| MEDTRONIC ENPULSE IMPLANTABLE PULSE GENERATOR AND MODEL 9991 APPLICATIONS SOFTWARE (P980035/S034) | Medtronic, Inc. | 2004-08-25 |
| LIVEWIRE TC CARDIAC ABLATION SYSTEM (P960016/S010) | St Jude Medical | 2004-08-20 |
| MEDTRONIC LEFT VENTRICULAR PACING LEAD, ATTAIN BIPOLAR OTW MODEL 4194 (P010015/S012) | Medtronic, Inc. | 2004-08-20 |
| TAXUS EXPRESS PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE) (P030025/S004) | Boston Scientific Corp | 2004-08-18 |
| MEDTRONIC INTRINSIC MODELS 7287 AND 7288 ICD SYSTEMS (P980016/S043) | Medtronic Cardiac Rhythm Disease Management | 2004-08-18 |
| VITALITY ICD (P960040/S045) | Boston Scientific | 2004-08-17 |
| FRONTIER II BIVENTRICULAR PULSE GENERATOR WITH THE MODEL 3307, V4.8M PROGRAMMER SOFTWARE (P030035/S001) | ABBOTT MEDICAL | 2004-08-16 |
| EASYTRAK 2 AND EASYTRAK 2 IS-1 CORONARY VENOUS STEROID ELUTING BIPOLAR PACE/SENSE LEAD AND EASYTRAK FINISHING WIRE MODE0 (P010012/S024) | Boston Scientific Corp | 2004-08-06 |
| EASYTRAK 3 CORONARY VENOUS STERIOD ELUTING BIPOLAR PACE/SENSE LEAD (P010012/S025) | Boston Scientific Corp | 2004-08-06 |
| TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S001) | Boston Scientific Corp | 2004-08-06 |
| CONTAK RENEWAL TR (P030005/S003) | Guidant Corp. | 2004-08-06 |
| CONTAK RENEWAL AND CONTAK RENEWAL 3 (P010012/S029) | Boston Scientific Corp | 2004-08-06 |
| DRIVER MX2 CORONARY STENT SYSTEM (P030009/S001) | Medtronic, Ireland | 2004-08-04 |
| LIVEWIRE TC CARDIAC ABLATION SYSTEM (P960016/S011) | St Jude Medical | 2004-08-04 |
| THORATEC IMPLANTABLE VENTRICULAR ASSIST DEVICE (IVAD) (P870072/S027) | Thoratec Laboratories Corp. | 2004-08-03 |
| THORATEC PARACORPOREAL VENTRICULAR ASSIST DEVICE (PVAD) SYSTEM AND TLC-II PORTABLE VAD DRIVER (P870072/S028) | Thoratec Laboratories Corp. | 2004-08-03 |
| KENTROX RV STEROID AND KENTROX SL STEROID IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LEADS (P980023/S018) | Biotronik, Inc. | 2004-07-27 |
| BLAZER II XP AND BLAZER XP RPM CATHETERS (P920047/S024) | Boston Scientific Corp | 2004-07-27 |
| EPT-1000 XP CARDIAC ABLATION SYSTEM (P020025/S006) | Boston Scientific | 2004-07-27 |
| WALLSTENT (TIPS AND VENOUS)ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P930031/S022) | Boston Scientific Corp | 2004-07-22 |
| WALLSTENT (TIPS AND VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P980033/S011) | Boston Scientific Corporation | 2004-07-22 |
| FINISHING WIRE UNIVERSAL , MODEL NUMBERS 6002,6003,6004,6005,6007 (P010012/S030) | Boston Scientific Corp | 2004-07-21 |
| WORLD HEART NOVACOR N100PC AND N100PCQ :VAS (P980012/S006) | Worldheart, Inc. | 2004-07-21 |
