| LINOX SD, TD & S/T (P980023/S030) | Biotronik, Inc. | 2008-02-29 |
| SELOX ST/JT, SETROX S & DEXTRUS (P950037/S056) | Biotronik, Inc. | 2008-02-29 |
| LIBERTE CORONARY STENT SYSTEM (P030025/S053) | Boston Scientific Corp | 2008-02-27 |
| EXPRESS2 CORONARY STENT SYSTEM (P020009/S041) | Boston Scientific Scimed, Inc. | 2008-02-27 |
| AMPLATZER SEPTAL OCCLUDER AND MULTI-FENESTRATED SEPTAL OCCLUDER (P000039/S024) | ABBOTT MEDICAL | 2008-02-27 |
| AMPLATZER MUSCULAR VSD OCCLUDER (P040040/S003) | ABBOTT MEDICAL | 2008-02-27 |
| MAVERICK2 MONORAIL AND MAVERICK OTW PTCA CATHETER, QUANTUM MAVERICK PTCA CATHETER (P860019/S222) | Scimed Life Systems, Inc. | 2008-02-27 |
| TAXUS? EXPRESS2 PACLITAXEL ELUTING STENT SYSTEM (P040016/S028) | Boston Scientific Scimed, Inc. | 2008-02-27 |
| DUCT OCCLUDER (P020024/S018) | ABBOTT MEDICAL | 2008-02-27 |
| CRT'S (P030054/S054) | ABBOTT MEDICAL | 2008-02-25 |
| GORE TAG THORACIC ENDOPROTHESIS (P040043/S017) | W. L. Gore & Associates, Inc. | 2008-02-25 |
| CONTAK RENEWAL RF HEART FAILURE PULSE GENERATORS (P010012/S171) | Boston Scientific Corp | 2008-02-25 |
| EASYTRAK 2 (P010012/S172) | Boston Scientific Corp | 2008-02-25 |
| ICD'S (P910023/S136) | ABBOTT MEDICAL | 2008-02-25 |
| LIVEWIRE TC CARDIAC ABLATION SYSTEM (P960016/S022) | St Jude Medical | 2008-02-22 |
| CARELINK PROGRAMMER, MODEL 2090 (P890003/S134) | Medtronic, Inc. | 2008-02-21 |
| POWERLINK SYSTEM ANEURYSM STENT GRAFT (P040002/S013) | Endologix, LLC | 2008-02-21 |
| KAPPA 700/600,650,800/900 FAMILY, SIGMA FAMILY, MEDTRONIC 350 SERIES, ENPILSE 2 FAMILY ENRHYTHM, ADAPTA/VERSA/SESIA FAM (P980035/S086) | Medtronic, Inc. | 2008-02-21 |
| KAPPA 400 DR, KAPPA 400 SR (P970012/S033) | Medtronic, Inc. | 2008-02-21 |
| MARQUIS, MAXIMO, INTRINSIC FAMILY, ONYX, VIRTUOSO, ENTRUST FAMILY, (P980016/S122) | Medtronic Cardiac Rhythm Disease Management | 2008-02-21 |
| INSYNC PULSE GENERATOR, INSYNC 3 PULSE GENERATOR (P010015/S037) | Medtronic, Inc. | 2008-02-21 |
| RX ACCULINK CAROTID STENT SYSTEM (P040012/S027) | Abbott Vascular | 2008-02-21 |
| C-SERIES DEVICES AND T-SERIES DEVICES (P990001/S035) | Medtronic, Inc. | 2008-02-21 |
| INSYNC MARQUIS, INSYNC 2 & 3 MARQUIS, INSYNC 2 &3 PROTECT INSYNC SENTRY FAMILY, INSYNC MAXIMO FAMILY, CONCERTO (P010031/S092) | Medtronic Cardiac Rhythm Disease Management | 2008-02-21 |
| PRODIGY (P890003/S136) | Medtronic, Inc. | 2008-02-21 |
| PREVAIL (P850051/S067) | Medtronic, Inc. | 2008-02-21 |
| AFFINITY, IDENTITY, INTEGRITY & VICTORY/ZEPHYR FAMILY OF DEVICES (P880086/S159) | ABBOTT MEDICAL | 2008-02-20 |
| DRIVER AND MICRO-DRIVER CORONARY STENT SYSTEMS (P030009/S013) | Medtronic, Ireland | 2008-02-15 |
| LIVIAN CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (P010012/S154) | Boston Scientific Corp | 2008-02-15 |
| MEDTRONIC VASCULAR ANEURX AAADVANTAGE STENT GRAFT WITH XCELERANT DELIVERY SYSTEM (P990020/S030) | Medtronic Vascular | 2008-02-15 |
| MEDTRONIC ATTAIN OTW LV LEAD MODEL 4193 (P010015/S030) | Medtronic, Inc. | 2008-02-14 |
| DURATA LEADS (P950022/S050) | ABBOTT MEDICAL | 2008-02-14 |
