| FLEXTOME CUTTING BALLOON MONORAIL(MR)/OVER THE WIRE(OTW) (P950020/S010) | Boston Scientific Corp | 2005-07-18 |
| STOCKERT 70 RADIOFREQUENCY GENERATOR FOR CARDIAC ABLATION (P990071/S007) | Biosense Webster, Inc. | 2005-07-12 |
| DISCOVERY/MERIDIAN (P940031/S038) | Boston Scientific | 2005-07-11 |
| ON-X PROSTHETIC HEART VALVE (P000037/S006) | On-X Life Technologies, Inc. | 2005-07-11 |
| PULSE GENERATOR (P880086/S104) | ABBOTT MEDICAL | 2005-07-08 |
| CONTAK RENEWAL TR (P030005/S010) | Guidant Corp. | 2005-07-08 |
| VENTAK MINI (P910077/S052) | Boston Scientific | 2005-07-08 |
| RELIANCE TRANSVENOUS ENDOCARDIAL DEFIBRILLATION LEAD (P910073/S051) | Boston Scientific | 2005-07-08 |
| CONTAK CD, CONTAK RENEWAL, EASYTRAK (P010012/S052) | Boston Scientific Corp | 2005-07-08 |
| PRIZM, VENTAK AV, VENTAK VR, VITALITY (P960040/S063) | Boston Scientific | 2005-07-08 |
| TAXUS EXPRESS PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S017) | Boston Scientific Corp | 2005-07-08 |
| DISCOVERY, MERIDIAN (P940031/S036) | Boston Scientific | 2005-07-08 |
| CONTRK RENEWAL (P010012/S048) | Boston Scientific Corp | 2005-07-07 |
| PRIZM, PRIZM 2, PRIZM HE, VITALITY, VITALITY AVT, VITALITY DS, VITALITY 2 (P960040/S056) | Boston Scientific | 2005-07-07 |
| INTRACOIL SELF-EXPANDING PERIPHERAL STENT (P000033/S002) | Medtronic Vascular, Inc. | 2005-07-07 |
| TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL, MR AND OVER-THE-WIRE, OTW) (P030025/S020) | Boston Scientific Corp | 2005-06-29 |
| ISOFLEX S PERMANENT PACING LEAD MODELS PASSIVE PLUS DX (P960030/S011) | ABBOTT MEDICAL | 2005-06-29 |
| 7F FREEZOR CARDIAC CRYOABLATION CATHETER & CCT.2 CRYOCONSOLE SYSTEM (P020045/S009) | Medtronic Cryocath, LP | 2005-06-27 |
| 7F FREEZOR CARDIAC CRYOABLATION CATHETER & CCT.2 CRYOCONSOLE SYSTEM (P020045/S008) | Medtronic Cryocath, LP | 2005-06-24 |
| MEDTRONIC VASCULAR ANEURX STENT GRAFT WITH XCELERANT DELIVERY SYSTEM (P990020/S019) | Medtronic Vascular | 2005-06-24 |
| SPRINTER MX2 BALLOON DILATATION CATHETER (P790017/S083) | Medtronic, Ireland | 2005-06-22 |
| PROTOS DR/CLS AND PROTOS VR/CLS (P950037/S039) | Biotronik, Inc. | 2005-06-22 |
| BELOS, CARDIAC AIRBAG, LEXOS, AND XELOS FAMILIES OF ICDS (P000009/S015) | Biotronik, Inc. | 2005-06-22 |
| AT500 DDDRP PACING SYSTEM (MODEL AT500) AND MODEL 9968 SOFTWARE POST-MARKET (RESPECT): ADDING THE ENRHYTHM MODEL P1501DR (P980035/S041) | Medtronic, Inc. | 2005-06-20 |
| GUIDANT PULSE GENERATORS (P830060/S058) | Boston Scientific | 2005-06-20 |
| ANEURX STENT GRAFT WITH XCELERANT DELIVERY SYSTEM (P990020/S018) | Medtronic Vascular | 2005-06-17 |
| BLAZER II/BLAZER II XP CARDIAC ABLATION CATHETERS (P020025/S011) | Boston Scientific | 2005-06-17 |
