| NOVACOR N100PCQ LVAS (P980012/S005) | Worldheart, Inc. | 2004-01-02 |
| BLAZER II CARDIAC ABLATION CATHETHER, STEEROCATH-A CARDIAC ABLATION CATHETER,STEEROCATH-T CARDIAC ABLATION CATHETER (P920047/S021) | Boston Scientific Corp | 2003-12-31 |
| CHILLI COOLED ABLATION SYSTEM (P980003/S010) | Boston Scientific Corp | 2003-12-31 |
| CHILLI AND CHILLI RPM COOLED ABLATION SYSTEM (P990054/S006) | Boston Scientific Corp | 2003-12-31 |
| EPT-1000 CARDIAC ABLATION SYSTEM (P020025/S002) | Boston Scientific | 2003-12-31 |
| MEDTRONIC MODEL 2490E CARELINK MONITORS AND MODEL 2491 DDMA SOFTWARE FOR MAXIMO DR/VR, MODELS 7278 & 7232 AND INSYNC II (P980016/S039) | Medtronic Cardiac Rhythm Disease Management | 2003-12-29 |
| 2490D/E CARELINK MONITORS & MODEL 2491 DDMA SOFTWARE FOR INSYNC MARQUIS & MAXIMO VR/DR CAPABILITY (P890003/S073) | Medtronic, Inc. | 2003-12-29 |
| MEDTRONIC MODEL 2490E CARELINK MONITORS AND MODEL 2491 DDMA SOFTWARE FOR MAXIMO DR/VR, MODELS 7278 & 7232 AND INSYNC II (P010031/S011) | Medtronic Cardiac Rhythm Disease Management | 2003-12-29 |
| VENTAK PRIZM MODELS 1850 AND 1851 (P960040/S038) | Boston Scientific | 2003-12-24 |
| CONTAK CD 2 MODEL H115 (P010012/S019) | Boston Scientific Corp | 2003-12-24 |
| VENTAK MINI I, II,III (P910077/S043) | Boston Scientific | 2003-12-24 |
| QUICKSEAL CONTROL FEMORAL ARTERIAL CLOSURE SYSTEM (P010049/S009) | Sub-Q, Inc. | 2003-12-23 |
| ABIOMED AB5000 CIRCULATORY SUPPORT SYSTEM (P900023/S039) | Abiomed Cardiovascular, Inc. | 2003-12-23 |
| CONTAK CD/CD2, RENEWAL (P010012/S018) | Boston Scientific Corp | 2003-12-19 |
| MERIDIAN, DISCOVERY (P940031/S029) | Boston Scientific | 2003-12-19 |
| FINELINE II PACING LEADS (P960004/S023) | Boston Scientific | 2003-12-19 |
| VENTTAK AV/PRIZM/PRIZM2,VITALITY (P960040/S037) | Boston Scientific | 2003-12-19 |
| VENTAK MINI III,MINI IV (P910077/S042) | Boston Scientific | 2003-12-19 |
| ENPULSE INPLANTABLE PULSE GENERATOR (P980035/S030) | Medtronic, Inc. | 2003-12-18 |
| X-PRESS TRIMMER - ACCESSORY TO THE X-PRESS 6 FRENCH VASCULAR CLOSURE SYSTEM (P020035/S001) | St. Jude Medical, Inc. | 2003-12-18 |
| GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEMS (P000052/S022) | Guidant Corp. | 2003-12-18 |
| VENTAK AV, PRIZM, VITALITY, VITALITY AVT IMPLANTABLE CARDIOVERTER (P960040/S034) | Boston Scientific | 2003-12-17 |
| VENTAK PRX AND MINI IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P910077/S040) | Boston Scientific | 2003-12-17 |
| CONTAK CD AND RENEWAL CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (P010012/S015) | Boston Scientific Corp | 2003-12-17 |
| PHILOS DR-T PULSE GENERATOR/ICD BELOS VR-T,DR-T,ICD CARDIAC AIRBAG-T (P950037/S033) | Biotronik, Inc. | 2003-12-17 |
| ON-X PROSTHETIC HEART VALVE (P000037/S003) | On-X Life Technologies, Inc. | 2003-12-16 |
