| EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS (P000007/S030) | Edwards Lifesciences, LLC | 2012-04-13 |
| BIOCOR & BIOCOR SUPRA VALVES, EPIC & EPIC SUPRA VALVES (P040021/S021) | ABBOTT MEDICAL | 2012-04-13 |
| TRANSTELEPHONIC FOLLOW-UP/MONITORING SYSTEM (P910023/S281) | ABBOTT MEDICAL | 2012-04-13 |
| MOSIAC PORCINE BIOPROSTHESIS (P990064/S042) | Medtronic, Inc. | 2012-04-13 |
| ARCHITECT CORE (P080023/S014) | Abbott Laboratories | 2012-04-13 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING CHRONIUM CORONARY STENT SYSTEM (P110010/S012) | Boston Scientific Corp | 2012-04-13 |
| CARPENTIER-EDWARDS® SUPRAANNULAR (S.A.V.) BIOPROSTHESIS (P010041/S032) | Edwards Lifesciences, LLC | 2012-04-13 |
| VNS THERAPY SYSTEM GENERATORS (P970003/S147) | LivaNova USA, Inc. | 2012-04-13 |
| TENDRIL AND OPTISENSE LEAD FAMILIES (P960013/S071) | ABBOTT MEDICAL | 2012-04-13 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING CORONARY STENT SYSTEM (P110010/S009) | Boston Scientific Corp | 2012-04-13 |
| VARIOUS FAMILIES OF CURRENT, ATLAS, EPIC, CONVERT, CURRENT, & FORTIFY ICD'S (P910023/S291) | ABBOTT MEDICAL | 2012-04-13 |
| CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE (P960030/S034) | ABBOTT MEDICAL | 2012-04-13 |
| CARPENTIER-EDWARDS® DURAFLEX LOW PRESSURE PORCINE MITRAL BIOPROSTHES (P870077/S043) | Edwards Lifesciences, LLC | 2012-04-13 |
| DERMAGRAFT (P000036/S010) | Shire Regenerative Medicine | 2012-04-13 |
| IDENTITY, VERITY, SUSTAIN, VICTORY, ZEPHYR, & ACCENT FAMILIES OF IPG'S (P880086/S216) | ABBOTT MEDICAL | 2012-04-13 |
| ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P970038/S016) | Beckman Coulter, Inc. | 2012-04-13 |
| ACCESS AFB REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P980041/S017) | Beckman Coulter, Inc. | 2012-04-13 |
| IMPLANTABLE PACEMAKER PULSE GENERATOR (P970013/S045) | ABBOTT MEDICAL | 2012-04-13 |
| ZENITH AAA ENDOVASCULAR GRAFT (P020018/S042) | Cook, Inc. | 2012-04-13 |
| CARPENTIER-EDWARDS® PORCINE BIOPROSTHESIS (P870056/S048) | Edwards Lifesciences, LLC | 2012-04-13 |
| EPIC SELF-EXPANDING NITINOL STENT SYSTEM (P110035) | Boston Scientific Corp | 2012-04-13 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S037) | Boston Scientific Corp | 2012-04-13 |
| TRIFECTA VALVE (P100029/S011) | ABBOTT MEDICAL | 2012-04-13 |
| TRANSVENOUS DEFIBRILLATION LEAD (P950022/S080) | ABBOTT MEDICAL | 2012-04-13 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S092) | Abbott Vascular, Inc. | 2012-04-13 |
| FRONTIER, FRONTIER II, ANTHEM FAMILIES OF CRTP'S (P030035/S094) | ABBOTT MEDICAL | 2012-04-13 |
| ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P850048/S027) | Beckman Coulter, Inc. | 2012-04-13 |
| HANCOCK II PORCINE BIOPROSTHESIS (P980043/S035) | Medtronic, Inc. | 2012-04-13 |
| VARIOUS FAMILIES OF EPIC, ATLAS, PROMOTE, UNIFY CRT-D'S (P030054/S218) | ABBOTT MEDICAL | 2012-04-13 |
| DEFIBRILLATOR/AUTOMATIC IMPLANTABLE CARDIOVERTER (P030054/S208) | ABBOTT MEDICAL | 2012-04-13 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P860057/S087) | Edwards Lifesciences, LLC | 2012-04-13 |
| 1X4 POCKET ADAPTOR KIT, 2X4 POCKET ADAPTOR KIT, ACTIVA SC, KINETRA, SOLETRA, INTERSTIM (P960009/S137) | Medtronic, Inc. | 2012-04-12 |
