| CONTAK RENEWAL CARDIAC RESYNCHRONIZATION THERAPY (CRT) DEVICES (P010012/S084) | Boston Scientific Corp | 2005-12-20 |
| CONTAK RENEWAL CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER(CRT-P) DEVICES (P030005/S027) | Guidant Corp. | 2005-12-20 |
| CONTAK RENEWAL (P010012/S080) | Boston Scientific Corp | 2005-12-19 |
| DISCOVERY/MERIDIAN (P940031/S047) | Boston Scientific | 2005-12-19 |
| CONTAK RENEWAL TR (P030005/S024) | Guidant Corp. | 2005-12-19 |
| PRIZM/VITALITY (P960040/S089) | Boston Scientific | 2005-12-19 |
| BIOSENSE WEBSTER NAVISTAR/ CELSIUS THERMOCOOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS (P030031/S001) | Biosense Webster, Inc. | 2005-12-19 |
| CELSIUS RMT DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS, MODEL D-1249-02-S (P950005/S018) | Biosense Webster, Inc. | 2005-12-16 |
| ST.JUDE MEDICAL ICDS/CRT-DS (P030054/S011) | ABBOTT MEDICAL | 2005-12-16 |
| ST.JUDE MEDICAL ICDS/CRT-D (P910023/S080) | ABBOTT MEDICAL | 2005-12-16 |
| LIBERTE CORONARY STENT SYSTEM (P040016/S004) | Boston Scientific Scimed, Inc. | 2005-12-16 |
| PTCA CATHETERS (P860019/S205) | Scimed Life Systems, Inc. | 2005-12-15 |
| ENDOTAK RELIANCE FAMILY OF LEADS (P910073/S060) | Boston Scientific | 2005-12-15 |
| GUIDANT VITALITY (P960040/S090) | Boston Scientific | 2005-12-15 |
| FLEXTEND FAMILY OF LEADS (P960006/S019) | Boston Scientific | 2005-12-08 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S002) | W. L. Gore & Associates, Inc. | 2005-12-08 |
| BIOGLUE SURGICAL ADHESIVE (P010003/S007) | Cryolife, Inc. | 2005-12-08 |
| RELIANCE LEADS FLUORO RING (P910073/S059) | Boston Scientific | 2005-12-08 |
| IBI THERAPY ABLATION CATHETERS (P040014/S002) | Irvine Biomedical, Inc. | 2005-12-08 |
| VICTORY PULSE GENERATOR MODELS: XL DR 5816, DR 5810 AND SR 5610 (P880086/S108) | ABBOTT MEDICAL | 2005-12-07 |
| CARPENTIER-EDWARDS SUPRAANNULAR (S.A.V) BIOPROSTHESIS,MODEL 2650 (P010041/S010) | Edwards Lifesciences, LLC | 2005-12-06 |
| CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS (P870077/S021) | Edwards Lifesciences, LLC | 2005-12-06 |
| CARPENTIER-EDWARDS BIOPROSTHESIS,MODELS 2625 & 6625 (P870056/S023) | Edwards Lifesciences, LLC | 2005-12-06 |
| EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS, MODEL 2600P (P000007/S010) | Edwards Lifesciences, LLC | 2005-12-06 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P860057/S031) | Edwards Lifesciences, LLC | 2005-12-06 |
| RENEWAL 3 RF ICDS (P910077/S054) | Boston Scientific | 2005-12-02 |
| MEDTRONIC SPRINT FIDELIS LEADS MODELS,6949,6948,6931,6930 (P920015/S032) | Medtronic, Inc. | 2005-12-01 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S007) | W. L. Gore & Associates, Inc. | 2005-11-30 |
| PROSTHETIC HEART VALVE (CPHV), CARBO-SEAL ASCENDING AORTIC PROSTHESIS (AAP) AND CARBO-SEAL VALSALVA ASCENDING AORTIC PRO (P900060/S034) | Corcym S.r.l. | 2005-11-30 |
| AMPLATZER DUCT OCCLUDER (P020024/S009) | ABBOTT MEDICAL | 2005-11-30 |
| GORE EXCLUDER BIFURCATED ENDOPROSTHESIS (P020004/S014) | W. L. Gore & Associates, Inc. | 2005-11-30 |
| CONTAK RENEWAL TR (P030005/S023) | Guidant Corp. | 2005-11-30 |
| ST JUDES MEDICAL ICDS AND CRT-DS (P030054/S014) | ABBOTT MEDICAL | 2005-11-28 |
| ST JUDES MEDICAL ICD (P910023/S085) | ABBOTT MEDICAL | 2005-11-28 |
| CONTAK RENEWAL (P010012/S066) | Boston Scientific Corp | 2005-11-24 |
| PRIZM FAMILY (P960040/S075) | Boston Scientific | 2005-11-24 |
| RENEWAL 3 RF CRT-D, MODELS H210, H215, H217 AND H219 (P010012/S079) | Boston Scientific Corp | 2005-11-23 |