| COSEAL SURGICAL SEALANT (P030039) | Baxter Bio Science | 2003-12-12 |
| WALLSTENT ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P980033/S008) | Boston Scientific Corporation | 2003-12-11 |
| WALL STENT ILIAC ENDOPROSTHESIS (P940019/S016) | Boston Scientific Scimed, Inc. | 2003-12-11 |
| WALLSTENT TIPS ENDOPROSTHESIS (P930031/S018) | Boston Scientific Corp | 2003-12-11 |
| EXPRESS/EXPRESS2 CORONARY STENT SYSTEM (P020009/S013) | Boston Scientific Scimed, Inc. | 2003-12-10 |
| FREESTYLE SUBCORONARY BIOPROSTHESIS, MODIFIED SUBCORONARY CONFIGURATION, MODEL 995MS, SIZE 29 MM (P970031/S013) | Medtronic, Inc. | 2003-12-08 |
| PHOSPHORYLCHOLINE (PC) COATED BIODIVYSIO OPEN CELL (OC) STENT PREMOUNTED ON AN OVER-THE-WIRE (OTW) DELIVERY SYSTEM (P000011/S009) | Abbott Vascular, Inc. | 2003-12-08 |
| THORATEC HEARTMATE XVE AND VE LEST VENTRICULAR ASSIST SYSTEM (LVAS) (P920014/S022) | Thoratec Corp | 2003-12-02 |
| MEDTRONIC HALL PROSTHETIC HEART VALVE /HALL EASY FIT (P790018/S045) | Medtronic Cardiac Surgery | 2003-11-28 |
| THORATEC PARACORPOREAL VENTRICULAR ASSIST DEVICE (PVAD) SYSTEM AND TLC-II PORTABLE VAD DRIVER (P870072/S026) | Thoratec Laboratories Corp. | 2003-11-26 |
| CLOSER XL SUTURE MEDIATED CLOSURE (SMC) SYSTEM (P960043/S046) | Abbott Vascular, Inc. | 2003-11-25 |
| EPT-1000 CARDIAC ABLATION SYSTEM (P920047/S020) | Boston Scientific Corp | 2003-11-25 |
| PERCLOSE AT 6 FRENCH SUTURE MEDIATED CLOSER (SMC) SYSTEM (P960043/S049) | Abbott Vascular, Inc. | 2003-11-25 |
| LIVEWIRE TC CARDIAC ABLATION SYSTEM-CABLE 10X ETO REUSE/RESTERILIZATION, NEW EXTENSION CABLE (P960016/S012) | St Jude Medical | 2003-11-21 |
| BI-DIRECTIONAL TORQUE WRENCH(MODEL 6942) (P830060/S052) | Boston Scientific | 2003-11-21 |
| HEX WRENCH(MODEL 6501) (P930035/S011) | Boston Scientific | 2003-11-21 |
| THORATEC PARACORPOREAL VENTRICULAR ASSIST DEVICE (PVAD) SYSTEM AND TLC-II PORTABLE VAD DRIVER (P870072/S023) | Thoratec Laboratories Corp. | 2003-11-20 |
| NOVOSTE BETA-CATH SYSTEM (P000018/S039) | Best Vascular, Inc. | 2003-11-18 |
| KENTROX RV-S/KENTROX SL-S ICD LEADS (P980023/S012) | Biotronik, Inc. | 2003-11-18 |
| MEDTRONIC. KAPPA 400 SERIES PACEMAKERS (P970012/S015) | Medtronic, Inc. | 2003-11-17 |
| MEDTRONIC. GEM DR MODEL 7271 D (P980016/S036) | Medtronic Cardiac Rhythm Disease Management | 2003-11-17 |
| MEDTRONIC KAPPA 700/600 SERIES (P980035/S031) | Medtronic, Inc. | 2003-11-17 |
| INSYNC MODEL 7272 (P010031/S009) | Medtronic Cardiac Rhythm Disease Management | 2003-11-17 |
| MEDTRONIC INSYNC (TM) BIVENTRICAL PACING SYSTEM (P010015/S011) | Medtronic, Inc. | 2003-11-17 |
| SYNERGYST PULSE II GENERATOR (P890003/S072) | Medtronic, Inc. | 2003-11-17 |
| JEWEL AF 7250 (P980050/S014) | Medtronic, Inc. | 2003-11-17 |
| CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS, MODEL 3000 AORTIC (P860057/S018) | Edwards Lifesciences, LLC | 2003-11-14 |
| BELOS A+ AND BELOS A+/T ICD AND KAINOX A+ ICD LEAD (SINGLE-LEAD SYSTEM) (P000009/S009) | Biotronik, Inc. | 2003-11-13 |
| AMPLATZER DUCT OCCLUDER AND AMPLATZER DELIVERY AND EXCHANGE SYSTEM (P020024/S001) | ABBOTT MEDICAL | 2003-11-13 |
| HOUSECALL PLUS TRANSTELEPHONIC MONITORING SYSTEM WITH MODEL 3180-T TRANSMITTER (SOFTWARE VERSION 1.1) AND MODEL 3180-R (P910023/S071) | ABBOTT MEDICAL | 2003-11-06 |
| PHOSPHORYLCHOLINE (PC) COATED BIODIVYSIO SV AND OC OVER-THE-WIRE (OTW) STENT DELIVERY SYSTEMS (P000011/S010) | Abbott Vascular, Inc. | 2003-11-05 |
| ENDOTAK RELIANCE G AND SG ENDOCARDIAL DEFIBRILLATION LEAD (P910073/S041) | Boston Scientific | 2003-11-04 |
| SOFTWARE APPLICATION MODEL 2890 VERSION 4.10 (P940031/S028) | Boston Scientific | 2003-10-31 |
| SYNCHRONY MODEL 2020T PULSE GENERATOR (P880086/S097) | ABBOTT MEDICAL | 2003-10-31 |
| MODEL 3510 PROGRAMMER AND MODEL 3134 EXTERNAL VIDEO CABLE (P830045/S089) | St. Jude Medical, Inc. | 2003-10-31 |
| CARDIAC AIRBAG ICD, 345-424, CARDIAC AIRBAG-T ICD, 341-517, A-K00.1.U. PROGRAMMER SOFTWARE, 346-168 (P980023/S015) | Biotronik, Inc. | 2003-10-31 |
| THORATEC HEARTMATE XVE LVAS (P920014/S021) | Thoratec Corp | 2003-10-31 |
| 7F FREEZOR CARDIAC CRYOABLATION CATHETER AND CCT.2 CRYOCONSOLE SYSTEM (P020045/S002) | Medtronic Cryocath, LP | 2003-10-28 |
| EXPRESS/EXPRESS2 CORONARY STENT SYSTEM (P020009/S011) | Boston Scientific Scimed, Inc. | 2003-10-28 |
| SYMPHONY/ELA RHAPSODY PACEMAKER SYSTEM (P950029/S017) | MicroPort CRM USA, Inc. | 2003-10-24 |
| NIRFLEX PREMOUNTED STENT (P020040) | Medinol, Ltd. | 2003-10-24 |
| CONTAK RENEWAL AND CONTAK RENEWAL 3 (P010012/S016) | Boston Scientific Corp | 2003-10-24 |
| EXPRESS AND EXPRESS2 MONORAIL AND OVER-THE-WIRE CORONARY STENT SYSTEMS (P020009/S012) | Boston Scientific Scimed, Inc. | 2003-10-24 |
| NOVOSTE BETA-CATH SYSTEM (P000018/S027) | Best Vascular, Inc. | 2003-10-23 |
| MEDTRONIC MARQUIS DR 7274.MARQUIS VR 7230,MAXIMO DR 7278,MAXIMO VR 7232 (P980016/S038) | Medtronic Cardiac Rhythm Disease Management | 2003-10-23 |
| INSYNC MARQUIS MODEL 7277 AND THE INSYNC II MARQUIS MODEL 7289 (P010031/S010) | Medtronic Cardiac Rhythm Disease Management | 2003-10-23 |
| VITALITY AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEMS AND MODEL 2857 SOFTWARE, VERSION 1.6 (P960040/S032) | Boston Scientific | 2003-10-22 |
| ROTAWIRE FLOPPY GOLD GUIDE WIRE (P900056/S078) | Boston Scientific Corp | 2003-10-22 |
| ORCHESTRA PROGRAMMER (P980049/S011) | MicroPort CRM USA, Inc. | 2003-10-21 |
| CONTAK CD (MODEL 1823), CONTAK CD2 (MODEL H115, H119), RENEWAL (MODELS H135) AND RENEWAL 3 (MODELS H170,H175,H177,H179) (P010012/S014) | Boston Scientific Corp | 2003-10-21 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT ON THE RAPTOR OVER-THE-WIRE DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVER (P020026/S001) | Cordis Corp. | 2003-10-21 |
