| VITALITY DEVICES & VENTAK PRISM DEVICES (P960040/S052) | Boston Scientific | 2005-04-08 |
| CARBOMEDICS PROSTETIC HEART VALVE (CPHV) (P900060/S030) | Corcym S.r.l. | 2005-04-08 |
| CARPENTIER-EDWARDS SUPRAANNULAR (S.A.V.) BIOPROSTHESIS, MODEL 2650 (P010041/S007) | Edwards Lifesciences, LLC | 2005-04-08 |
| EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS MODEL 2500P (P000007/S007) | Edwards Lifesciences, LLC | 2005-04-08 |
| MEDTRONIC INSYNC III MARQUIS,MAXIMO & SENTRY (P010031/S018) | Medtronic Cardiac Rhythm Disease Management | 2005-04-08 |
| CARPENTIER-EDWARDS BIOPROSTHESIS MODELS 2625,6625, VALVED CONDUIT MODEL 4300 (P870056/S020) | Edwards Lifesciences, LLC | 2005-04-08 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS MODELS 2700TFX, 2800TFX, 3000TFX, AND 6900PTX (P860057/S023) | Edwards Lifesciences, LLC | 2005-04-07 |
| PRE-MOLDED HEADER CONNECTOR DESIGN FOR THE INTEGRITY DR MODEL 5336, IDENTITY DR MODEL 5370, IDENTITY ADX DR MODEL 5380, (P880086/S103) | ABBOTT MEDICAL | 2005-04-06 |
| TAXUS EXPRESS CORONARY STENT SYSTEM (P030025/S005) | Boston Scientific Corp | 2005-03-31 |
| INTRINSIC 30 MODEL 7287 AND INTRINSIC MODEL 7288 IMPLANTABLE DEVICES (P010031/S019) | Medtronic Cardiac Rhythm Disease Management | 2005-03-31 |
| MEDTRONIC MODELS 2490G AND 2490J CARELINK MONITORS AND MODEL 2491 DDMA SOFTWARE (P890003/S081) | Medtronic, Inc. | 2005-03-31 |
| INSYNC MAXIMO MODEL 7303 ONYX VR (P980016/S047) | Medtronic Cardiac Rhythm Disease Management | 2005-03-31 |
| EPIC, EPIC+, AND EPIC HE ICD SYSTEMS (P030054/S006) | ABBOTT MEDICAL | 2005-03-30 |
| 7F FREEZOR CARDIAC CRYOABLATION CATHETER & CCT.2 CRYOCONSOLE SYSTEM (P020045/S007) | Medtronic Cryocath, LP | 2005-03-29 |
| ENDOTAK FAMILY INCLUDES ENDOTAK, ENDOTAK ENDURANCE, ENDOTAK RELIANCE (P910073/S050) | Boston Scientific | 2005-03-24 |
| FINELINE FAMILY INCLUDES FINELINE, FINELINE II (P960004/S028) | Boston Scientific | 2005-03-24 |
| EASYTRAK FAMILY INCLUDES EASYTRAK, EASYTRAK 2, EASYTRAK 3 (P010012/S043) | Boston Scientific Corp | 2005-03-24 |
| SELUTE FAMILY (INCLUDES SELUTE, SELUTE PICOTIP) (P950001/S014) | Boston Scientific | 2005-03-24 |
| SWEET TIP RX FAMILY INCLUDING SWEET TIP RX, SWEET PICOTIP RX FLEXTEND FAMILY (P960006/S014) | Boston Scientific | 2005-03-24 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043) | W. L. Gore & Associates, Inc. | 2005-03-23 |
| ABIOMED AB5000 CIRCULATORY SUPPORT SYSTEM (P900023/S042) | Abiomed Cardiovascular, Inc. | 2005-03-23 |
| HEARTMATE LVAS SYSTEM (P920014/S025) | Thoratec Corp | 2005-03-22 |
| THORATEC VENTRICULAR ASSIST DEVICE(VAD) SYSTEM (P870072/S033) | Thoratec Laboratories Corp. | 2005-03-22 |
| STOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR (P990071/S006) | Biosense Webster, Inc. | 2005-03-21 |
| THE HEART LASER CO2 TMR SYSTEM (P950015/S010) | Laser Engineering Heart, Inc. | 2005-03-21 |