| ATLAS AND ATLAS+ IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P030054/S007) | ABBOTT MEDICAL | 2005-06-17 |
| ICD FIRMWARE VERSION 6.6.7 FOR EPIC, EPIC +, ATLAS AND ATLAS +, AND MODEL 3307 PROGRAMMER SOFTWARE VERSION 4.8.5 (P910023/S077) | ABBOTT MEDICAL | 2005-06-17 |
| BLAZER II AND BLAZER II XP CARDIAC ABLATION CATHETERS (P920047/S027) | Boston Scientific Corp | 2005-06-17 |
| STINGER, STINGER S, STINGER M, & STINGER SM ABLATION CATHETER (P000020/S009) | Boston Scientific Corp | 2005-06-16 |
| MEDTRONIC ENTRUST MODELS D153ATG, D153DRG, D153VRC, D154ATG, D154DRG, D154VRC, MEDTRONIC MODEL 9987 APPLICATION SOFTWAR (P980016/S046) | Medtronic Cardiac Rhythm Disease Management | 2005-06-14 |
| GORE EXCLUDER BIFURCATED ENDOPROSTHESIS (P020004/S013) | W. L. Gore & Associates, Inc. | 2005-06-14 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S005) | W. L. Gore & Associates, Inc. | 2005-06-14 |
| CONTAK RENEWAL CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (P010012/S047) | Boston Scientific Corp | 2005-06-14 |
| VIABAHN ENDOPROSTHESIS (P040037) | W. L. Gore & Associates, Inc. | 2005-06-14 |
| ZENITH AAA ENDOVASCULAR GRAFT (P020018/S006) | Cook, Inc. | 2005-06-14 |
| VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (P960040/S055) | Boston Scientific | 2005-06-14 |
| ZENITH FLEX AAA ENDOVASCULAR GRAFT WITH THE H&LB ONE-SHOT INTRODUCTION SYSTEM (P020018/S005) | Cook, Inc. | 2005-06-09 |
| MEDTRONIC 2030A BATTERYCHECK MONITOR TO BE USED WITH THE INSYNC II MARQUIS 7289, INSYNC MARQUIS MODEL 7277, MAXIMO DR... (P980016/S051) | Medtronic Cardiac Rhythm Disease Management | 2005-06-08 |
| EDTRONIC 2030A BATTERYCHECK MONITOR (P890003/S085) | Medtronic, Inc. | 2005-06-08 |
| MEDTRONIC 2030A BATTERYCHECK MONITOR TO BE USED WITH THE INSYNC II MARQUIS 7289, INSYNC MARQUIS MODEL 7277, MAXIMO DR... (P010031/S023) | Medtronic Cardiac Rhythm Disease Management | 2005-06-08 |
| EXPRESS2 CORONARY STENT SYSTEM (P020009/S022) | Boston Scientific Scimed, Inc. | 2005-06-07 |
| LIBERTE CORONARY STENT SYSTEM (P040016/S001) | Boston Scientific Scimed, Inc. | 2005-06-07 |
| TAXUS EXPRESS PACLITAXEL ELUTING CORONARY STENT SYSTEM (P030025/S019) | Boston Scientific Corp | 2005-06-07 |
| GORE EXCLUDER BIFURCATED ENDOPROSTHESIS (P020004/S012) | W. L. Gore & Associates, Inc. | 2005-06-07 |
| STOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR (P990071/S005) | Biosense Webster, Inc. | 2005-06-06 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT ON THE RAPTOR OVER-THE WIRE DELIVERY (P020026/S013) | Cordis Corp. | 2005-06-06 |
| RIATA ST LEAD MODELS 7000, 7001, AND 7002 (P950022/S024) | ABBOTT MEDICAL | 2005-06-03 |
| ON-X PROSTHETIC HEART VALVE (P000037/S005) | On-X Life Technologies, Inc. | 2005-06-03 |
