| PROTECTA DR/VR/XT DR/VR ICD (P980016/S302) | Medtronic Cardiac Rhythm Disease Management | 2011-06-10 |
| CONSULTA/SYNCRA CRT-PS (P010015/S123) | Medtronic, Inc. | 2011-06-09 |
| ENTRUST/INTRINSIC/MARQUIS/MAXIMO/II/II/II M4/PROTECTA/XT/PROTECT XT M4/PROTECTA M4/SECURA/SECURA M4/VIRTUOSO/II ICDS (P980016/S301) | Medtronic Cardiac Rhythm Disease Management | 2011-06-09 |
| REVO MRI IPG (P090013/S024) | Medtronic, Inc. | 2011-06-09 |
| ADAPTA/ADVISA/ENRHYTHM/RELIA/SENSIA/VERSA IPG (P980035/S225) | Medtronic, Inc. | 2011-06-09 |
| INTEGRITY CORONARY STENT SYSTEMS (P030009/S054) | Medtronic, Ireland | 2011-06-09 |
| PRODIGY IPG (P890003/S224) | Medtronic, Inc. | 2011-06-09 |
| CONCERTO/CONCERTO II/CONSULTA/DF4/INSYNC II/III/MAXIMO/SENTRY/MAXIMO II/II M4/PROTECTA XT/PROTECTA/PROTECTA XT M4/M4 (P010031/S255) | Medtronic Cardiac Rhythm Disease Management | 2011-06-09 |
| ELCA CORONARY ATHERECTOMY CATHETERS (P910001/S048) | Spectranetics Corp. | 2011-06-08 |
| ATTAIN ABILITY (P080006/S027) | Medtronic, Inc. | 2011-06-08 |
| SECURA DR/VR/VIRTUOSO II DR/VR/MAXIMO II DR/VR/ENTRUST/VIRTUOSO/MAXIMO/INTRINSIC/PROTECTA/PROTECTA XT (P980016/S300) | Medtronic Cardiac Rhythm Disease Management | 2011-06-08 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S063) | W. L. Gore & Associates, Inc. | 2011-06-08 |
| ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM (P980037/S037) | Boston Scientific Corp | 2011-06-08 |
| REVO MRI IPG (P090013/S023) | Medtronic, Inc. | 2011-06-08 |
| CONCERTO ICD/CONSULTA/CONCERTO II/MAXIMO II CRT-D/INSYNC II/III MARQUIS/MARQUIS DR/INSYNC MARQUIS/MAXIMO/SENTRY (P010031/S254) | Medtronic Cardiac Rhythm Disease Management | 2011-06-08 |
| PRODIGY IPG (P890003/S223) | Medtronic, Inc. | 2011-06-08 |
| SLS SPECTRANETICS LASER SHEATHS (P960042/S030) | Spectranetics (Philips) | 2011-06-08 |
| SYNCRA/CONSULTA CRT-P (P010015/S122) | Medtronic, Inc. | 2011-06-08 |
| ADAPTA/VERSA/SENSIA/SIGMA/RELIA/ADVISA DR/ENRHYTHM IPGS (P980035/S224) | Medtronic, Inc. | 2011-06-08 |
| SUSTAIN XL FAMILY OF PACEMAKERS (P880086/S204) | ABBOTT MEDICAL | 2011-06-08 |
| ION (TAXUS ELEMENT) PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL & OTW) (P100023/S001) | Boston Scientific Corp | 2011-06-07 |
| ZENITH FLEX AAA ENDOVASCULAR GRAFT (P020018/S037) | Cook, Inc. | 2011-06-07 |
| THERAPY CARDIAC ABLATION CATHETER (P040014/S017) | Irvine Biomedical, Inc. | 2011-06-06 |
| THERAPY DUAL 8/THERAPY 8MM THERMISTOR/SAFIRE TX ABLATION CATHETERS (P040042/S022) | Irvine Biomedical,Inc.(Ibi) | 2011-06-06 |
