| PARADYM CRT-D (P060027/S017) | MicroPort CRM USA, Inc. | 2010-02-05 |
| CONSULTA CRT-D/MAXIMO II CRT-D/CONCERTO (P010031/S179) | Medtronic Cardiac Rhythm Disease Management | 2010-02-05 |
| HANCOCK STANDARD PORCINE BIOPROSTHESIS (P870078/S007) | Medtronic, Inc. | 2010-02-05 |
| MOSAIC PORCINE BIOPROSTHESIS (P990064/S031) | Medtronic, Inc. | 2010-02-05 |
| SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO (P980016/S219) | Medtronic Cardiac Rhythm Disease Management | 2010-02-05 |
| SYMPHONY & RHAPSODY SR/REPLY SR/DR/REPLY SR/DR (V2)/ESPRIT SR/DR (P950029/S050) | MicroPort CRM USA, Inc. | 2010-02-05 |
| HANCOCK II PORCINE BIOPROSTHESIS (P980043/S024) | Medtronic, Inc. | 2010-02-05 |
| TALENT ABDOMINAL STENT GRAFT SYSTEM (P070027/S011) | Medtronic Vascular | 2010-02-04 |
| VOYAGER NC CORONARY DILATATION CATHETER (P810046/S232) | Advanced Cardiovascular Systems, Inc. | 2010-02-04 |
| MICRONY PACEMAKERS (P970013/S032) | ABBOTT MEDICAL | 2010-02-03 |
| SENSOLOG/DIALOG/REGENCY PACEMAKERS (P880006/S065) | St. Jude Medical, Inc. | 2010-02-03 |
| EPIC HF/ATLAS/HF FAMILY OF CRT-DS (P030054/S137) | ABBOTT MEDICAL | 2010-02-03 |
| CADENCE FAMILY OF ICDS (P910023/S221) | ABBOTT MEDICAL | 2010-02-03 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S039) | Boston Scientific Corp | 2010-02-03 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S049) | Boston Scientific Scimed, Inc. | 2010-02-03 |
| FRONTIER/FRONTIER II FAMILY OF CRT-PS (P030035/S062) | ABBOTT MEDICAL | 2010-02-03 |
| GORE EXCULDER AAA ENDOPROSTHESIS (P020004/S045) | W. L. Gore & Associates, Inc. | 2010-02-03 |
| AFFINITY/IDENTITY/VERITY/INTERGRITY/VICTORY & ZEPHYR PACEMAKERS (P880086/S181) | ABBOTT MEDICAL | 2010-02-03 |
| CONCERTO II/CONSULTA CRT-D/MAXIMO II CRT-D (P010031/S167) | Medtronic Cardiac Rhythm Disease Management | 2010-02-03 |
| VIRTUOSO II DR/VR/SECURA DR/VR/MAXIMO II VR/DR (P980016/S206) | Medtronic Cardiac Rhythm Disease Management | 2010-02-03 |
| ATTAIN STARFIX LEAD (P060039/S006) | Medtronic, Inc. | 2010-02-02 |
| MAVERICK OVER-THE WIRE PTCA CATHETER (P860019/S247) | Scimed Life Systems, Inc. | 2010-02-01 |
| APEX PTCA DILATION CATHETERS (P860019/S232) | Scimed Life Systems, Inc. | 2010-02-01 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S034) | Boston Scientific Corp | 2010-01-29 |
| VERIFLEX (LIBERTE) BARE METAL CORONARY STENT SYSTEM (P040016/S048) | Boston Scientific Scimed, Inc. | 2010-01-29 |
| CADENCE FAMILY OF ICDS (P910023/S215) | ABBOTT MEDICAL | 2010-01-29 |
