Inc. | 2004-03-31 |
| ENPULSE IMPLANTABLE PULSE GENERATOR, MODELS E1DR01, E1DR03, E1DR06, E1DR21 AND MODEL 9991 V 2.0 APPLICATION SOFTWARE (P980035/S036) | Medtronic, Inc. | 2004-03-31 |
| PHILOS II DR, PHILOS II D, PHILOS II DR-T, PHILOS II SLR, PHILOS II SR, PHILOS II S, AND PROGRAMMER SOFTWARE VERSION A-U (P950037/S036) | Biotronik, Inc. | 2004-03-31 |
| PROTOS DR/CLS, PROTOS VR/CLS, AXIOS DR, AXIOS D, AXIOS S, AXIOS SR, AND AXIOS SLR PULSE GENERATORS WITH PROGRAMMER SOFT (P950037/S032) | Biotronik, Inc. | 2004-03-31 |
| CARDIOSEAL SEPTAL OCCULUSION SYSTEM WITH QWIK LOAD (P000049/S011) | Nmt Medical, Inc. | 2004-03-24 |
| MULTI-LINK VISION CORONARY STENT SYSTEM (P020047/S002) | Abbott Vascular | 2004-03-22 |
| (ASC)MULTI-LINK CORONARY STENT SYSTEM (P970020/S045) | Abbott Vascular, Inc. | 2004-03-22 |
| SMART CONTROL NITINOL STENT SYSTEM (P020036/S002) | Cordis US Corporation | 2004-03-19 |
| VENTAK VITALITY AVT AICD SYSTEM (MODEL A135) (P960040/S042) | Boston Scientific | 2004-03-19 |
| BELOS A+ /BELOS A+/T, /KAINOX A+ 75/15, /KAINOX A+ 75/17 (P000009/S008) | Biotronik, Inc. | 2004-03-19 |
| PERCLOSE PROGLIDE 6 FRENCH SUTURE MEDIATED CLOSER (SMC) SYSTEM (P960043/S052) | Abbott Vascular, Inc. | 2004-03-18 |
| ORCHESTRA PROGRAMMER (P980049/S013) | MicroPort CRM USA, Inc. | 2004-03-16 |
| GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEM (P000052/S023) | Guidant Corp. | 2004-03-16 |
| ALTO DR MODEL 614, ALTO VR MODEL 615, ALTO 2 DR MODEL 624 AND ALTO 2 VR MODEL 625 (P980049/S012) | MicroPort CRM USA, Inc. | 2004-03-15 |
| KENTROX SL ICD LEADS (P980023/S016) | Biotronik, Inc. | 2004-03-12 |
| VOYAGER OTW CORONARY DILATION CATHETER (P810046/S214) | Advanced Cardiovascular Systems, Inc. | 2004-03-12 |
| MEDTRONIC MODEL 5076 LEAD (P930039/S018) | Medtronic, Inc. | 2004-03-10 |
| CONTAK CD 2 (MODELS H115, H119) AND APPLICATION SOFTWARE MODEL 2844 (P010012/S023) | Boston Scientific Corp | 2004-03-09 |
| VENTAK PRIZM AICD, VENTAK PRIZM HE AICE, VENTAK PRIZM 2 AICD AND VITALITY DS/EL AICD SYSTEMS (P960040/S041) | Boston Scientific | 2004-03-09 |
| MEDTRONIC ONYX SYSTEM, DEVICE MODEL 7290CX AND SOFTWARE MODEL 9999 (P980016/S040) | Medtronic Cardiac Rhythm Disease Management | 2004-03-08 |
| VITALITY 2 AICD SYSTEM (MODELS T165, T167, T175, T177), MODEL 2857 APPLICATION SOFTWARE (VERSION 2.2) AND QUICK PROFILE (P960040/S039) | Boston Scientific | 2004-03-08 |
| MEDTRONIC MODEL 2490D CARELINK MONITOR (P890003/S074) | Medtronic, Inc. | 2004-03-08 |
| SELOX SR STEROID-ELUTING ACTIVE FIXATION ENDOCARDIAL PACING LEAD MODELS SR45, SR53, SR60 SR 53,SELOX SR 60 (P950037/S034) | Biotronik, Inc. | 2004-03-08 |
| MEDTRONIC MODEL 2490D CARELINK MONITORS AND MODEL 2491 DDMA SOFTWARE FOR ENPULSE MODELS (P980035/S035) | Medtronic, Inc. | 2004-03-08 |
| GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEMS (P000052/S021) | Guidant Corp. | 2004-03-04 |