| MEDTRONIC ATTAIN ABILITY MODEL 4196 LEFT VENTRICULAR LEAD (P080006/S026) | Medtronic, Inc. | 2011-06-02 |
| ENDOTAK RELIANCE TACHY LEAD (P910073/S097) | Boston Scientific | 2011-06-02 |
| ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S064) | Medtronic, Inc. | 2011-06-02 |
| CONTRAK RENEWAL TR (P030005/S076) | Guidant Corp. | 2011-06-02 |
| ADAPTA, VERSA, SENSIA, RELIA IPGS (P980035/S227) | Medtronic, Inc. | 2011-06-02 |
| EXPRESS LD LLIAC PREMOUNTED STENT SYSTEM (P090003/S011) | Boston Scientific Corporation | 2011-05-31 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OVER-THE-WIRE DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTE (P020026/S059) | Cordis Corp. | 2011-05-27 |
| CYPHER SIROLIMUS CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (CYPHER STENT (P020026/S083) | Cordis Corp. | 2011-05-27 |
| REVO MRI SURESCAN PACING SYSTEM (P090013/S012) | Medtronic, Inc. | 2011-05-27 |
| REVO MRI SURESCAN PACING SYSTEM (P090013/S013) | Medtronic, Inc. | 2011-05-27 |
| CARELINK MONITOR 2490G (P890003/S220) | Medtronic, Inc. | 2011-05-27 |
| PROTECTA & PROTECTA XT CRT-DS (P010031/S249) | Medtronic Cardiac Rhythm Disease Management | 2011-05-26 |
| STRATOS LV/LV-T/COROX OTW (-S) BP/COROX OTW-L BP (P070008/S023) | Biotronik, Inc. | 2011-05-26 |
| PROTEGE GPS & PROTEGE RX CAROTID STENT SYSTEM (P060001/S012) | Medtronic Vascular, Inc. | 2011-05-26 |
| LUMAX 300/340 VR-T/DR-T/HF-T/LUMAX 500/540 VR-T/DR-T/HF-T/LUMAX 540 VR-T DX (P050023/S045) | Biotronik, Inc. | 2011-05-26 |
| ADAPTA/VERSA/SENSIA/RELIA/ENRHYTHM/ADVISA DR/KAPPA 700/800/900/SIGMA/MEDTRONIC 350 IPG SERIES/ENPULSE/AT500 SYSTEMS IPGS (P980035/S222) | Medtronic, Inc. | 2011-05-26 |
| EVIA/ENTOVIS/ESTELLA/EFFECTA/ECURO (P950037/S096) | Biotronik, Inc. | 2011-05-26 |
| CONSULTA & SYNCRA CRT-P (P010015/S119) | Medtronic, Inc. | 2011-05-26 |
| REVO MRI IPG (P090013/S021) | Medtronic, Inc. | 2011-05-26 |
| KAPPA 400 DR/SR IPG (P970012/S084) | Medtronic, Inc. | 2011-05-26 |
| DEMA IPGS/C & T SERIES IPGS (P990001/S088) | Medtronic, Inc. | 2011-05-26 |
| MEDTRONIC REVO MRI SURESCAN PACING SYSTEM (P090013/S022) | Medtronic, Inc. | 2011-05-26 |
| ADVISA (P980035/S219) | Medtronic, Inc. | 2011-05-26 |
| REVO MRI (P090013/S019) | Medtronic, Inc. | 2011-05-26 |
| PROTECTA + PROTECTA XT (P980016/S295) | Medtronic Cardiac Rhythm Disease Management | 2011-05-26 |
| INSYNC SENTRY CRT-D/CONCERTO ICD/CONSULTA CRT-D/CONCERTO II CRT-D/MAXIMO II CRT-D/PROTECTA/XT CRT-D (P010031/S253) | Medtronic Cardiac Rhythm Disease Management | 2011-05-26 |