| RELIANCE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LEADS (P910073/S058) | Boston Scientific | 2005-11-23 |
| RX VOYAGER CORONARY DILATATION CATHETER (P810046/S217) | Advanced Cardiovascular Systems, Inc. | 2005-11-22 |
| MEDTRONIC REVEAL PLUS INSERTABLE LOOP RECORDER (ILR) APPLICATION SOFTWARE MODEL 9809 (P890003/S095) | Medtronic, Inc. | 2005-11-22 |
| VITATRON SOFTWARE MULTIPLE SOFTWARE MODELS (P990001/S020) | Medtronic, Inc. | 2005-11-22 |
| RELIANCE ACTIVE FIX, & PASSIVE FIX STEROID ELUTING ENDOCARDIAL DEFIBRILLATION LEAD (P910073/S057) | Boston Scientific | 2005-11-22 |
| 7F FREEZOR CARDIAC CRYOABLATION CATHETER & CCT.2 CRYOCONSOLE SYSTEM (P020045/S012) | Medtronic Cryocath, LP | 2005-11-18 |
| PHOTON, EPIC, AND ATLAS FAMILIES OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS) AND CARDIAC RESYNCHRONIZATION THERAPY (P910023/S087) | ABBOTT MEDICAL | 2005-11-18 |
| 7F FREEZOR CARDIAC CRYOABLATION CATHETER & CCT.2 CRYOCONSOLE SYSTEM (P020045/S011) | Medtronic Cryocath, LP | 2005-11-18 |
| PHOTON, EPIC, AND ATLAS FAMILIES OF ICDS AND CRT-DS (P030054/S017) | ABBOTT MEDICAL | 2005-11-18 |
| EPIC AND ATLAS+ HF CRT-D SYSTEMS (P030054/S010) | ABBOTT MEDICAL | 2005-11-18 |
| THERAPY DUAL 8 CARDIAC ABLATION SYSTEM,THERAM 8MM THERMISTER ABLATION CATHETER SAFIRE TX ABLATION CATHETER (P040042) | Irvine Biomedical,Inc.(Ibi) | 2005-11-18 |
| SELUTE AND SELUTE PICOTIP (P950001/S015) | Boston Scientific | 2005-11-15 |
| MEDTRONIC PACEMAKER SYSTEM (P890003/S091) | Medtronic, Inc. | 2005-11-15 |
| MEDTRONIC CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR SYSTEMS (P010031/S028) | Medtronic Cardiac Rhythm Disease Management | 2005-11-15 |
| MEDTRONIC MODEL 9996 AND MODEL 9997 (P980016/S055) | Medtronic Cardiac Rhythm Disease Management | 2005-11-15 |
| MEDTRONIC IMPLANTABLE CARDIO-VERTER DEFIBRILLATOR SYSTEMS ENTRUST ICOS (P980016/S058) | Medtronic Cardiac Rhythm Disease Management | 2005-11-15 |
| ENDOTAK RELIANCE AND ENDOTAK ENDURANCE (P910073/S055) | Boston Scientific | 2005-11-15 |
| AFFINITY/INTEGRITY, PHOTON, ATLAS, EPIC & PSA FAMILIES OF DEVICES (P030054/S015) | ABBOTT MEDICAL | 2005-11-15 |
| VITALITY FAMILY OF AICDS AND PRIZM 1 FAMILY OF AICDS (P960040/S086) | Boston Scientific | 2005-11-10 |
| CONTAK RENEWAL 1 (P010012/S076) | Boston Scientific Corp | 2005-11-10 |
| TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S025) | Boston Scientific Corp | 2005-11-10 |
| ST.JUDE MEDICAL RIATA/ RIATA I DEFIBRILLATION LEADS (P950022/S025) | ABBOTT MEDICAL | 2005-11-04 |
| IMPLANTABLE CARDIOVERTER DEFIBRILLATOR AND CARDIAC RESYNCHRONIZATION THERAPY DEVICES (ICD AND CRT-DS) (P030054/S013) | ABBOTT MEDICAL | 2005-11-02 |
| IMPLANTABLE CARDIOVERTER DEFIBRILLATOR AND CARDIAC RESYNCHRONIZATION THERAPY DEVICES (ICD AND CRT-DS) (P910023/S084) | ABBOTT MEDICAL | 2005-11-02 |
| WALLSTENT ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (TIPS) (P930031/S024) | Boston Scientific Corp | 2005-10-31 |
| MAGIC WALLSTENT ENDOPROSTHESIS (P980009/S013) | Boston Scientific Scimed, Inc. | 2005-10-31 |
| PTCA CATHETERS (P880027/S064) | Boston Scientific | 2005-10-31 |
| WALLSTENT ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (ILIAC) (P940019/S019) | Boston Scientific Scimed, Inc. | 2005-10-31 |
| TAXUS EXPRESS/EXPRESS2 MR & OTW CORONARY STENT SYSTEM (P030025/S016) | Boston Scientific Corp | 2005-10-31 |
| RADIUS CORONARY STENT WITH DELIVERY SYSTEM (P970061/S021) | Boston Scientific Scimed, Inc. | 2005-10-31 |