| MODEL 3150 PACING SYSTEM ANALYZER WAND AND THE MODEL 3307 V4.7 PROGRAMMER SOFTWARE FOR USE WITH MODEL 3510 PROGRAMMERS (P880086/S100) | ABBOTT MEDICAL | 2004-07-21 |
| 7F FREEZOR CARDIAC CRYOABLATION CATHETER AND CCT.2 CRYOCONSOLE SYSTEM (P020045/S003) | Medtronic Cryocath, LP | 2004-07-19 |
| RX CHASSIS 3 CORONARY DILATATION CATHETER (P810046/S215) | Advanced Cardiovascular Systems, Inc. | 2004-07-16 |
| H&LB ONE-SHOT DELIVERY SYSTEM FOR USE WITH THE ZENITH FLEX AAA ENDOVASCULAR GRAFT (P020018/S004) | Cook, Inc. | 2004-07-15 |
| PERCLOSE A-T AND PROGLIDE 6 FRENCH SUTURE MEDIATED CLOSURE (SMC) SYSTEMS (P960043/S054) | Abbott Vascular, Inc. | 2004-07-15 |
| SYMPHONY AND ELA RHAPSODY PACEMAKERS (P950029/S020) | MicroPort CRM USA, Inc. | 2004-07-15 |
| ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM (P980037/S008) | Boston Scientific Corp | 2004-07-15 |
| DUETT PRO SEALING DEVICE AND DIAGNOSTIC DUETT PRO SEALING DEVICE (P990037/S021) | Vascular Solutions, Inc. | 2004-07-14 |
| VITATRON T60 DR AND T20 SR SYSTEMS (P990001/S015) | Medtronic, Inc. | 2004-07-12 |
| DUETT PRO SEALING DEVICE MODEL 1010 (P990037/S022) | Vascular Solutions, Inc. | 2004-07-09 |
| THORATEC HEARTMATE XVE AND VE LEFT VENTRICULAR ASSIST SYSTEM (LVAS) (P920014/S023) | Thoratec Corp | 2004-07-08 |
| EPT-1000 XP CARDIAC ABLATION SYSTEM (P020025/S005) | Boston Scientific | 2004-07-07 |
| LEAD ADAPTERS MODEL 6833, 6836, 6931 (P830060/S055) | Boston Scientific | 2004-07-06 |
| LEAD ADAPTERS, MODEL NUMBERS 6833, 6836, AND 6931 (P910073/S046) | Boston Scientific | 2004-07-06 |
| NIRFLEX PREMOUNTED CORONARY STENT SYSTEM (P020040/S001) | Medinol, Ltd. | 2004-07-02 |
| CARBOMEDICS PROSTHETIC HEART VALVE (CPHV) (P900060/S029) | Corcym S.r.l. | 2004-07-02 |
| QUICKSEAL SURESTAT ARTERIAL CLOSURE SYSTEM (P010049/S011) | Sub-Q, Inc. | 2004-07-01 |
| ST JUDE MEDICAL EPIC HF SYSTEM (P030054) | ABBOTT MEDICAL | 2004-06-30 |
| ANGIOJET RHEDOLYTIC THROMBECTOMY SYSTEM CORONARY USE (P980037/S011) | Boston Scientific Corp | 2004-06-30 |
| HEARTMATE XVE LVAS (P920014/S019) | Thoratec Corp | 2004-06-29 |
| CONTAK RENEWAL TR (MODEL H120 AND H125) (P030005/S002) | Guidant Corp. | 2004-06-28 |
| ABIOMED BVS5000 BI-VENTRICULAR SUPPORT SYSTEM AND AB5000 CIRCULATORY SUPPORT SYSTEM (P900023/S040) | Abiomed Cardiovascular, Inc. | 2004-06-28 |
| ABIOMED BVS5000 BI-VENTRICULAR SUPPORT SYSTEM AND AB5000 CIRCULATORY SUPPORT SYSTEM (P900023/S041) | Abiomed Cardiovascular, Inc. | 2004-06-28 |
| INTRINSIC 30 DUAL CHAMBER INPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM (P980016/S041) | Medtronic Cardiac Rhythm Disease Management | 2004-06-25 |
| INSYNC II PROTECT MODEL 7295 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM (P010031/S014) | Medtronic Cardiac Rhythm Disease Management | 2004-06-24 |