| VITATRON C60 DR (MODEL C60A3) AND VITATRON C20 SR (MODEL C20A3) IMPLANTABLE PULSE GENERATORS AND THEIR ASSOCIATED SOFTWA (P990001/S017) | Medtronic, Inc. | 2005-03-16 |
| ULTRA2 CUTTING BALLOON MONORAIL(MR) (P950020/S012) | Boston Scientific Corp | 2005-03-16 |
| ABIOMED BVS5000 BI-VENTRICULAR SUPPORT SYSTEM AND AB5000 CIRCULATORY SUPPORT SYSTEM (P900023/S043) | Abiomed Cardiovascular, Inc. | 2005-03-11 |
| TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL, MR AND OVER-THE-WIRE, OTW) (P030025/S010) | Boston Scientific Corp | 2005-03-09 |
| EXPRESS/EXPRESS2 CORONARY STENT SYSTEM (MONORAIL, MR AND OVER-THE-WIRE, OTW) (P020009/S017) | Boston Scientific Scimed, Inc. | 2005-03-09 |
| CUTTING BALLOON MONORAIL(MR)/OVER THE WIRE(OTW) (P950020/S011) | Boston Scientific Corp | 2005-03-08 |
| EPIC HF & ATLAS + HF CRT-D SYSTEMS (P030054/S005) | ABBOTT MEDICAL | 2005-03-08 |
| SYCHRONY PULSE GENERATOR (P880086/S102) | ABBOTT MEDICAL | 2005-03-08 |
| GUIDANT CONTAK RENEWAL TR MODELS H125 AND H120 (P030005/S005) | Guidant Corp. | 2005-03-08 |
| NC STORMER MX2/OTW BALLOON DILATATION CATHETER (P790017/S082) | Medtronic, Ireland | 2005-03-04 |
| HEART FAILURE PARTNER MODEL 2936 WITH SOFTWARE VERSION 1.1 (P910077/S048) | Boston Scientific | 2005-03-02 |
| EPIC AND EPIC+ DR/VR ICD SYSTEMS WITH N2 CAPACITOR (P910023/S076) | ABBOTT MEDICAL | 2005-03-01 |
| VITALITY HE MODEL T182 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM AND THE CONSULT PROGRAMMER SOFTWARE APPLICAT (P960040/S051) | Boston Scientific | 2005-03-01 |
| CHILLI II COOLED ABLATION CATHETER (P980003/S014) | Boston Scientific Corp | 2005-03-01 |
| CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPRSTHESIS, MODEL 6625LP AND 6625-ESR-LP (P870077/S017) | Edwards Lifesciences, LLC | 2005-02-28 |
| CARPENTIER-EDWARDS BIOPROSTHESIS, MODEL 2625, 6625 AND VALVED CONDUIT MODEL 4300 (P870056/S019) | Edwards Lifesciences, LLC | 2005-02-28 |
| ELA MEDICAL RATE-RESPONSIVE PACEMAKERS (P950029/S023) | MicroPort CRM USA, Inc. | 2005-02-28 |
| ELA MEDICAL IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P980049/S018) | MicroPort CRM USA, Inc. | 2005-02-28 |
| EPT-1000 XP CARDIAC ABLATION SYSTEM (P020025/S010) | Boston Scientific | 2005-02-28 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS MODELS 2700, 2700TFX 2800TFX (P860057/S026) | Edwards Lifesciences, LLC | 2005-02-28 |
| EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS MODEL 2500P (P000007/S006) | Edwards Lifesciences, LLC | 2005-02-28 |
| BLAZER II AND BLAZER II XP CARDIAC ABLATION CATHETERS (P920047/S026) | Boston Scientific Corp | 2005-02-28 |
| CARPENTIER-SUPRAANNULAR (S.A.V.) BIOPROSTHESIS MODEL 2650 (P010041/S006) | Edwards Lifesciences, LLC | 2005-02-28 |
| PROGRAMMER SOFTWARE APPLICATION MODEL 2812 VERSION 1.3 (P960040/S049) | Boston Scientific | 2005-02-18 |
| MEDTRONIC MODEL 2090 CARELINK PROGRAMMER WITH TELEMETRY C (P890003/S080) | Medtronic, Inc. | 2005-02-18 |