| FREEZOR CARDIAC CRYOABLATION CATHETERS, FREEZOR XTRA AND FREEZOR MAX SURGICAL CRYOABLATION DEVICES (P020045/S042) | Medtronic Cryocath, LP | 2012-04-12 |
| DERMAGRAFT (P000036/S009) | Shire Regenerative Medicine | 2012-04-12 |
| INTERSTIM (P080025/S027) | Medtronic Neuromodulation | 2012-04-12 |
| PRESILLION PLUS COCR CORONARY STENT RX SYSTEM (P110004) | Medinol, Ltd. | 2012-04-12 |
| INTERSTIM (P970004/S130) | Medtronic Neuromodulation | 2012-04-12 |
| ARCTIC FRONT CARDIAC CRYOABLATION CATHETER (P100010/S015) | Medtronic Cryocath, LP | 2012-04-12 |
| ARCHITECT HBSAG QUALITATIVE, QUALITATIVE CONFIRMATORY, CONFIRMATORY MANUAL DILUENT, CALIBRATORS, AND CONTROLS (P110029) | Abbott Laboratories | 2012-04-12 |
| POCKET ADAPTOR KIT, ITREL 3, SYNERGY & SYNERGY VERSITREL (P840001/S205) | Medtronic Neuromodulation | 2012-04-12 |
| DEFLUX (P000029/S072) | Palette Life Sciences | 2012-04-12 |
| SOLESTA (P100014/S007) | Palette Life Sciences | 2012-04-12 |
| ACRYSOF INTRAOCULAR LENSES (P930014/S061) | Alcon Laboratories, Inc. | 2012-04-11 |
| INCEPTA, ENERGEN AND PUNTUA CRT-DS (P010012/S285) | Boston Scientific Corp | 2012-04-11 |
| ALLEGRETTO WAVE EXCIMER LASER SYSTEMS (P020050/S007) | Alcon Laboratories, Inc. | 2012-04-11 |
| ACRYSOF RESTOR INTRAOCULAR LENSES (P040020/S041) | Alcon Research, Ltd. | 2012-04-11 |
| INCEPTA, ENERGEN AND PUNTUA IDCS (P960040/S255) | Boston Scientific | 2012-04-11 |
| ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEMS (P030008/S007) | Alcon Laboratories, Inc. | 2012-04-11 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S130) | Boston Scientific Corp | 2012-04-10 |
| PARADYM CRT (P060027/S032) | MicroPort CRM USA, Inc. | 2012-04-10 |
| PERCLOSE A T 6F & PERCLOSE PROGLIDE (PROGLIDE) (P960043/S077) | Abbott Vascular, Inc. | 2012-04-10 |
| S-SERIES LAMITRODE LEADS (P010032/S048) | ABBOTT MEDICAL | 2012-04-10 |
| PARADYM VR/DR (P980049/S065) | MicroPort CRM USA, Inc. | 2012-04-10 |
| INTERSTIM THERAPY SYSTEMS (P970004/S124) | Medtronic Neuromodulation | 2012-04-10 |
| GYNECAR INTERCEED ABSORBABLE ADHESION BARRIER (P880047/S019) | ETHICON, Inc. | 2012-04-10 |
| INTERSTIM THERAPY SYSTEMS (P080025/S016) | Medtronic Neuromodulation | 2012-04-10 |
| XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (P110019/S016) | Abbott Vascular | 2012-04-09 |
| THINPREP PROCESSOR 2000/3000 SYSTEM (P950039/S024) | Hologic, Inc. | 2012-04-09 |
| CAPSURE EPI (P950024/S037) | Medtronic, Inc. | 2012-04-06 |
| CAPSURE/SP/SP/Z NOVUS/VITATRON IMPULSE II/EXCELLENCE S+/IMPLUSE (P850089/S084) | Medtronic Cardiac Rhythm Disease Management | 2012-04-06 |
| CADENCE ICD SYSTEM (P910023/S287) | ABBOTT MEDICAL | 2012-04-06 |
| CAPSURE FIX NOVUS (P090013/S042) | Medtronic, Inc. | 2012-04-06 |
| CAPSURE VDD-2/CAPSURE BRILLIANT S+ (P890003/S237) | Medtronic, Inc. | 2012-04-06 |
| CAPSURE FIX NOVUS/SUREFIX/VITATRON CRYSTALLINE ACTFIX/PIROUET S+ (P930039/S063) | Medtronic, Inc. | 2012-04-06 |
| ATTAIN ABILITY (P080006/S035) | Medtronic, Inc. | 2012-04-06 |
