| EXPRESS LD LLIAC PREMOUNTED STENT SYSTEM (P090003/S009) | Boston Scientific Corporation | 2011-03-09 |
| ARCTIC FRONT CARDIAC CRYOABLATION CATHETER (P100010/S003) | Medtronic Cryocath, LP | 2011-03-09 |
| PROTEGE GPS & PROTEGE RX CAROTID STENT SYSTEMS (P060001/S011) | Medtronic Vascular, Inc. | 2011-03-08 |
| SLS II SPECTRANETICS LASER SHEATHS (P960042/S028) | Spectranetics (Philips) | 2011-03-07 |
| FRONTIER/FRONTIER 2 FAMILY OF CRT-PS (P030035/S070) | ABBOTT MEDICAL | 2011-03-04 |
| EPIC HR/ATLAS + HF FAMILY OF CRT-DS (P030054/S153) | ABBOTT MEDICAL | 2011-03-04 |
| CADENCE FAMILY OF ICDS (P910023/S236) | ABBOTT MEDICAL | 2011-03-04 |
| AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS (P880086/S189) | ABBOTT MEDICAL | 2011-03-04 |
| SENSLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS (P880006/S067) | St. Jude Medical, Inc. | 2011-03-04 |
| MICRONY FAMILY OF PACEMAKERS (P970013/S034) | ABBOTT MEDICAL | 2011-03-04 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P070015/S056) | Abbott Vascular, Inc. | 2011-03-03 |
| NAVISTAR RMT CATHETER (P990025/S027) | Biosense Webster, Inc. | 2011-03-03 |
| NAVISTAR THERMOCOOL CATHETER FAMILY (P040036/S016) | Biosense Webster, Inc. | 2011-03-03 |
| LATITUDE PATIENT MANAGEMENT SYSTEM (P910077/S110) | Boston Scientific | 2011-03-03 |
| ADAPTA/RELIA/SENSIA/VERSA IPGS (P980035/S203) | Medtronic, Inc. | 2011-03-03 |
| NAVISTAR THERMOCOOL CATHETER FAMILY (P030031/S023) | Biosense Webster, Inc. | 2011-03-03 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (CYPHER (P020026/S081) | Cordis Corp. | 2011-03-03 |
| GLUTARALDEHYDE SOLUTION SYSTEM (P860057/S076) | Edwards Lifesciences, LLC | 2011-03-03 |
| WEBSTER ELECTROPHYSIOLOGY CATHETER/CELSIUS ABLATION CATHETER (P950005/S032) | Biosense Webster, Inc. | 2011-03-03 |
| TALENT THORACIC STENT GRAFT SYSTEM (P070007/S028) | Medtronic Vascular | 2011-03-03 |
| REPLY SR/DR & ESPIRIT SR/DR (P950029/S057) | MicroPort CRM USA, Inc. | 2011-03-03 |
| CELSIUS DS ABLATION CATHETER (P010068/S022) | Biosense Webster, Inc. | 2011-03-03 |
| CONCERTO II ICD/CONSULTA CRT-D/MAXIMO II CRT-D (P010031/S234) | Medtronic Cardiac Rhythm Disease Management | 2011-03-02 |
| SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II DR/VR ICDS (P980016/S278) | Medtronic Cardiac Rhythm Disease Management | 2011-03-02 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S057) | Boston Scientific Corp | 2011-03-01 |
| LINOX(SMART) S & LINOX(SMART) T STEROID-ELUTING DUAL-COIL ICD LEADS (P980023/S043) | Biotronik, Inc. | 2011-02-28 |
| ELCA CORONARY ATHERECTOMY CATHETERS (P910001/S044) | Spectranetics Corp. | 2011-02-28 |
| SLS SPECTRANETICS LASER SHEATHS (P960042/S026) | Spectranetics (Philips) | 2011-02-28 |
| VITATRON DA+C-SERIES/VITATRON DA+T SERIES (P990001/S083) | Medtronic, Inc. | 2011-02-24 |
| PRODIGY (P890003/S212) | Medtronic, Inc. | 2011-02-24 |
| ENTRUST/INTRINSIC/MARQUIS/MAXIMO/MAXIMO II/SECURA/VIRTUOSO/VIRTUOSO II (P980016/S277) | Medtronic Cardiac Rhythm Disease Management | 2011-02-24 |
| CONCERTO/CONCERTO II/CONSULTA/INSYNC II MARQUIS/INSYNC III MARQUIS/INSYNC MAXIMO/INSYNC SENTRY/MAXIMO II (P010031/S233) | Medtronic Cardiac Rhythm Disease Management | 2011-02-24 |
| GORE TAG THORACIC ENDOPROSTESIS (P040043/S037) | W. L. Gore & Associates, Inc. | 2011-02-24 |
| 350 SERIES/ADAPTA/AT500/ENPULSE/ENRHYTHM/KAPPA 700/800/900/RELIA/SENSIA/SIGMA/VERSA (P980035/S201) | Medtronic, Inc. | 2011-02-24 |