| ENDOLOGIX POWERLINK SYSTEM (P040002/S001) | Endologix, LLC | 2005-02-15 |
| CARELINK MONITOR MODELS 2490G, 2490H AND 2490J (P890003/S079) | Medtronic, Inc. | 2005-02-15 |
| EXPRESS, EXPRESS2 CORONARY STENT SYSTEM (MOMORAIL AND OVER-THE-WIRE) (P020009/S019) | Boston Scientific Scimed, Inc. | 2005-02-15 |
| TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE) (P030025/S014) | Boston Scientific Corp | 2005-02-15 |
| PTCA BALLOON CATHETERS, EXPRESS2 CORONARY STENT SYSTEM AND TAXUS EXPRESS2 (P860019/S202) | Scimed Life Systems, Inc. | 2005-02-15 |
| LIFEVEST (WCD 300) DEVICE WITH APPLICATION SOFTWARE VERSION 4.0 (P010030/S006) | Zoll Manufacturing Corporation | 2005-02-15 |
| PTCA BALLOON CATHETERS, EXPRESS2 CORONARY STENT SYSTEM AND TAXUS EXPRESS2 (P030025/S015) | Boston Scientific Corp | 2005-02-15 |
| PTCA BALLOON CATHETERS, EXPRESS2 CORONARY STENT SYSTEM AND TAXUS EXPRESS2 (P020009/S020) | Boston Scientific Scimed, Inc. | 2005-02-15 |
| SJM MASTERS SERIES AORTIC VALVED PROSTHESIS WITH VASCUTEK GELWEAVE VALSALVA GRAFT (MODEL VAVGJ-515) (P810002/S058) | ABBOTT MEDICAL | 2005-02-14 |
| CONTAK RENEWAL 3, MODELS H170, H175, H177 AND H179 (P010012/S041) | Boston Scientific Corp | 2005-02-11 |
| MODEL 3120 ZOOM LATITUDE PROGRAMMING SYSTEM (P910077/S046) | Boston Scientific | 2005-02-10 |
| ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S082) | Boston Scientific Corp | 2005-02-09 |
| CONTAK RENEWAL 3 RF/HE CRT-D,CONSULT PROGRAMMER SOFT WARE (P010012/S031) | Boston Scientific Corp | 2005-02-09 |
| ANGIOJET RHEOLYTIC THROMBECTOMY CATHETER SYSTEM (P980037/S012) | Boston Scientific Corp | 2005-02-04 |
| TAPCATH AND TAPSCOPE DISPOSABLE TRANSESOPHAGEAL PROBES (P860008/S017) | Cardio Command | 2005-02-03 |
| TAPCATH AND TAPSCOPE DISPOSABLE TRANSESOPHAGEAL PROBES (P840002/S010) | Cardiocommand, Inc. | 2005-02-03 |
| CONTAK RENEWAL CRT-D MODEL H125 (P010012/S042) | Boston Scientific Corp | 2005-02-02 |
| THORATEC HEARTMATE XVE AND VE LEFT VENTRICULAR ASSIST SYSTEM (LVAS) (P920014/S024) | Thoratec Corp | 2005-02-02 |
| CARPENTIER-EDWARDS BIOPROSTHESIS, MODELS 2625 AND 6625 (P870056/S018) | Edwards Lifesciences, LLC | 2005-01-19 |
| EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS MODEL 2500P (P000007/S005) | Edwards Lifesciences, LLC | 2005-01-19 |
| CARPENTIER-SUPRANNULAR BIOPROSTHESIS MODEL 2650 (P010041/S005) | Edwards Lifesciences, LLC | 2005-01-19 |
| CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPROSTHESIS, MODELS 6625L AND 6625-ESR-LP (P870077/S016) | Edwards Lifesciences, LLC | 2005-01-19 |
| PERIMOUNT PERICARDIAL BIOPROSTHESIS MODELS 2700,2700TFX,2800,2800TFX,3000,3000TFX,6900P PERIMOUNT PLUS AND 6900PTFX (P860057/S025) | Edwards Lifesciences, LLC | 2005-01-19 |
| CADENCE TIERED-THERAPY DEFIBRILLATOR SYSTEM (P910023/S075) | ABBOTT MEDICAL | 2005-01-19 |