| SECURA DR/VR/VIRTUOSO II DR/VR/MAXIMO II DR/VR/ENTRUST/VIRTUOSO/PROTECTA DR/VR/PTOTECTA XT DR/VR/INSYNC II/III MARQUIS (P980016/S299) | Medtronic Cardiac Rhythm Disease Management | 2011-05-26 |
| LEXOS DR/DR-T/VR/VR-T/LUMOS DR-T/VR-T ICDS (P000009/S045) | Biotronik, Inc. | 2011-05-26 |
| LINOX(SMART) S & LINOX(SMART) T STEROID-ELUTING DUAL-COIL ICD LEADS (P980023/S044) | Biotronik, Inc. | 2011-05-26 |
| VALIANT THORACIC STENT GRAFT WITH THE CAPTIVIA DELIVERY SYSTEM (P100040/S003) | Medtronic Vascular | 2011-05-25 |
| XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S054) | Abbott Vascular, Inc. | 2011-05-24 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S070) | Boston Scientific Corp | 2011-05-24 |
| ARCTIC FRONT CARDIAC CRYOABLATION CATHETER (P100010/S007) | Medtronic Cryocath, LP | 2011-05-23 |
| PROTECTA DR/VR/PROTECTA XT DR/VR (P980016/S296) | Medtronic Cardiac Rhythm Disease Management | 2011-05-23 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S036) | Abbott Vascular, Inc. | 2011-05-23 |
| CONSULTA/SYNCRA CRT-PS (P010015/S120) | Medtronic, Inc. | 2011-05-23 |
| ATTAIN ABILITY PLUS/STRAIGHT (P080006/S024) | Medtronic, Inc. | 2011-05-23 |
| PROTECTA/PROTECTA XT CRT-DS (P010031/S250) | Medtronic Cardiac Rhythm Disease Management | 2011-05-23 |
| ADVISA DR (P980035/S220) | Medtronic, Inc. | 2011-05-23 |
| ADAPTA/RELIA/SENSIA/VERSA (P980035/S209) | Medtronic, Inc. | 2011-05-19 |
| ATTAIN STARFIX (P060039/S025) | Medtronic, Inc. | 2011-05-19 |
| CAPSURE/CAPSURE MODEL/PRODIGY/SERVICE KIT-PACEMAKER REPAIR KIT (P890003/S221) | Medtronic, Inc. | 2011-05-19 |
| CAPSURE EPICARDIAL PACING LEAD (P950024/S031) | Medtronic, Inc. | 2011-05-19 |
| ADAPTOR:EPG SAFETY CABLE (P820003/S105) | Medtronic Cardiac Rhythm Disease Management | 2011-05-19 |
| TRANSVENOUS BIPOLAR PACING LEAD (P960006/S029) | Boston Scientific | 2011-05-19 |
| ENTRUST/INTRINSIC/MARQUIS/MAXIMO/II/PROTECTA XT/ICD/SECURA/VIRTUOSO II (P980016/S297) | Medtronic Cardiac Rhythm Disease Management | 2011-05-19 |
| CONCERTO II/CONSULTA/INSYNC II MARQUIS/III MARQUIS/INSYNC MAXIMO/SENTRY/MAXIMO II/PROTECTA/PROTECTA XT (P010031/S251) | Medtronic Cardiac Rhythm Disease Management | 2011-05-19 |
| REVO MRI IPG (P090013/S017) | Medtronic, Inc. | 2011-05-19 |
| VITATRON DA+ C & T SERIES (P990001/S087) | Medtronic, Inc. | 2011-05-19 |
| ENRHYTHM IPG (P980035/S218) | Medtronic, Inc. | 2011-05-19 |
| MULTI-LINK VISION & MULTI-LINK MINI-VISION OTW & RX; ML-8 (P020047/S032) | Abbott Vascular | 2011-05-19 |