| INSYNC/INSYNC II (P010015/S108) | Medtronic, Inc. | 2011-02-24 |
| KAPPA 400 (P970012/S082) | Medtronic, Inc. | 2011-02-24 |
| DA+C SERIES & DA+T SERIES (P990001/S084) | Medtronic, Inc. | 2011-02-23 |
| ADAPTA/VERSA/SENSIA IPG/ENRHYTHM/RELIA IPG (P980035/S202) | Medtronic, Inc. | 2011-02-23 |
| AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILIES OF PACEMAKERS (P880086/S197) | ABBOTT MEDICAL | 2011-02-23 |
| ENTRUST/INTRINSIC/MARQUIS/MAXIMO/II DR/II VR/SECURA DR/VR/VIRTUOSO/II DR/II VR (P980016/S279) | Medtronic Cardiac Rhythm Disease Management | 2011-02-23 |
| FRONTIER/FRONTIER II/ANTHEM FAMILIES OF CRT-PS (P030035/S077) | ABBOTT MEDICAL | 2011-02-23 |
| CONCERTO CRT-D/CONCERTO II ICD/CONSULTA CRT-D/INSYNC II MARQUIS/PROTECT/INSYNC III MARQUIS/INSYNC MARQUIS/INSYNC MAXIMO (P010031/S235) | Medtronic Cardiac Rhythm Disease Management | 2011-02-23 |
| BETA-CATH SYSTEM (P000018/S044) | Best Vascular, Inc. | 2011-02-23 |
| SAFIRE BLU IRRIGATED ABLATION CATHETER & THERAPY COOL PATH CATHETER (P060019/S009) | Irvine Biomedical, Inc. | 2011-02-23 |
| CYPHER SIROLIMUS -ELUTING CORONARY STENT (4.0 MM) (P020026/S026) | Cordis Corp. | 2011-02-22 |
| AMPLATZER MUSCULAR VSD OCCLUDER (P040040/S016) | ABBOTT MEDICAL | 2011-02-18 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S035) | W. L. Gore & Associates, Inc. | 2011-02-18 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S024) | Zoll Manufacturing Corporation | 2011-02-18 |
| GORE HELEX SEPTAL OCCLUDER (P050006/S019) | W. L. Gore & Associates, Inc. | 2011-02-18 |
| SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM (P030011/S010) | Syncardia Systems, LLC | 2011-02-18 |
| AMPLATZER SEPTAL & CRIBRIFORM OCCLUDERS (P000039/S039) | ABBOTT MEDICAL | 2011-02-18 |
| ANGIO-SEAL VASCULAR CLOSURE DEVICE (P930038/S065) | Terumo Medical Corporation | 2011-02-18 |
| GORE EXCULDER AAA ENDOPROSTHESIS (P020004/S058) | W. L. Gore & Associates, Inc. | 2011-02-18 |
| AMPLATZER DUCT OCCLUDER (P020024/S031) | ABBOTT MEDICAL | 2011-02-18 |
| THERAPY COOL PATH ABLATION CATHETER (P060019/S017) | Irvine Biomedical, Inc. | 2011-02-17 |
| THERAPY/THERAPY BI-DIRECTIONAL/THERAPY 4MM THERMISTOR ABLATION CATHETERS (P040014/S016) | Irvine Biomedical, Inc. | 2011-02-17 |
| THERAPY DUAL 8/THERAPY 8MM THERMISTOR/SAFIRE TX ABLATION CATHETERS (P040042/S021) | Irvine Biomedical,Inc.(Ibi) | 2011-02-17 |
| MAXIMO II DR/VR/VIRTUOSO II DR/VR/SECURA DR/VR/VIRTUOSO/ENTRUST/MARQUIS/MAXIMO/INTRINSIC ICDS (P980016/S276) | Medtronic Cardiac Rhythm Disease Management | 2011-02-17 |
| CONCERTO II/MAXIMO II/CONSULTA/CONCERTO CRT-DS/INSYNC MAXIMO/SENTRY/INSYNC II MARQUIS/INSYNC III MARQUIS ICDS (P010031/S231) | Medtronic Cardiac Rhythm Disease Management | 2011-02-17 |
| BARD FLAIR ENDOVASCULAR STENT GRAFT (P060002/S017) | Bard Peripheral Vascular | 2011-02-16 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S034) | W. L. Gore & Associates, Inc. | 2011-02-16 |
| ON-X PROSTHETIC HEART VALVE (P000037/S022) | On-X Life Technologies, Inc. | 2011-02-16 |
| COMPLETE SE VASCULAR STENT SYSTEM (P090006/S002) | Medtronic Vascular | 2011-02-15 |
| PRECISE/PRECISE RX/PRECISE PRO RX NITINOL STENT SYSTEMS (P030047/S019) | Cordis US Corporation | 2011-02-14 |
| SAMERT NITINOL STENT SYSTEM AND SMART CONTROL NITINOL STENT SYSTEM (P020036/S016) | Cordis US Corporation | 2011-02-14 |