| XACT CAROTID STENT SYSTEM (P040038/S012) | Abbott Vascular, Inc. | 2008-02-14 |
| VENTAK IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (P960040/S147) | Boston Scientific | 2008-02-13 |
| VITALITY & VITALITY 2 DEVICE FAMILY (P960040/S160) | Boston Scientific | 2008-02-13 |
| DRIVER OVER THE WIRE (OTW) & DRIVER MULTI-EXCHANGE (MX) CORONARY STENT SYSTEMS (P030009/S018) | Medtronic, Ireland | 2008-02-13 |
| GORE HELEX SEPTAL OCCLUDER (P050006/S004) | W. L. Gore & Associates, Inc. | 2008-02-13 |
| SYMPHONY & ELA RHAPSODY PACEMAKERS (P950029/S033) | MicroPort CRM USA, Inc. | 2008-02-13 |
| EASYTRAK 3 FAMILY OF LEADS (P010012/S167) | Boston Scientific Corp | 2008-02-11 |
| AT 500 IPG & ENRHYTHM IPG (P980035/S077) | Medtronic, Inc. | 2008-02-08 |
| INSYNC FAMILIES OF ICD & CONCERTO ICD (P010031/S079) | Medtronic Cardiac Rhythm Disease Management | 2008-02-08 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S046) | Cordis Corp. | 2008-02-08 |
| VOYAGER RX CORONARY DILATATION CATHETER (P810046/S225) | Advanced Cardiovascular Systems, Inc. | 2008-02-08 |
| LUMAX FAMILY OF ICDS AND CRT-DS (P050023/S010) | Biotronik, Inc. | 2008-02-08 |
| INSYNC III CRT-P (P010015/S032) | Medtronic, Inc. | 2008-02-08 |
| GEM III AT ICD (P980050/S029) | Medtronic, Inc. | 2008-02-08 |
| VARIOUS FAMILES OF ICDS (P980016/S109) | Medtronic Cardiac Rhythm Disease Management | 2008-02-08 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S021) | W. L. Gore & Associates, Inc. | 2008-02-07 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S033) | W. L. Gore & Associates, Inc. | 2008-02-07 |
| MEDTRONIC SPRINT LEADS (P920015/S038) | Medtronic, Inc. | 2008-02-06 |
| RENEWAL & VITALITY FAMILY OF ICDS (P010012/S170) | Boston Scientific Corp | 2008-02-06 |
| RENEWAL & VITALITY FAMILY OF ICDS (P960040/S159) | Boston Scientific | 2008-02-06 |
| EZ STEER 8MM NAVIGATIONAL BI-DIRECTIONAL CATHETERS (P010068/S012) | Biosense Webster, Inc. | 2008-02-01 |
| EZ STEER 4MM NAVIGATIONAL BI-DIRECTIONAL CATHETERS (P990025/S015) | Biosense Webster, Inc. | 2008-02-01 |
| ENDEAVOR ZOTAROLIMUS ELUTING CORONARY STENT SYSTEM (P060033) | Medtronic, Inc. | 2008-02-01 |
| EZ STEER 8MM AND 4MM NON-NAVIGATIONAL BI-DIRECTIONAL CATHETERS (P950005/S024) | Biosense Webster, Inc. | 2008-02-01 |
| CAPSUREFIX NOVUS & VITATRON (P930039/S024) | Medtronic, Inc. | 2008-02-01 |
| THORATEC IMPLANTATION VENTRICULAR ASSIST DEVICE (IVAD) SYSTEM (P870072/S039) | Thoratec Laboratories Corp. | 2008-01-31 |
| PROTEGE GPS & PROTEGE RX CAROTID STENT SYSTEM (P060001/S004) | Medtronic Vascular, Inc. | 2008-01-30 |
| VARIOUS ICD FAMILIES & LATITUDE COMMUNICATOR (P910077/S083) | Boston Scientific | 2008-01-30 |
| PRIZM & VITALITY PG CONFIENT ICD (P960040/S156) | Boston Scientific | 2008-01-30 |
| RENEWAL 3 RF CONTAK & RENEWAL PG, LIVIAN CRT-D (P010012/S166) | Boston Scientific Corp | 2008-01-30 |
| AMPLATZER MUSCULAR VSD OCCLUDER (P040040/S002) | ABBOTT MEDICAL | 2008-01-25 |
| PRIZM, PRIZM AT & VITALITY FAMILES (P960040/S157) | Boston Scientific | 2008-01-25 |
| VITALITY HE (P960040/S158) | Boston Scientific | 2008-01-25 |