| ATLAS+ DR/BR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AND MODEL 3307 V.4.5A SOFTWARE (P910023/S069) | ABBOTT MEDICAL | 2003-10-17 |
| ATLAS+ DR/VR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS, AND MODEL 3307 V.4.5A SOFTWARE (P830045/S088) | St. Jude Medical, Inc. | 2003-10-17 |
| QUANTUM MAVERICK MONORAIL AND OVER-THE-WIRE PTCA CATHETERS (P860019/S195) | Scimed Life Systems, Inc. | 2003-10-17 |
| ATLAS+ DR/VR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AND MODEL 3307 V.4.5A SOFTWARE (P880086/S096) | ABBOTT MEDICAL | 2003-10-17 |
| GORE EXCLUDER BIFURCATED ENDOPROSTHESIS (P020004/S004) | W. L. Gore & Associates, Inc. | 2003-10-15 |
| NOVOSTE BETA-CATH SYSTEM (P000018/S038) | Best Vascular, Inc. | 2003-10-14 |
| ORCHESTRA PROGRAMMER (P980049/S010) | MicroPort CRM USA, Inc. | 2003-10-14 |
| BELOS AND CARDIAC AIRBAG FAMILIES (P000009/S010) | Biotronik, Inc. | 2003-10-14 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT ON THE RAPTOR OVER-THE-WIRE DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVER (P020026/S003) | Cordis Corp. | 2003-10-10 |
| NOVOSTE BETA-CATH SYSTEM (P000018/S037) | Best Vascular, Inc. | 2003-10-09 |
| NOVOSTE BETA-CATH SYSTEM (P000018/S036) | Best Vascular, Inc. | 2003-10-09 |
| MULTI-LINK RX AND OTW VISION CORONARY STENT SYSTEMS (P020047/S001) | Abbott Vascular | 2003-10-08 |
| MEDTRONIC MODEL 7278 MAXIMO DR ICD AND MODEL 7232 MAXIMO VR ICD SYSTEMS, WITH MODEL 9978 VERSION 1.0 APPLICATION SOFTWA (P980016/S037) | Medtronic Cardiac Rhythm Disease Management | 2003-10-06 |
| VENTAK VITALITY AVT AICD, MODELS A135 AND A155, MODEL 2920 PROGRAMMER WITH MODEL 2812 APPLICATION SOFTWARE VERSION 1.2 (P960040/S035) | Boston Scientific | 2003-10-06 |
| LIVEWIRE TC STEERABLE ELECTROPHYSIOLOGY CATHETER (P960016/S013) | St Jude Medical | 2003-10-03 |
| MEDTRONIC AT500 DDDRP PACING SYSTEM (MODEL AT501) AND MODEL 9968 SOFTWARE (P980035/S028) | Medtronic, Inc. | 2003-10-03 |
| DRIVER OVER-THE-WIRE, RAPID EXCHANGE, AND MULTI-EXCHANGE CORONARY STENT SYSTEMS (P030009) | Medtronic, Ireland | 2003-10-01 |
| X-PRESS 6 FRENCH VASCULAR CLOSURE SYSTEM (P020035) | St. Jude Medical, Inc. | 2003-09-30 |
| ALERT SYSTEM-COMPANION II (P990069/S001) | Dot Medical Products , Ltd. | 2003-09-29 |
| ABIOMED AB5000 CIRCULATORY SUPPORT SYSTEM (P900023/S038) | Abiomed Cardiovascular, Inc. | 2003-09-24 |
| ATS AVG (AORTIC VALVED GRAFT) (P990046/S009) | Medtronic Ats Medical, Inc. | 2003-09-23 |
| CARBOMEDICS PROSTHETIC HEART VALVE (P900060/S027) | Corcym S.r.l. | 2003-09-23 |
| MEDTRONIC HALL PROSTHETIC HEART VALVES (MODELS A7700 AND M7700) (P790018/S044) | Medtronic Cardiac Surgery | 2003-09-23 |