| TAXUS EXPRESS 2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S081) | Boston Scientific Corp | 2010-01-29 |
| EPIC HF CRT-D SYSTEM (P030054/S131) | ABBOTT MEDICAL | 2010-01-29 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S036) | Boston Scientific Corp | 2010-01-29 |
| EXPRESS/EXPRESS 2 CORONARY STENT SYSTEM (P020009/S057) | Boston Scientific Scimed, Inc. | 2010-01-29 |
| STARCLOSE SE VASCULAR CLOSURE SYSTEM (P050007/S023) | Abbott Vascular Devices | 2010-01-27 |
| ADDVENT/AFFINITY/IDENTITY/VERITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT/TRILOGY/SYNCHRONY/PARAGON/PHOENIX PACEMAKERS/CRT-PS (P880086/S184) | ABBOTT MEDICAL | 2010-01-22 |
| FRONTIER/FRONTIER II/ANTHEM/AESCULA PACEMAKERS/CRT-PS (P030035/S065) | ABBOTT MEDICAL | 2010-01-22 |
| STRATOS LV/LV-T (P070008/S014) | Biotronik, Inc. | 2010-01-22 |
| CADENCE/CADET/CONTOUR/CONTOUR II/MD/ATLAS II/MD/PROFILE II/MD/PHOTON/PHOTON MICRO/CURRENT/+/ATLAS II/+/EPIC II/+/CONVERT (P910023/S228) | ABBOTT MEDICAL | 2010-01-22 |
| ACTROS, AXIOS, KAIROS, CYLOS, DROMOS, PHILOS, AND PHILOS II FAMILIES OF PACEMAKER PULSE GENERATORS AND PROGRAMMERS (P950037/S074) | Biotronik, Inc. | 2010-01-22 |
| RIATA/RIATA ST/RIATA ST OPTIM/DURATA LEADS (P950022/S068) | ABBOTT MEDICAL | 2010-01-22 |
| BELOS & LEXOS DR/DR-T/VR/VR-T/LUMOS DR-T/VR-T/XELOS DR-T (P000009/S038) | Biotronik, Inc. | 2010-01-22 |
| QUICKSITE/QUICKFLEX LEADS/EPIC HF/+HF/EPIC II HF/II + HF/ATLAS HF/+ HF/II HF/II + HF/PROMOTE/PROMOTE + ICDS/CRT-DS (P030054/S143) | ABBOTT MEDICAL | 2010-01-22 |
| LUMAX 300/340/500/540 DR/DR-T/VR/VR-T/KRONOS LV-T/LUMAX 300/340/500/540 HF/HF-T (P050023/S028) | Biotronik, Inc. | 2010-01-22 |
| TENDRIL/TENDRIL ST/TENDRIL STS/OPTISENSE LEADS (P960013/S056) | ABBOTT MEDICAL | 2010-01-22 |
| ACTROS & AXIOS & KAIROS DR/SR/SLR/D/S/BA03 DDDR/CYLOS DR/DR-T/VR/DOMOS DR/SR/SL/PHILOS&PHILOS II DR/DR-T/SR/SLR/D/S/PROT (P950037/S076) | Biotronik, Inc. | 2010-01-22 |
| PASSIVE PLUS/ISOFLEX S & P/ISOFLEX OPTIM LEADS (P960030/S029) | ABBOTT MEDICAL | 2010-01-22 |
| STINGER/STRINGER S/STINGER M/STINGER SM/SCORPION/SCORPION M/SCORPION *2/SCORPION *2 M ABLATION CATHETERS (P000020/S013) | Boston Scientific Corp | 2010-01-21 |
| CAPSURE SP NOVUS LEADS AND CAPSURE SP LEADS (P830061/S047) | Medtronic Cardiac Rhythm Disease Management | 2010-01-21 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (P020026/S077) | Cordis Corp. | 2010-01-21 |
| KAPPA 700, 800 / 900 IPG FAMILY (P980035/S145) | Medtronic, Inc. | 2010-01-21 |