| CONTAK RENEWAL (P010012/S169) | Boston Scientific Corp | 2008-01-25 |
| CONTAK RENEWAL FAMILY (P010012/S168) | Boston Scientific Corp | 2008-01-25 |
| EPIC HF FAMILY OF CRT-DS (P030054/S078) | ABBOTT MEDICAL | 2008-01-24 |
| CADENCE FAMILY OF ICDS (P910023/S166) | ABBOTT MEDICAL | 2008-01-24 |
| CADENCE ICDS (P910023/S165) | ABBOTT MEDICAL | 2008-01-17 |
| LIBERTE CORONARY STENT SYSTEM (P040016/S027) | Boston Scientific Scimed, Inc. | 2008-01-17 |
| CARDIOSEAL SEPTAL OCCLUSION WITH QWIK LOAD (P000049/S019) | Nmt Medical, Inc. | 2008-01-17 |
| CONTAK TR 2 (P030005/S049) | Guidant Corp. | 2008-01-17 |
| STARCLOSE VASCULAR CLOSURE SYSTEM (P050007/S008) | Abbott Vascular Devices | 2008-01-17 |
| EPIC HF CRT-DS (P030054/S077) | ABBOTT MEDICAL | 2008-01-17 |
| TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S052) | Boston Scientific Corp | 2008-01-17 |
| ENTRUST & VIRTUOSO (P980016/S119) | Medtronic Cardiac Rhythm Disease Management | 2008-01-16 |
| CONCERTO (P980035/S084) | Medtronic, Inc. | 2008-01-16 |
| ENRHYTHM (P010031/S089) | Medtronic Cardiac Rhythm Disease Management | 2008-01-16 |
| CORDIS PRECISE RX NITINOL STENT SYSTEM (P030047/S010) | Cordis US Corporation | 2008-01-16 |
| ISOLINE 2CR DEFIBRILLATION LEADS (P980049/S021) | MicroPort CRM USA, Inc. | 2008-01-15 |
| STARCLOSE VASCULAR CLOSURE SYSTEM (P050007/S007) | Abbott Vascular Devices | 2008-01-11 |
| VASOSEAL (P920004/S021) | St. Jude Medical, Inc. | 2008-01-11 |
| CADENCE ICDS (P910023/S164) | ABBOTT MEDICAL | 2008-01-11 |
| FX MINIRAIL PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER (P020037/S002) | Abbott Vascular, Inc. | 2008-01-11 |
| EPIC HF CRT-DS (P030054/S076) | ABBOTT MEDICAL | 2008-01-11 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S016) | W. L. Gore & Associates, Inc. | 2008-01-11 |
| DURATA (P950022/S049) | ABBOTT MEDICAL | 2008-01-10 |
| ISOLINE 2CR DEFIBRILLATION LEADS MODELS 2CR5, 2CR6 AND 2CR7 (P980049/S024) | MicroPort CRM USA, Inc. | 2008-01-09 |
| NAVISTAR RMT THERMOCOOL LINE EXTENSION (P040036/S003) | Biosense Webster, Inc. | 2008-01-04 |
| MEDTRONIC VASCULAR ANEURX AAADVANTAGE STENT GRAFT WITH XCELERANT DELIVERY SYSTEM (P990020/S029) | Medtronic Vascular | 2008-01-04 |
| CADENCE, CADET, CONTOUR, ANGSTROM, PROFILE, PHOTON, EPIC & ATLAS ICD FAMILIES (P910023/S163) | ABBOTT MEDICAL | 2008-01-04 |
| NAVISTAR RMT THERMOCOOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS (P030031/S005) | Biosense Webster, Inc. | 2008-01-04 |
| MODELS 8090 OR 2290 PACING SYSTEM ANALYZER (P890003/S133) | Medtronic, Inc. | 2008-01-04 |
| EPIC HF & HF CRT-D FAMILIES (P030054/S075) | ABBOTT MEDICAL | 2008-01-04 |
| CONCERTO (P010031/S088) | Medtronic Cardiac Rhythm Disease Management | 2008-01-03 |
| VIRTUOSO (P980016/S118) | Medtronic Cardiac Rhythm Disease Management | 2008-01-03 |
| TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S050) | Boston Scientific Corp | 2007-12-27 |
| RIATA ST FAMILY OF LEADS (P950022/S046) | ABBOTT MEDICAL | 2007-12-21 |
| AB5000 CIRCULATORY SUPPORT SYSTEM (P900023/S048) | Abiomed Cardiovascular, Inc. | 2007-12-21 |