| BX VELOCITY STENT WITH RAPTOR OVER-THE-WIRE (OTW) OR RAPTORRAIL (RX) STENT DELIVERY SYSTEMS (SDS) - SAPHENOUS VEIN GRAFN (P900043/S042) | Cordis Corp. | 2004-03-04 |
| TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE) (P030025) | Boston Scientific Corp | 2004-03-04 |
| CONTAK RENEWAL TR, MODELS H120, H125 (P030005/S001) | Guidant Corp. | 2004-03-03 |
| ENDOTAK RELIANCE G/SG LEAD MODELS 0180-0187 (P910073/S043) | Boston Scientific | 2004-03-02 |
| ATS OPEN PIVOT BILEAFLET HEART VALVE (P990046/S010) | Medtronic Ats Medical, Inc. | 2004-02-27 |
| GORE EXCLUDER BIFURCATED ENDOPROSTHESIS (P020004/S005) | W. L. Gore & Associates, Inc. | 2004-02-25 |
| STOCKERT 70 RADIOFREQUENCY GENERATOR (P990071/S004) | Biosense Webster, Inc. | 2004-02-24 |
| EPT-1000 XP CARDIAC ABLATION SYSTEM (P020025/S001) | Boston Scientific | 2004-02-23 |
| MEDTRONIC ENPULSE IMPLANTABLE PULSE GENERATOR AND MODEL 9991 APPLICATION SOFTWARE (P980035/S032) | Medtronic, Inc. | 2004-02-20 |
| MEDTRONIC SIGMA MODELS SS106, SSR306, SC203, SDR203, SD303, SDR303, DR353 AND SVDD303 (P980035/S033) | Medtronic, Inc. | 2004-02-17 |
| NOVOSTE BETA-CATH SYSTEM (P000018/S035) | Best Vascular, Inc. | 2004-02-17 |
| INTRACOIL PERIPHERAL STENT (P000033/S001) | Medtronic Vascular, Inc. | 2004-02-13 |
| SYMPHONY/ELA RHAPSODY ROM MASK T3 (VERSION GXD T3) (P950029/S019) | MicroPort CRM USA, Inc. | 2004-02-13 |
| EASYTRAK IS-1 LEAD, MODELS 4535, 4536, 4537, 4538; EASYTRAK 1 LEAD MODELS 4510, 4511, 4512, 4513 (P010012/S022) | Boston Scientific Corp | 2004-02-12 |
| ZENITH AAA ENDOVASCULAR GRAFT AND H&L-B ONE-SHOT INTRODUCTION SYSTEM (P020018/S002) | Cook, Inc. | 2004-02-12 |
| PERCLOSE PROGLIDE 6 FRENCH SUTURE MEDIATED CLOSURE SYSTEM (P960043/S048) | Abbott Vascular, Inc. | 2004-02-11 |
| SELUTE (P950001/S010) | Boston Scientific | 2004-02-10 |
| MERIDIAN DISCOVERY (P940031/S030) | Boston Scientific | 2004-02-10 |
| FINELINE/ THINLINE (P960004/S024) | Boston Scientific | 2004-02-10 |
| SWEET TIP RX/SWEET PICOTIP RX/FLEXTEND (P960006/S009) | Boston Scientific | 2004-02-10 |
| ENDOTAK/ ENDURANCE/ RELIANCE (P910073/S044) | Boston Scientific | 2004-02-10 |
| RES-Q (P940008/S018) | Boston Scientific | 2004-02-10 |
| CONTAK CD/CD2/RENEWAL/EASYTRAK (P010012/S021) | Boston Scientific Corp | 2004-02-10 |
| VENTAK (P830060/S053) | Boston Scientific | 2004-02-10 |
| VENTAK AV/ PRIZM/PRIZM2/ VITALITY (P960040/S040) | Boston Scientific | 2004-02-10 |
| VENTAK PRX/ MINI III/ MINI IV (P910077/S044) | Boston Scientific | 2004-02-10 |
| CHILLI II COOLED ABLATION CATHETER (P980003/S012) | Boston Scientific Corp | 2004-02-09 |
| CHILLI AND CHILLI RPM COOLED ABLATION SYSTEM (P990054/S005) | Boston Scientific Corp | 2004-02-09 |
| MEDTRONIC CAPSUREFIX NOVUS MODEL 4076 LEAD (P930039/S017) | Medtronic, Inc. | 2004-02-09 |
| CONTAK CD AND RENEWAL CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (P010012/S017) | Boston Scientific Corp | 2004-02-06 |