| 350 SERIES/ADAPTA/ADVISA/ENRHYTHM/RELIA/SENSIA/SIGMA/VERSA (P980035/S221) | Medtronic, Inc. | 2011-05-19 |
| ATTAIN/CONSULTA CRT-P/INSYNC III/SYNCRA CRT-P (P010015/S121) | Medtronic, Inc. | 2011-05-19 |
| CAPSURE/SUREFIX/VITATRON CRYSTALLINE ACTFIX/PIROUET S+ (P930039/S052) | Medtronic, Inc. | 2011-05-19 |
| CAPSURE/VITATRON CRYSTALINE/EXCELLENCE +/EXCELLENCE PS+ (P830061/S063) | Medtronic Cardiac Rhythm Disease Management | 2011-05-19 |
| ACCESSORY (UPSIZING SLEEVE) ACE/ACE 5434T/ACE HEADER/LEAD END PIN CAP (P900061/S102) | Medtronic Cardiac Rhythm Disease Management | 2011-05-19 |
| CATH RF CONDUCTR/5 MM 8FR/RF MC 078 6022/CONTACTR CATHETER 7 FR 5MM/RF CONDUCTR MC SELF-REFERENCE CATHETER/RF ENHANCR II (P930029/S029) | Medtronic, Inc. | 2011-05-19 |
| Y ADAPTOR/EXTENDER KIT/DF-1 CONNECTOR PORT PIN PLUG/ LEAD ADAPTOR/SPRINT/SPRINT QUATTRO/QUATTRO LEAD/SUBCUTANEOUS LEAD (P920015/S076) | Medtronic, Inc. | 2011-05-19 |
| XIENCE V & PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S060) | Abbott Vascular, Inc. | 2011-05-19 |
| ATTAIN ABILITY/ABILITY PLUS/ABILITY STRAIGHT (P080006/S025) | Medtronic, Inc. | 2011-05-19 |
| CORDIS EXOSEAL VASCULAR CLOSURE DEVICE (P100013) | Cordis US Corporation | 2011-05-19 |
| SELECTSECURE (P030036/S030) | Medtronic Cardiac Rhythm Disease Management | 2011-05-19 |
| TRANSVENE CS/SVC LEAD (P980050/S061) | Medtronic, Inc. | 2011-05-19 |
| REVO MRI (P090013/S020) | Medtronic, Inc. | 2011-05-19 |
| CAPSURE/CAPSURE Z NOVUS/VITATRON EXCELLENCE S+/SS+/IMPULSE/IMPULSE II (P850089/S076) | Medtronic Cardiac Rhythm Disease Management | 2011-05-19 |
| CONSULTA & SYNCRA CRT-P (P010015/S118) | Medtronic, Inc. | 2011-05-18 |
| SELECTSECURE 4 FRENCH LEAD (P030036/S029) | Medtronic Cardiac Rhythm Disease Management | 2011-05-18 |
| CAPSURE FIX LEAD (P090013/S018) | Medtronic, Inc. | 2011-05-18 |
| ATTAIN ABILITY LV/PLUS LV/STRAIGHT LV LEADS (P080006/S023) | Medtronic, Inc. | 2011-05-18 |
| CAPSURE FIX NOVUS/VITATRON (P930039/S051) | Medtronic, Inc. | 2011-05-18 |
| REVO MRI (P090013/S016) | Medtronic, Inc. | 2011-05-18 |
| ADVISA DR (P980035/S217) | Medtronic, Inc. | 2011-05-18 |
| VENTAK PRX AICD SYSTEM (P910077/S111) | Boston Scientific | 2011-05-17 |
| PROTEGE GPS & PROTEGE RX CAROTID STENT SYSTEM (P060001/S013) | Medtronic Vascular, Inc. | 2011-05-17 |
| CONTAK CD/EASYTRACK CRT-D SYSTEM (P010012/S265) | Boston Scientific Corp | 2011-05-17 |
| VIGOR DR/SR PACEMAKER SYSTEM (P940031/S070) | Boston Scientific | 2011-05-17 |