| CYBERLITH (P800019/S012) | Boston Scientific | 2004-12-22 |
| VENTAK P2, VENTAK P3 (P930035/S014) | Boston Scientific | 2004-12-22 |
| VENTAK P (P890061/S016) | Boston Scientific | 2004-12-22 |
| RES-Q (P940008/S020) | Boston Scientific | 2004-12-22 |
| VENTAK, BIPOLAR ENDOCARDIAL (P830060/S057) | Boston Scientific | 2004-12-22 |
| COSMOS (P830026/S079) | Boston Scientific | 2004-12-22 |
| VENTAK AV, VENTAK VR, VENTAK PRIZM, VITALITY, VITALITY 2 (P960040/S050) | Boston Scientific | 2004-12-22 |
| RELAY (P910020/S026) | Boston Scientific | 2004-12-22 |
| SELUTE, SELUTE PICOTIP (P950001/S013) | Boston Scientific | 2004-12-22 |
| CYBERTACH (P820022/S004) | Boston Scientific | 2004-12-22 |
| FINELINE, FINELINE II (P960004/S027) | Boston Scientific | 2004-12-22 |
| KAPPA 700, KAPPA 900, ENPULSE (P980035/S040) | Medtronic, Inc. | 2004-12-20 |
| CONTAK RENEWAL 1 CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (P010012/S038) | Boston Scientific Corp | 2004-12-15 |
| ELAVIEW 1.26 UG APPLICATION SOFTWARE FOR THE ORCHESTRA PROGRAMMER; RAM PATCHES ALTO P4 AND ALTO2 P3; AND HSO 2.70 SOFTWA (P980049/S017) | MicroPort CRM USA, Inc. | 2004-12-08 |
| GORE VIATORR TIPS (P040027) | W. L. Gore & Associates, Inc. | 2004-12-06 |
| GORE EXCLUDER BIFURCATED ENDOPROSTHESIS (P020004/S008) | W. L. Gore & Associates, Inc. | 2004-12-02 |
| EXPRESS2 STENT DELIVERY SYSTEM (P020009/S018) | Boston Scientific Scimed, Inc. | 2004-11-30 |
| TAXUS EXPRESS2 STENT DELIVERY SYSTEM (P030025/S012) | Boston Scientific Corp | 2004-11-30 |
| EASYTRAK 3 IS-1 LEAD MODELS: 4548/4549/4550 (P010012/S032) | Boston Scientific Corp | 2004-11-24 |
| TAXUS EXPRESS2 CORONARY STENT SYSTEM (P030025/S008) | Boston Scientific Corp | 2004-11-22 |
| SELECTION AFM, VITATRON C60 DR, C20 SR, T60 DR, AND T20 SR PACING SYSTEMS (P990001/S016) | Medtronic, Inc. | 2004-11-22 |
| IDENTITY/IDENTITY ADX, INFINITY AND INTEGRITY FAMILIES OF PACEMAKERS (P880086/S101) | ABBOTT MEDICAL | 2004-11-22 |
| STELIX/STELIX II STEROID ELUTING PACING LEADS; EASYTURN/EASYTURN ACCESSORY SYTLET KITS (P020030/S001) | MicroPort CRM USA, Inc. | 2004-11-22 |
| CONTAK CD, CONTAK CD 2, EASYTRAK, EASYTRACK 2, EASYTRAK 3, CONTAK RENEWAL, CONTAK RENEWAL 3 (P010012/S034) | Boston Scientific Corp | 2004-11-19 |
| COSMOS (P830026/S078) | Boston Scientific | 2004-11-19 |
| SELUTE,SELUTE PICOTIP (P950001/S012) | Boston Scientific | 2004-11-19 |
| INTERTACH (P860007/S022) | Boston Scientific | 2004-11-19 |
| VENTAK AV,VENTAK VR,VENTAK PRIZM,VITALITY,VITALITY 2 (P960040/S048) | Boston Scientific | 2004-11-19 |
| ENDOTAK,ENDOTAK ENDURANCE, ENDOTAK RELIANCE (P910073/S048) | Boston Scientific | 2004-11-19 |
| DELTA, VISTA (P840068/S042) | Boston Scientific | 2004-11-19 |
| VENTAK P3 (P930035/S013) | Boston Scientific | 2004-11-19 |
| VIGOR,DISCOVERY,MERIDIAN (P940031/S032) | Boston Scientific | 2004-11-19 |
| RELAY (P910020/S025) | Boston Scientific | 2004-11-19 |
| RES-Q (P940008/S019) | Boston Scientific | 2004-11-19 |
| VENTAK BIPOLAR ENDOCARDIAL (P830060/S056) | Boston Scientific | 2004-11-19 |
| CYBERLITH (P800019/S011) | Boston Scientific | 2004-11-19 |
| SWEET TIP RX, SWEET PICOTIP RX, FLEXTEND (P960006/S012) | Boston Scientific | 2004-11-19 |
| VENTAK P (P890061/S015) | Boston Scientific | 2004-11-19 |
| VENTAK PRX, VENTAK MINI (P910077/S047) | Boston Scientific | 2004-11-19 |
| CONTACK RENEWAL TR (P030005/S004) | Guidant Corp. | 2004-11-19 |
| CYBERTACH (P820022/S003) | Boston Scientific | 2004-11-19 |