| MEDTRONIC INSYNC 11 PROTECT MODEL 7295 WITH THE MODEL 9992 APPLICATION SOFTWARE (P010031/S008) | Medtronic Cardiac Rhythm Disease Management | 2004-02-06 |
| VENTAK AV, PRIZM, VITALITY, VITALITY AVT IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P910077/S041) | Boston Scientific | 2004-02-06 |
| VENTAK PRX AND MINI IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P960040/S036) | Boston Scientific | 2004-02-06 |
| MEDTRONIC RF ENHANCR II FAMILY OF ABLATION CATHETERS (P930029/S021) | Medtronic, Inc. | 2004-02-05 |
| CHILLI COOLED ABLATION CATHETERS (P980003/S009) | Boston Scientific Corp | 2004-02-05 |
| ZENITH AAA ENDOVASCULAR GRAFT AND H&L-B ONE-SHOT INTRODUCTION SYSTEM (P020018/S001) | Cook, Inc. | 2004-02-02 |
| VERITY ADX XL VDR MODEL 5456I PULSE GENERATOR (P880086/S098) | ABBOTT MEDICAL | 2004-01-30 |
| ANEURX STENT GRAFT WITH XPEDIENT DELIVERY SYSTEM (P990020/S015) | Medtronic Vascular | 2004-01-30 |
| VERITY ADX XL VDR MODEL 5456I PULSE GENERATOR (P830045/S090) | St. Jude Medical, Inc. | 2004-01-30 |
| PERIMOUNT PERICARDIAL BIOPROSTHESIS, MODELS 2700, 2800 (PERIMOUNT RSR), 6900P (PERIMOUNT PLUS) AND 3000 (P860057/S022) | Edwards Lifesciences, LLC | 2004-01-26 |
| CONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL 2865 VERSION 1.8 APPLICATION SOFTWARE (P030005) | Guidant Corp. | 2004-01-26 |
| MOSAIC PORCINE BIOPROSTHESIS MODELS 305, 310 (P990064/S009) | Medtronic, Inc. | 2004-01-23 |
| HANCOCK II BIOPROTHESIS MODELS T505, T510 (P980043/S004) | Medtronic, Inc. | 2004-01-23 |
| QWIKSTAR DS DIAGNOSTIC/ABLATION CATHETER (P010068/S002) | Biosense Webster, Inc. | 2004-01-14 |
| ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S079) | Boston Scientific Corp | 2004-01-08 |
| EPT-1000 XP RF ABLATION SYSTEMS (P020025/S003) | Boston Scientific | 2004-01-07 |
| ROTOBLATOR ROTATIONAL ANGIOPLASTY SYSTEM WIRE (P900056/S080) | Boston Scientific Corp | 2004-01-07 |
| EPT-1000 CARDIAC ABLATION SYSTEMS (P920047/S022) | Boston Scientific Corp | 2004-01-07 |
| RADIUS CORONARY STENT WITH DELIVERY SYSTEM (P970061/S020) | Boston Scientific Scimed, Inc. | 2004-01-07 |
| PTCA CATHETERS (P880027/S063) | Boston Scientific | 2004-01-07 |
| PTCA/PERFUSION CATHETERS (P860019/S199) | Scimed Life Systems, Inc. | 2004-01-07 |
| CHILLI COOLED ABLATION SYSTEMS (P990054/S007) | Boston Scientific Corp | 2004-01-07 |
| CHILLI COOLED ABALATION SYSTEMS (P980003/S011) | Boston Scientific Corp | 2004-01-07 |
| WALLSTENT LILIAC ENDOPROSTHESIS (P940019/S017) | Boston Scientific Scimed, Inc. | 2004-01-07 |
| AORTIC VALVULOPLASTY BALLOON DILATATION CATHETER (P880065/S009) | Boston Scientific Corp | 2004-01-07 |
| WALLSTENT VENOUS ENDOPROSTHESIS (P980033/S009) | Boston Scientific Corporation | 2004-01-07 |
| CUTTING BALLOON (P950020/S009) | Boston Scientific Corp | 2004-01-07 |
| WALLENSTENT TIPS ENDOPROSTHESIS (P930031/S020) | Boston Scientific Corp | 2004-01-07 |
| EXPRESS CORONARY STENT SYSTEM (P020009/S014) | Boston Scientific Scimed, Inc. | 2004-01-07 |