| CONSULT PROGRAMMER SOFTWARE APPLICATION MODEL 2896 VERSION 2.0 (P960040/S054) | Boston Scientific | 2005-06-03 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S011) | Cordis Corp. | 2005-05-29 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S004) | W. L. Gore & Associates, Inc. | 2005-05-27 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S003) | W. L. Gore & Associates, Inc. | 2005-05-27 |
| ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S084) | Boston Scientific Corp | 2005-05-25 |
| HOUSECALL PLUS TRANSTELEPHONIC MONITORING SYSTEM WITH MODEL 3180-R RECEIVER SOFTWARE (VERSION 2.1) (P910023/S078) | ABBOTT MEDICAL | 2005-05-24 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS, MODELS 2700, 2700TFX, 2800, 2800TFX, 2900, 3000, 3000TFX, 6900,X (P860057/S028) | Edwards Lifesciences, LLC | 2005-05-20 |
| EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS MODEL 2500, 2500P (P000007/S008) | Edwards Lifesciences, LLC | 2005-05-20 |
| CHILLI II COOLED ABLATION CATHETER (P980003/S015) | Boston Scientific Corp | 2005-05-20 |
| CARPENTIER-EDWARDS SUPRANNULAR (S.A.V.) BIOPROSTHESIS, MODEL 2650,6650 (P010041/S008) | Edwards Lifesciences, LLC | 2005-05-20 |
| CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPROSTHESIS MODELS 6625LP AND 6625-ESR-LP (P870077/S019) | Edwards Lifesciences, LLC | 2005-05-20 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S002) | W. L. Gore & Associates, Inc. | 2005-05-20 |
| CARPENTIER-EDWARDS BIOPRSOTHESIS, MODEL 2625,6625 (P870056/S021) | Edwards Lifesciences, LLC | 2005-05-20 |
| VASOSEAL ON-SITE PRECISION CLOSURE DEVICE (P920004/S020) | St. Jude Medical, Inc. | 2005-05-19 |
| TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S007) | Boston Scientific Corp | 2005-05-19 |
| IMPLANT CONTROL SYSTEM (ICS) 3000 (P950037/S035) | Biotronik, Inc. | 2005-05-18 |
| VITALITY HE MODEL T180 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM AND THE CONSULT PROGRAMMER SOFTWARE APPLICAT (P960040/S053) | Boston Scientific | 2005-05-18 |
| RIATA DEFIBRILLATION LEADS (P950022/S019) | ABBOTT MEDICAL | 2005-05-16 |
| ANGIO-SEAL VASCULAR CLOSURE DEVICE (P930038/S042) | Terumo Medical Corporation | 2005-05-16 |
| ALTO SHOCK 4 MODULES (P980049/S019) | MicroPort CRM USA, Inc. | 2005-05-13 |
| ANGIO-SEAL VASCULAR CLOSURE DEVICE (P930038/S043) | Terumo Medical Corporation | 2005-05-12 |
| MAVERICK 2 MONORAIL AND MAVERICK OTW PTCA CATHETERS (P860019/S201) | Scimed Life Systems, Inc. | 2005-05-11 |
| EXCLUDER BIFURCATED ENDOPROSTHESIS (P020004/S010) | W. L. Gore & Associates, Inc. | 2005-05-10 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S001) | W. L. Gore & Associates, Inc. | 2005-05-10 |
| DUAL CHAMBER IMPLANTABLE CARDIOVERTER (P030054/S009) | ABBOTT MEDICAL | 2005-05-09 |