| FINELINE,FINELINE II (P960004/S026) | Boston Scientific | 2004-11-19 |
| MOSAIC PORCINE (MODEL 305) AND HANCOCK II (MODEL T505) BIOPROSTHESES (P990064/S010) | Medtronic, Inc. | 2004-11-18 |
| MOSAIC PORCINE (MODEL 305) AND HANCOCK II (MODEL T505) BIOPROSTHESES (P980043/S005) | Medtronic, Inc. | 2004-11-18 |
| THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM (P870072/S031) | Thoratec Laboratories Corp. | 2004-11-17 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT ON THE RAPTOR OVER-THE-WIRE DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVER (P020026/S005) | Cordis Corp. | 2004-11-17 |
| ALTO 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P980049/S016) | MicroPort CRM USA, Inc. | 2004-11-17 |
| ST. JUDE MEDICAL EPIC HF DEFIBRILLATOR MODEL V-337, ST. JUDE MEDICAL ATLAS+ HF DEFIBRILLATOR MODEL V-343 (P030054/S001) | ABBOTT MEDICAL | 2004-11-17 |
| CELSIUS DS 8MM DIAGNOSTIC/ABLATION TIP CATHETER (P010068/S005) | Biosense Webster, Inc. | 2004-11-16 |
| TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S011) | Boston Scientific Corp | 2004-11-11 |
| SELOX ST/JT STEROID-ELUTING PASSIVE-FIXATION ENDOCARDIAL PACKING LEAD MODELS SELOX ST 53, SELOX ST 60, SELOX JT 45 & 53 (P950037/S038) | Biotronik, Inc. | 2004-11-10 |
| BIOSENSE WEBSTER NAVISTAR/CELSIUS THERMO COOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS (P030031) | Biosense Webster, Inc. | 2004-11-05 |
| ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS (P930038/S041) | Terumo Medical Corporation | 2004-11-04 |
| ANGIOLINK VASCULAR CLOSURE SYSTEM (P040022) | Medtronic Vascular | 2004-11-03 |
| DIAGNOSTIC RESTORATION TOOL (DRT) MODEL 2725, VERSION 2.2 (P960040/S046) | Boston Scientific | 2004-10-29 |
| PRISM/PRIZM 2/ CONTAK CD2/VITALITY DS/EL MODEL 2844 VERSION 3.8 (P010012/S033) | Boston Scientific Corp | 2004-10-29 |
| ENDOLOGIX POWERLINK SYSTEM (P040002) | Endologix, LLC | 2004-10-29 |
| MODEL 2844 VERSION 3.8 (P960040/S047) | Boston Scientific | 2004-10-29 |
| ANEURX STENT GRAFT WITH XCELERANT DELIVERY SYSTEM (P990020/S017) | Medtronic Vascular | 2004-10-28 |
| SYMPHONY & ELA RHAPSODY PACEMAKERS (P950029/S021) | MicroPort CRM USA, Inc. | 2004-10-27 |
| INSYNC SENTRY MODEL 7297 ICD AND MODEL 9998 APPLICATION SOFTWARE VERSION 1.2 (P010031/S015) | Medtronic Cardiac Rhythm Disease Management | 2004-10-26 |
| 9F FREEZOR MAX SURGICAL CARDIAC CRYOABLATION DEVICE (P020045/S006) | Medtronic Cryocath, LP | 2004-10-26 |
| EPIC HF CRT-D (P030054/S003) | ABBOTT MEDICAL | 2004-10-25 |
| 2490D/E CARELINK MONITORS (P890003/S078) | Medtronic, Inc. | 2004-10-25 |
| TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE) (P030025/S006) | Boston Scientific Corp | 2004-10-21 |
| CRYOLIFE BIOGLUE SURGICAL ADHESIVE (P010003/S004) | Cryolife, Inc. | 2004-10-20 |
| GORE EXCLUDER BIFURCATED ENDOPROSTHESIS (P020004/S007) | W. L. Gore & Associates, Inc. | 2004-10-20 |
| INSYNC MAXIMO MODEL 7303 AND MODEL 9998 APPLICATION SOFTWARE, VERSION 1.2 (P010031/S017) | Medtronic Cardiac Rhythm Disease Management | 2004-10-19 |
| MODEL 2490G/ 2490H/2490J CARELINK MONITORS FOR USE WITH MODEL 2491 DDMA SOFTWARE (P890003/S077) | Medtronic, Inc. | 2004-10-19 |
| SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T) (P030011) | Syncardia Systems, LLC | 2004-10-15 |
| CHILLI II COOLED ABLATION CATHETER (P980003/S013) | Boston Scientific Corp | 2004-10-14 |
| EPT-1000XP CARDIAC ABLATION SYSTEM (P020025/S007) | Boston Scientific | 2004-10-12 |