| EXPRESS/EXPRESS2 MR & OTW CORONARY STENT SYSTEMS (P020009/S021) | Boston Scientific Scimed, Inc. | 2005-10-31 |
| PTCA CATHETERS (P860019/S203) | Scimed Life Systems, Inc. | 2005-10-31 |
| WALLSTENT ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (VENOUS) (P980033/S013) | Boston Scientific Corporation | 2005-10-31 |
| LIBERTE CORONARY STENT SYSTEM (P040016/S006) | Boston Scientific Scimed, Inc. | 2005-10-28 |
| SYNCARDIA TEMPORARY CARDIOWEST TOTAL ARTIFICIAL HEART (TAH-T) (P030011/S001) | Syncardia Systems, LLC | 2005-10-26 |
| NAVISTAR DS AND CELSIUS DS DIAGNOSTIC/ABLATION CATHETERS (P010068/S007) | Biosense Webster, Inc. | 2005-10-21 |
| MEDTRONIC PACEMAKER SYSTEMS (P890003/S089) | Medtronic, Inc. | 2005-10-20 |
| MEDTRONIC CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR SYSTEMS (P010031/S026) | Medtronic Cardiac Rhythm Disease Management | 2005-10-20 |
| MEDTRONIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS (P900061/S057) | Medtronic Cardiac Rhythm Disease Management | 2005-10-20 |
| MEDTRONIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS (P980016/S056) | Medtronic Cardiac Rhythm Disease Management | 2005-10-20 |
| MEDTRONIC PACEMAKER SYSTEMS (P980035/S047) | Medtronic, Inc. | 2005-10-20 |
| MAESTRO 3000 TM CARDIAC ABLATION SYSTEM (P020025/S012) | Boston Scientific | 2005-10-18 |
| MAESTRO 3000 CARDIAC ABLATION SYSTEM (P980003/S016) | Boston Scientific Corp | 2005-10-18 |
| MAESTRO 3000 CARDIAC ABLATION SYSTEM & CATHETERS (P920047/S028) | Boston Scientific Corp | 2005-10-18 |
| NC STORMER OTW BALLOON DILATATION CATHETER (P790017/S084) | Medtronic, Ireland | 2005-10-17 |
| ICD/CRT-D (P030054/S012) | ABBOTT MEDICAL | 2005-10-17 |
| ISOFLEX S LEAD MODEL 1646T (P960030/S013) | ABBOTT MEDICAL | 2005-10-17 |
| IMPLANTABLE CARDIOVERTER DEFIBRILLATOR DEVICES (ICD AND CRT-D) (P910023/S083) | ABBOTT MEDICAL | 2005-10-17 |
| RELIANCE LEADS (P910073/S056) | Boston Scientific | 2005-10-17 |
| AFFINITY,IDENTITY,INTEGRITY & ENTITY IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P880086/S109) | ABBOTT MEDICAL | 2005-10-14 |
| AMPLATZER SEPTAL OCCLUDER (ASO) DEVICE (P000039/S010) | ABBOTT MEDICAL | 2005-10-13 |
| AMPLATZER DUCT OCCLUDER (P020024/S005) | ABBOTT MEDICAL | 2005-10-13 |
| MERLIN PATIENT CARE SYSTEM MODEL 3650 (P030054/S008) | ABBOTT MEDICAL | 2005-10-12 |
| CONTAK RENEWAL TR (P030005/S020) | Guidant Corp. | 2005-10-12 |
| XACT CAROTID STENT SYSTEM (P040038/S001) | Abbott Vascular, Inc. | 2005-10-12 |
| CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPROSTHESIS MODELS 6625LP AND 6625-ESR-LP (P870077/S020) | Edwards Lifesciences, LLC | 2005-10-07 |
| EDWARDS PRIMA PLUS STENTLESS BIOPROTHESIS, MODEL 2500P (P000007/S009) | Edwards Lifesciences, LLC | 2005-10-07 |
| CARPENTIER-EDWARDS SUPRAANNULAR (S.A.V.) BIOPROSTHESIS, MODEL 2650 (P010041/S009) | Edwards Lifesciences, LLC | 2005-10-07 |
| CARPENTIER-EDWARDS BIOPROSTHESIS, MODELS 2625 (P870056/S022) | Edwards Lifesciences, LLC | 2005-10-07 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS, MODELS 2700, 2700TFX, 2800, 2800TFX, 3000, 3000TFX,6900, 6900P (P860057/S030) | Edwards Lifesciences, LLC | 2005-10-07 |
| CARDIAC ABLATION CATHETERS (P920047/S029) | Boston Scientific Corp | 2005-10-06 |
| TAXUS EXPRESS 2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S023) | Boston Scientific Corp | 2005-10-06 |
| CORDIS CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S015) | Cordis Corp. | 2005-10-06 |