| SPRINTER OVER-THE-WIRE (OTW) BALLOON DILATATION CATHETER (MULTIPLE MODEL NUMBERS FOR THE 1.5 MM TO 4.0 MM DIAMETERS) (P790017/S081) | Medtronic, Ireland | 2004-06-23 |
| MODEL 7303 INSYNC MAXIMO DUAL CHAMBER ICD SYSTEM AND MODEL 9998 APPLICATION SOFTWARE VERSION 1.0 FOR THE MODEL 2090 PROG (P010031/S013) | Medtronic Cardiac Rhythm Disease Management | 2004-06-23 |
| ANGIOJET PHEOLYTIC THROMBECTOMY SYSTEM (P980037/S010) | Boston Scientific Corp | 2004-06-22 |
| THE BELOS, TACHOS ATX, AND LEXOS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR FAMILIES AND CARDIAC AIRBAG (P000009/S012) | Biotronik, Inc. | 2004-06-22 |
| ANGIOJET RHEOLYTIC THROMBECTOMY CATHETER SYSTEM (P980037/S009) | Boston Scientific Corp | 2004-06-22 |
| ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S081) | Boston Scientific Corp | 2004-06-18 |
| VOYAGER RX CORONARY DILATATION CATHETER (P810046/S216) | Advanced Cardiovascular Systems, Inc. | 2004-06-18 |
| STELID II/STELIX/STELIX II ENDOCARDIAL PACING LEAD (P020030) | MicroPort CRM USA, Inc. | 2004-06-17 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S008) | Cordis Corp. | 2004-06-14 |
| NOVOSTE BETA-CATH 3.5F SYSTEM (P000018/S040) | Best Vascular, Inc. | 2004-06-10 |
| GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM (P000052/S025) | Guidant Corp. | 2004-06-10 |
| 7F FREEZOR CARDIAC CRYOABLATION CATHETER AND CCT.2 CRYOCONSOLE SYSTEM (P020045/S005) | Medtronic Cryocath, LP | 2004-06-10 |
| MAVERICK MONORAIL PTCA CATHETER SYSTEM AND MAVERICK2 MONORAIL PTCA CATHETER SYSTEM (P860019/S200) | Scimed Life Systems, Inc. | 2004-06-10 |
| EPT-1000 XP CARDIAC ABLATION SYSTEM (P020025/S004) | Boston Scientific | 2004-06-09 |
| CAPUSRE SP/SENSE SP NOVUS (P830061/S037) | Medtronic Cardiac Rhythm Disease Management | 2004-06-08 |
| CAPSURE SP NOVUS Z NOVUS (P850089/S053) | Medtronic Cardiac Rhythm Disease Management | 2004-06-08 |
| MODEL 6948 AND 6930 LEADS (P920015/S030) | Medtronic, Inc. | 2004-06-08 |
| MEDTRONIC CAPSUREFIX NOVUS (P930039/S019) | Medtronic, Inc. | 2004-06-08 |
| INTRASTENT DOUBLESTRUT STENT (P030045) | Medtronic Vascular, Inc. | 2004-06-08 |
| MODEL 6949 AND 6931 LEADS (P920015/S029) | Medtronic, Inc. | 2004-06-08 |
| AT500 DDDRP PACING SYSTEM (P980035/S037) | Medtronic, Inc. | 2004-06-07 |
| EXCLUDER BIFURCATED ENDOPROTHESIS (P020004/S006) | W. L. Gore & Associates, Inc. | 2004-06-02 |
| MEDTRONIC INSYNC ICD MODEL 7272 AND MODEL 9969 APPLICATION SOFTWARE (P010031/S012) | Medtronic Cardiac Rhythm Disease Management | 2004-05-28 |
| QUICKSEAL SURESHOT ARTERIAL CLOSURE SYSTEM (P010049/S010) | Sub-Q, Inc. | 2004-05-25 |
| CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIKLOAD (P000049/S014) | Nmt Medical, Inc. | 2004-05-21 |