| MARQUIS IDC FAMILY, MAXIMO ICD FAMILY, INTRINSIC ICD FAMILY, ENTRUST ICD FAMILY (P980016/S209) | Medtronic Cardiac Rhythm Disease Management | 2010-01-21 |
| ANEURX AAADVANTAGE STENT GRAFT DELIVERY SYSTEM (P990020/S036) | Medtronic Vascular | 2010-01-21 |
| ATTAIN ABILITY LV LEAD (P080006/S003) | Medtronic, Inc. | 2010-01-21 |
| INSYNC II MARQUIS ICD (P010031/S170) | Medtronic Cardiac Rhythm Disease Management | 2010-01-21 |
| C-SERIES IPG DEVICES, T-SERIES IPG DEVICES DEMA FAMILY (P990001/S057) | Medtronic, Inc. | 2010-01-21 |
| PRODIGY IPG AND CAPSURE VDD LEADS (P890003/S175) | Medtronic, Inc. | 2010-01-21 |
| ATTAIN STARFIX LEAD (P060039/S007) | Medtronic, Inc. | 2010-01-21 |
| CAPSURE Z NOVUS LEADS, CAPSURE Z LEADS, CAPSURE SP LEADS AND CAPSURE SP NOVUS LEADS (P850089/S062) | Medtronic Cardiac Rhythm Disease Management | 2010-01-21 |
| INSYNC CRT-P, INSYNC III CRT-P, ATTAIN OTW LEAD, ATTAIN BIPOLAR OTW LEAD, ATTAIN CS LEAD AND ATTAIN LV LEAD (P010015/S073) | Medtronic, Inc. | 2010-01-21 |
| KAPPA 400 DR IPG AND KAPPA 400 SR IPG (P970012/S058) | Medtronic, Inc. | 2010-01-21 |
| CAPSUREFIX NOVUS LEAD, SUREFIX LEAD (P930039/S033) | Medtronic, Inc. | 2010-01-21 |
| TENDRIL LEADS (P960013/S052) | ABBOTT MEDICAL | 2010-01-20 |
| THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (P060040/S005) | ABBOTT MEDICAL | 2010-01-20 |
| PTCA DILATATION & FIRE STAR RX PTCA BALLOON DILATATION CATHETERS (P880003/S100) | Cordis Corp. | 2010-01-20 |
| VENTAK/PRX/VENTAK MINI I-IV (P910077/S101) | Boston Scientific | 2010-01-15 |
| VENTAK (P830060/S065) | Boston Scientific | 2010-01-15 |
| SWEET TIP RX/FLEXTEND (P960006/S026) | Boston Scientific | 2010-01-15 |
| CONTAK CD/EASYTRAK/LIVIAN/COGNIS/ACUITY (P010012/S232) | Boston Scientific Corp | 2010-01-15 |
| ACUITY STEERABLE (P050046/S006) | Guidant Corp. | 2010-01-15 |
| PRODIGY (P890003/S180) | Medtronic, Inc. | 2010-01-15 |
| ENDOTAK (P910073/S082) | Boston Scientific | 2010-01-15 |
| KAPPA 400 (P970012/S061) | Medtronic, Inc. | 2010-01-15 |
| THINLINE/FINELINE (P960004/S045) | Boston Scientific | 2010-01-15 |
| SELUTE (P950001/S021) | Boston Scientific | 2010-01-15 |
| VENTAK P2 (P930035/S019) | Boston Scientific | 2010-01-15 |
| VENTAK P (P890061/S018) | Boston Scientific | 2010-01-15 |
| ADAPTA/SENSIA/VERSA/RELIA (P980035/S154) | Medtronic, Inc. | 2010-01-15 |
| RES-Q/RES-Q MICRON (P940008/S026) | Boston Scientific | 2010-01-15 |
| CARPENTIER EDWARDS S.A.V. BIOPROSTHESIS (P010041/S022) | Edwards Lifesciences, LLC | 2010-01-14 |
| EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS (P000007/S023) | Edwards Lifesciences, LLC | 2010-01-14 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (P020026/S075) | Cordis Corp. | 2010-01-14 |
| ON-X PROSTHETIC HEART VALVE (P000037/S017) | On-X Life Technologies, Inc. | 2010-01-14 |
| CARPENTIER EDWARDS PORCINE BIOPROSTHESIS/CARPENTIER EDWARDS BIOPROSTHETIC VALVED CONDUIT (P870056/S037) | Edwards Lifesciences, LLC | 2010-01-14 |
| CARPENTIER EDWARDS DURAFLEX MITRAL LOW PRESSURE BIOPROSTHESIS (P870077/S034) | Edwards Lifesciences, LLC | 2010-01-14 |
| ADAPTA/VERSA/SENSIA/RELIA (P980035/S146) | Medtronic, Inc. | 2010-01-13 |
| SECURA/DR/VR/MAXIMO II DR/VR/VIRTUOSO II VR/DR (P980016/S208) | Medtronic Cardiac Rhythm Disease Management | 2010-01-13 |
| CONSULTA CRT-D/MAXIMO II CRT-D/CONCERTO II CRT-D (P010031/S169) | Medtronic Cardiac Rhythm Disease Management | 2010-01-13 |
| ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P060033/S045) | Medtronic, Inc. | 2010-01-13 |
| ACUITY STEERABLE (P050046/S005) | Guidant Corp. | 2010-01-12 |
| #2 BI-DIRETIONAL TORQUE WRENCH (P930035/S018) | Boston Scientific | 2010-01-12 |
| BIFURCATED BIPOLAR ENDOCARDIAL TINED LEAD/BIPOLAR ENDOCARDIAL LEAD/POSITIVE FIXATION PROTECTED HELIX BIPOLAR ENDOCARDIAL (P830060/S064) | Boston Scientific | 2010-01-12 |
| THINLINE II STEROX/THINLINE II STEROX/EZ/FINELINE II STEROX/EZ/TAPERED STYLET (P960004/S044) | Boston Scientific | 2010-01-12 |
| THERAPY CARDIAC ABLATION CATHETER (P040014/S012) | Irvine Biomedical, Inc. | 2010-01-12 |
| SELUTE PICOTIP BIPOLAR STERIOD ELUTING ENDOCARDIAL LEAD/SELUTE BIPOLAR STERIOD ELUTING ENDOCARDIAL LEAD/ATRAIL J SELUTE (P950001/S020) | Boston Scientific | 2010-01-12 |
| LEAD CAP ACCESSORY KIT (P940008/S025) | Boston Scientific | 2010-01-12 |
| SUPERIOR VENA CAVA LEAD (P890061/S017) | Boston Scientific | 2010-01-12 |
| THERAPY DUAL 8/THERAPY & SAFIRE TX ABLATION CATHETERS (P040042/S017) | Irvine Biomedical,Inc.(Ibi) | 2010-01-12 |
| ENDOTAK RELIANCE/S/ENDOTAK ENDURANCE EZ/ENDOTAK RELIANCE SG/G (P910073/S081) | Boston Scientific | 2010-01-12 |
| SWEET PICOTIP RX/FLEXTEND/SWEET TIP RX/FIXATION TOOL (P960006/S025) | Boston Scientific | 2010-01-12 |
| MYNX VASCULAR CLOSURE DEVICE (P040044/S024) | Cordis US Corporation | 2010-01-12 |
| CONTAK RENEWAL/3/3 HE/3 RF/LIVIAN RF1 SE/CONTAK RENEWAL 3 AVT/COGNIS (P010012/S231) | Boston Scientific Corp | 2010-01-12 |
| CONTAK RENEWAL TR (P030005/S060) | Guidant Corp. | 2010-01-12 |
| THERAPY COOL PATH ABLATION CATHETER (P060019/S010) | Irvine Biomedical, Inc. | 2010-01-12 |