| NOVOSTE BETA - CATH SYSTEM (P000018/S041) | Best Vascular, Inc. | 2004-10-04 |
| STAT PACE II (P840002/S011) | Cardiocommand, Inc. | 2004-10-01 |
| KENTROX RV-S STEROID AND KENTROX SL-2 STEROID IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LEADS (P980023/S017) | Biotronik, Inc. | 2004-09-30 |
| ACCULINK CAROTID STENT SYSTEM AND RX ACCULINK CAROTID STENT SYSTEM (P040012/S001) | Abbott Vascular | 2004-09-24 |
| MARQUIS VR, DR/MAXIMO/ MAXIMO DR/ INTRINSIC 30/INTRINSIC (P980016/S045) | Medtronic Cardiac Rhythm Disease Management | 2004-09-22 |
| KAPPA 700, 800, 900/SIGMA/ENPULSE (P980035/S039) | Medtronic, Inc. | 2004-09-22 |
| INSYNC MARQUIS/INSYNC III (MARQUIS)/INSYNC II (MARQUIS)/INSYNC II (PROTECT)/INSYNC MAXIMO/PRODIGY DR (P010031/S016) | Medtronic Cardiac Rhythm Disease Management | 2004-09-22 |
| VITATRON LEGACY 11 DR (P890003/S076) | Medtronic, Inc. | 2004-09-22 |
| MEDTRONIC KAPPA 400 SERIES PACEMAKERS (P970012/S016) | Medtronic, Inc. | 2004-09-22 |
| PROGRAMMER SOFTWARE A-K00.2.U IN THE LEXOS, BELOS AND CARDIAC AIRBAG IMPLANTABLE CARDIOVERTER DEFIBRILLATS (P000009/S013) | Biotronik, Inc. | 2004-09-17 |
| INSYNC 8040 DEVICES (P010015/S014) | Medtronic, Inc. | 2004-09-15 |
| MODEL 9879 SOFTWARE FOR THERA/THERA-I/PRODIGY DEVICES, MODEL 9849 SOFTWARE FOR THE LEGACY II/VISA DEVICES, MODEL 9847... (P890003/S075) | Medtronic, Inc. | 2004-09-15 |
| CONTAK CD (MODEL 1823), CONTAK CD 2 (MODELS H115 AND H119), RENEWAL (MODEL H135), RENEWAL 3 (MODELS H170, H175, H177, A (P010012/S026) | Boston Scientific Corp | 2004-09-14 |
| LEAD ADAPTERS MODEL NUMBER 6024 (P910073/S047) | Boston Scientific | 2004-09-13 |
| ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS, MODELS 610130 AND 610131 (P930038/S040) | Terumo Medical Corporation | 2004-09-13 |
| THORATEC PVAD SYSTEM AND TLC-II PORTABLE VAD DRIVER (P870072/S029) | Thoratec Laboratories Corp. | 2004-09-13 |
| CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIK LOAD (P000049/S015) | Nmt Medical, Inc. | 2004-09-13 |
| MULTI-LINK VISION CORONARY STENT SYSTEM - 2.75 MM (P020047/S004) | Abbott Vascular | 2004-09-10 |
| MULTI-LINK MINI VISION CORONARY STENT SYSTEM (P020047/S003) | Abbott Vascular | 2004-09-10 |
| GATED SUTURE TRIMMER ACCESSORY (P960043/S056) | Abbott Vascular, Inc. | 2004-09-10 |
| NAVISTAR DS 8 MM DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER AND CELSIUS DS 8 MM DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER (P010068/S004) | Biosense Webster, Inc. | 2004-09-10 |
| GEM III AT WITH APP DEVICE MODEL 7276 AND SOFTWARE MODEL 9974 (P980050/S016) | Medtronic, Inc. | 2004-08-31 |
| SURESTAT ARTERIAL CLOSURE SYSTEM (P010049/S012) | Sub-Q, Inc. | 2004-08-31 |
| ACCULINK CAROTID STENT SYSTEM AND RX ACCULINK CAROTID STENT SYSTEM (P040012) | Abbott Vascular | 2004-08-30 |
| PERCLOSE PROGLIDE 6 FR. SUTURE-MEDIATED CLOSURE (SMC) SYSTEM (P960043/S055) | Abbott Vascular, Inc. | 2004-08-30 |
| EXTERNAL PULSE GENERATOR MODEL 2A, TAPSCOPE 500 SERIES ESOPHAGEAL STETHOSCOPE AND PACING CATHETER, TAPSCOPE 210 ESOPHAGR (P840002/S012) | Cardiocommand, Inc. | 2004-08-27 |
| EXTERNAL PULSE GENERATOR MODEL 2A, TAPSCOPE 500 SERIES ESOPHAGEAL STETHOSCOPE AND PACING CATHETER, TAPSCOPE 210 ESOPHAGR (P860008/S018) | Cardio Command | 2004-08-27 |
| MEDTRONIC MAXIMO VR MODELS 7232B AND 7232 IMPLANTABLE CARDIAC DEFIBRILLATORS (ICDS) (P980016/S044) | Medtronic Cardiac Rhythm Disease Management | 2004-08-25 |