| BLAZER RPM CARDIAC ABLATION CATHETERS (P920047/S023) | Boston Scientific Corp | 2004-05-18 |
| VENTAK AV, VENTAK VR, VENTAK PRIZMALITY, VITALITY 2 (P960040/S044) | Boston Scientific | 2004-05-14 |
| CONTAK CD, CONTAK CD 2, EASYTRAK, CONTAK RENEWAL, CONTAK RENEWAL 3 (P010012/S027) | Boston Scientific Corp | 2004-05-14 |
| EXPRESS 2 CORONARY STENT SYSTEM (P020009/S016) | Boston Scientific Scimed, Inc. | 2004-05-14 |
| ENDOTAK, ENDOTAK ENDURANCE, ENDOTAK RELIANCE (P910073/S045) | Boston Scientific | 2004-05-14 |
| CARDIOSEAL SEPTAL OCCLUSION SYSTEM (P000049/S013) | Nmt Medical, Inc. | 2004-05-14 |
| VENTAK PRX,VENTAK MINI (P910077/S045) | Boston Scientific | 2004-05-14 |
| VIGOR, DISCOVERY, MERIDIAN (P940031/S031) | Boston Scientific | 2004-05-14 |
| SWEET TIP RX,SWEET PICOTIP RX,FLEXTEND (P960006/S010) | Boston Scientific | 2004-05-14 |
| TAXUS EXPRESS 2 CORONARY STENT SYSTEM (P030025/S003) | Boston Scientific Corp | 2004-05-14 |
| VENTAK P (P890061/S014) | Boston Scientific | 2004-05-14 |
| FINELINE,FINELINE II (P960004/S025) | Boston Scientific | 2004-05-14 |
| SELUTE,SELUTE PICOTIP (P950001/S011) | Boston Scientific | 2004-05-14 |
| VENTAK P2,VENTAK P3 (P930035/S012) | Boston Scientific | 2004-05-14 |
| VENTAK BIPOLAR ENDOCARDIAL LEADS (P830060/S054) | Boston Scientific | 2004-05-14 |
| ANTHEM AND FRONTIER II CRT-P'S (P030035) | ABBOTT MEDICAL | 2004-05-13 |
| HOUSECALL PLUS TRANSTELEPHONIC MONITORING SYSTEM WITH MODEL 3180-T TRANSMITTER AND MODEL 3180-R RECEIVER SOFTWARE (VERS (P910023/S073) | ABBOTT MEDICAL | 2004-05-12 |
| CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIKLOAD (P000049/S012) | Nmt Medical, Inc. | 2004-05-10 |
| WALLSTENT (TIPS AND VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P980033/S010) | Boston Scientific Corporation | 2004-05-07 |
| WALLSTENT (TIPS AND VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P930031/S021) | Boston Scientific Corp | 2004-05-07 |
| TAXUS EXPRESS2 MONORAIL AND OVER-THE-WIRE CORONARY STENT SYSTEMS (P030025/S002) | Boston Scientific Corp | 2004-05-05 |
| POSSIS ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM (P980037/S007) | Boston Scientific Corp | 2004-05-05 |
| EXPRESS2 MONORAIL AND OVER-THE-WIRE CORONARY STENT SYSTEMS (P020009/S015) | Boston Scientific Scimed, Inc. | 2004-05-05 |
| VITALITY 2 SYSTEM GUIDE (P960040/S043) | Boston Scientific | 2004-05-04 |
| GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM (P000052/S024) | Guidant Corp. | 2004-05-04 |
| ORCHESTRA PROGRAMMER (P980049/S015) | MicroPort CRM USA, Inc. | 2004-05-04 |
| LIFEVEST (WCD 3000S) WEARABLE DEFIBRILLATOR (P010030/S005) | Zoll Manufacturing Corporation | 2004-05-03 |