| THORATEC IMPLANTABLE VENTRICULAR ASSIST DEVICE (IVAD) (P870072/S030) | Thoratec Laboratories Corp. | 2005-01-19 |
| WALLSTENT (ILIAC, TIPS, VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P940019/S018) | Boston Scientific Scimed, Inc. | 2005-01-14 |
| FRONTIER BIVENTRICULAR CARDIAC PACING SYSTEM (P030035/S002) | ABBOTT MEDICAL | 2005-01-14 |
| CROSSSAIL, OPENSAIL, RX CHASSIS I & III AND VOYAGER CORONARY DILATATION CATHETERS (P810046/S218) | Advanced Cardiovascular Systems, Inc. | 2005-01-14 |
| WALLSTENT (ILIAC, TIPS, VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P980033/S012) | Boston Scientific Corporation | 2005-01-14 |
| ST JUDE MEDICAL EPIC HF MODEL V-338 AND ATLAS + HF MODEL V-340 CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-DS) (P030054/S002) | ABBOTT MEDICAL | 2005-01-14 |
| IBI THERAPY CARDIAC ABLATION SYSTEM ERS/ 1500T RF GENERATOR (P040014) | Irvine Biomedical, Inc. | 2005-01-14 |
| WALLSTENT (ILIAC, TIPS, VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P930031/S023) | Boston Scientific Corp | 2005-01-14 |
| FLEXI-CUT DIRECTIONAL DEBULKING SYSTEM (P890043/S038) | Abbott Vascular | 2005-01-14 |
| BLAZER II XP CARDIAC ABLATION CATHETERS (P020025/S008) | Boston Scientific | 2005-01-10 |
| BLAZER II CARDIAC ABLATION CATHETERS (P920047/S025) | Boston Scientific Corp | 2005-01-10 |
| EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS MODEL 2500P (P000007/S004) | Edwards Lifesciences, LLC | 2004-12-29 |
| CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPROSTHESIS MODELS 6625LP AND 6625-ESR-LP (P870077/S015) | Edwards Lifesciences, LLC | 2004-12-29 |
| CARPENTIER-EDWARDS SUPRAANNULAR (S.A.V.) BIOPROSTHESIS MODEL 2650 (P010041/S004) | Edwards Lifesciences, LLC | 2004-12-29 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROTHESIS, MODELS 2700, 2700TFX, 2800,2800TFX, 3000, 3000TFX,6900P (PERI... (P860057/S024) | Edwards Lifesciences, LLC | 2004-12-29 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S001) | W. L. Gore & Associates, Inc. | 2004-12-29 |
| CARPENTIER-EDWARDS BIOPROSTHESIS, MODELS 2625 AND 6625 AND VALVED CONDUIT MODEL 4300 (P870056/S017) | Edwards Lifesciences, LLC | 2004-12-29 |
| SOLARGEN 2100S LASER (P970029/S009) | Cryolife, Inc. | 2004-12-23 |
| INTERTACH (P860007/S023) | Boston Scientific | 2004-12-22 |
| CONTAK CD, CONTAK CD2, EASYTRAK, EASYTRAK 2, EASYTRAK 3, CONTAK RENEWAL, CONTAK RENEWAL 3 (P010012/S040) | Boston Scientific Corp | 2004-12-22 |
| SWEET TIP RX,SWEET PICOTIP RX,FLEXTEND (P960006/S013) | Boston Scientific | 2004-12-22 |
| VENTAK PRX, VENTAK MINI (P910077/S049) | Boston Scientific | 2004-12-22 |
| CONTAK RENEWAL TR (P030005/S006) | Guidant Corp. | 2004-12-22 |
| DELTA, VISTA (P840068/S043) | Boston Scientific | 2004-12-22 |
| VIGOR, DISCOVERY, MERIDIAN (P940031/S033) | Boston Scientific | 2004-12-22 |
| ENDOTAK, ENDOTAK ENDURANCE, ENDOTAK RELIANCE (P910073/S049) | Boston Scientific | 2004-12-22 |