| RELIANCE 4-SITE (P910073/S092) | Boston Scientific | 2011-02-11 |
| LUMAX 300/340 DR-T/LUMAX 300/400 VR-T/LUMAX 500/540 DR-T/LUMAX 500/540 VR-T/LUMAX 540 VR-T DX (P050023/S041) | Biotronik, Inc. | 2011-02-11 |
| IMPLANTABLE CV DEFIBRILLATOR/PACEMAKER PROGRAMMER/ICD MONITORING SYSTEM (P000009/S043) | Biotronik, Inc. | 2011-02-11 |
| STRATOS LV/LV-T (P070008/S021) | Biotronik, Inc. | 2011-02-11 |
| ST. JUDE MEDICAL EPIC HF SYSTEM (P030054/S155) | ABBOTT MEDICAL | 2011-02-11 |
| ESTELLA AND EFFECTA PULSE GENERATORS (P950037/S092) | Biotronik, Inc. | 2011-02-11 |
| VIRTUOSO II/SECURA/MAXIMO II ICDS (P980016/S275) | Medtronic Cardiac Rhythm Disease Management | 2011-02-10 |
| DURATA FAMILY OF HIGH VOLTAGE LEADS (P950022/S076) | ABBOTT MEDICAL | 2011-02-10 |
| CONCERTO II/MAXIMO II/CONSULTA CRT-DS (P010031/S230) | Medtronic Cardiac Rhythm Disease Management | 2011-02-10 |
| PARADYM ICDS AND CRT-D DEVICES (P060027/S029) | MicroPort CRM USA, Inc. | 2011-02-10 |
| OVATIO DR AND VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (P980049/S062) | MicroPort CRM USA, Inc. | 2011-02-10 |
| SLS II LASER SHEATH (P960042/S025) | Spectranetics (Philips) | 2011-02-09 |
| REVO MRI SURESCAN IPG AND PACING SYSTEM (P090013) | Medtronic, Inc. | 2011-02-08 |
| ENDURANT STENT GRAFT SYSTEM (P100021/S001) | Medtronic Vascular | 2011-02-07 |
| ST JUDE MEDICAL MECHANICAL HEART VALVE (P810002/S072) | ABBOTT MEDICAL | 2011-02-07 |
| TALENT ABDOMINAL STENT GRAFT SYSTEM (P070027/S028) | Medtronic Vascular | 2011-02-07 |
| ANEURX AAADVANTAGE STENT GRAFT SYSTEM (P990020/S044) | Medtronic Vascular | 2011-02-07 |
| TALENT THORACIC STENT GRAFT SYSTEM (P070007/S027) | Medtronic Vascular | 2011-02-07 |
| EXPRESS LD LLIAC PREMOUNTED STENT SYSTEM (P090003/S005) | Boston Scientific Corporation | 2011-02-03 |
| TENDRIL LEADS (P960013/S063) | ABBOTT MEDICAL | 2011-02-03 |
| VIRTUOSO/SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II VR/DR ICDS (P980016/S274) | Medtronic Cardiac Rhythm Disease Management | 2011-02-03 |
| MITROFLOW AORTIC PERICARDIAL HEART VALVE (P060038/S009) | Corcym Canada Corp | 2011-02-03 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S046) | Abbott Vascular, Inc. | 2011-02-03 |
| NAVISTAR RMT DS CATHETER (8MM) (P010068/S021) | Biosense Webster, Inc. | 2011-02-03 |
| MULTI-LINK 8TM/MULTI-LINK 8 LLTM/MULTI-LINK 8TM SV CORONARY STENT SYSTEM (P020047/S023) | Abbott Vascular | 2011-02-03 |
| CELSIUS RMT CATHETER (4MM) (P950005/S031) | Biosense Webster, Inc. | 2011-02-03 |
| NAVISTAR RMT CATHETER (4MM) (P990025/S026) | Biosense Webster, Inc. | 2011-02-03 |
| ELCA CORONARY ATHERECTOMY CATHETERS (P910001/S043) | Spectranetics Corp. | 2011-02-03 |
| CONSULTA/CONSULTA II/MAXIMO II/CONCERTO CRT-DS (P010031/S229) | Medtronic Cardiac Rhythm Disease Management | 2011-02-03 |
| SMART & SMART CONTROL NITINOL STENT SYSTEMS (P020036/S020) | Cordis US Corporation | 2011-01-31 |
| BLAZER II CARDIAC ABLATION CATHETERS (P920047/S040) | Boston Scientific Corp | 2011-01-26 |
| BLAZER II XP CATHETERS (P020025/S021) | Boston Scientific | 2011-01-26 |
| DURATA FAMILY OF LEADS (P950022/S069) | ABBOTT MEDICAL | 2011-01-24 |
| CHILLI COOLED ABLATION SYSTEM (P980003/S027) | Boston Scientific Corp | 2011-01-21 |
| POWERLINK STENT GRAFT WITH 17FR. INTUITRAK ACCESSORY DELIVERY SYSTEM (P040002/S029) | Endologix, LLC | 2011-01-20 |