| CADENCE (R) TIERED THERAPY DEFIBRILLATOR SYSTEM (P910023/S079) | ABBOTT MEDICAL | 2005-05-09 |
| FLEXTEND LEADS, MODELS 4086, 4087, AND 4088 (P960006/S015) | Boston Scientific | 2005-05-06 |
| RIATA FAMILY OF DEFIBRILLATION LEADS (P950022/S022) | ABBOTT MEDICAL | 2005-05-05 |
| RIATA FAMILY OF DEFIBRILLATION LEADS (P950022/S021) | ABBOTT MEDICAL | 2005-05-05 |
| RIATA FAMILY OF DEFIBRILLATION LEADS (P950022/S020) | ABBOTT MEDICAL | 2005-05-05 |
| RIATA FAMILY OF DEFIBRILLATION LEADS (P950022/S023) | ABBOTT MEDICAL | 2005-05-05 |
| ON-X PROSTHETIC HEART VALVE (P000037/S004) | On-X Life Technologies, Inc. | 2005-05-04 |
| FRONTIER MODEL 5508L AND FRONTIER II MODEL 5586 CARDIAC RESYNCHRONIZATION THERAPY PACEMAKERS (P030035/S003) | ABBOTT MEDICAL | 2005-04-29 |
| RITHRON-XR CORONARY STENT SYSTEM (P030037) | Biotronik GmbH & Co. KG | 2005-04-29 |
| MEDTRONIC MODEL P1501DR ENRHYTHM IMPLANTABLE PULSE GENERATOR, MEDTRONIC MODEL 9987 APPLICATION SOFTWARE AND MEDTRONIC MO (P980035/S038) | Medtronic, Inc. | 2005-04-28 |
| XELOS DR-T ICD SYSTEM AND APPLICATION SOFTWARE VERSION A-K00.3.U (P000009/S014) | Biotronik, Inc. | 2005-04-28 |
| ISOFLEX P LEAD FAMILY MODELS 1644T AND 1648T STEROID ELUTING, PASSIVE FIXATION ENDOCARDIAL PACING LEADS (P960030/S012) | ABBOTT MEDICAL | 2005-04-27 |
| SYMPHONY DR 2550 MODE AND ELAVIEW 1.28 UG1 PROGRAMMING SOFTWARE (P950029/S022) | MicroPort CRM USA, Inc. | 2005-04-27 |
| VOYAGER RX CORONARY DILATATION CATHETER (P810046/S219) | Advanced Cardiovascular Systems, Inc. | 2005-04-26 |
| MULTI-LINK CORONARY STENT SYSTEMS (P970020/S046) | Abbott Vascular, Inc. | 2005-04-21 |
| CORDIS CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S010) | Cordis Corp. | 2005-04-15 |
| RENEWAL PULSE GENERATORS (P010012/S046) | Boston Scientific Corp | 2005-04-14 |
| TAXUS EXPRESS PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S018) | Boston Scientific Corp | 2005-04-13 |
| VERIFLEX (LIBERTE) BARE-METAL CORONARY STENT SYSTEM (P040016) | Boston Scientific Scimed, Inc. | 2005-04-12 |
| QUICKSITE 1056T LEFT VENTRICULAR PACING LEAD (P030054/S004) | ABBOTT MEDICAL | 2005-04-11 |
| CONTAK CD2, CONTAK RENEWAL/RENEWAL 3/ RENEWAL 3/3HE RF (P010012/S045) | Boston Scientific Corp | 2005-04-08 |
| DISCOVERY & MERIDIAN DEVICE (P940031/S034) | Boston Scientific | 2005-04-08 |
| CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPRSOTHESIS MODELS 6625LP AND 6625-ESR LP (P870077/S018) | Edwards Lifesciences, LLC | 2005-04-08 |
| CONTAK RENEWAL TR (P030005/S008) | Guidant Corp. | 2005-04-08 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS MODEL 2700, 2700TFX, 2800TFX, 3000, 3000TFX, 6900, 6900P PERIMOUN (P860057/S027) | Edwards Lifesciences, LLC | 2005-04-08 |