| CAPSURE FIX (P980016/S325) | Medtronic Cardiac Rhythm Disease Management | 2012-04-06 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P100041/S002) | Edwards Lifesciences, LLC | 2012-04-06 |
| SPRINT QUATTRO SECURE /S/SPRINT (P920015/S083) | Medtronic, Inc. | 2012-04-06 |
| CAPSURE/SP NOVUS/VITATRON CRYSTALLINE/EXCELLENCE +/PS+ (P830061/S072) | Medtronic Cardiac Rhythm Disease Management | 2012-04-06 |
| ATTAIN OTW (P010015/S142) | Medtronic, Inc. | 2012-04-06 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S005) | Boston Scientific Corp | 2012-04-05 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S030) | Boston Scientific Corp | 2012-04-05 |
| AFP IMMULITE SUBSTRATE REAGENT (P010007/S008) | Siemens Healthcare Diagnostics, Inc. | 2012-04-05 |
| PSA IMMULITE SUBSTRATE REAGENT (P930027/S014) | Siemens Healthcare Diagnostics, Inc. | 2012-04-05 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (ALSO DISTRIBUTED AS PROMUS EECSS) (P070015/S086) | Abbott Vascular, Inc. | 2012-04-05 |
| FPSA IMMULITE SUBSTRATE REAGENT (P060005/S007) | Siemens Medical Solutions Diagnostics Limited | 2012-04-05 |
| MYNXGRIP VASCULAR CLOSURE DEVICE (P040044/S043) | Cordis US Corporation | 2012-04-05 |
| ONYX LIQUID EMBOLIC SYSTEM (P030004/S005) | Ev3 Neurovascular | 2012-04-05 |
| CARPENTIER-EDWARDS VALVED CONDUIT, MODEL 4300 (P870056/S047) | Edwards Lifesciences, LLC | 2012-04-04 |
| CLEAR-OPTIC AND ASPHERIC SURFACE INTRAOCULAR LENSES (P080004/S004) | Hoya Surgical Optics, Inc. | 2012-04-04 |
| MAXIMO VR ICD (P980016/S345) | Medtronic Cardiac Rhythm Disease Management | 2012-04-04 |
| ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT (P020018/S040) | Cook, Inc. | 2012-04-04 |
| THERAKOS CELLEX / PHOTOPHERESIS SYSTEMS (P860003/S064) | Therakos Development Limited | 2012-04-04 |
| CAPSUREFIX MRI LEAD (P090013/S058) | Medtronic, Inc. | 2012-04-04 |
| PARADIGM REAL-TIME INSULIN PUMP (P980022/S114) | Medtronic Minimed | 2012-04-04 |
| SEPRAFILM (P950034/S041) | Baxter Healthcare Corporation | 2012-04-04 |
| SELECTSECURE LEAD (P030036/S042) | Medtronic Cardiac Rhythm Disease Management | 2012-04-04 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S131) | Boston Scientific Corp | 2012-04-04 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S046) | W. L. Gore & Associates, Inc. | 2012-04-04 |
| AORTIC FRONT CARDIAC CRYOABLATION CATHETERS (P100010/S016) | Medtronic Cryocath, LP | 2012-04-04 |
| CONCERTO/CONCERTO II; CONSULTA; MAXIMO II; AND PROTECTA/PROTECTA XT (P010031/S232) | Medtronic Cardiac Rhythm Disease Management | 2012-04-04 |
| ADAPTA, ADAPTA L, ADAPTA S, SENSIA L, SENSIA VERSA IPG (P980035/S266) | Medtronic, Inc. | 2012-04-04 |
| CAPSUREFIX LEAD, CAPSUREFIX NOVUS LEAD & VITATRON CRYSTALLINE LEADS (P930039/S067) | Medtronic, Inc. | 2012-04-04 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHRONIUM CORONARY STENT SYSTEM (P110010/S008) | Boston Scientific Corp | 2012-04-03 |
| MULTI-LINK 8 CORONARY STENT SYSTEM (P020047/S042) | Abbott Vascular | 2012-04-03 |
| OPEN PIVOT AORTIC VALVED GRAFT (P990046/S027) | Medtronic Ats Medical, Inc. | 2012-04-03 |
| APLIGRAF (P950032/S068) | Organogenesis, Inc. | 2012-04-03 |
| INSYNC ICD MODEL 7272 (P010031/S297) | Medtronic Cardiac Rhythm Disease Management | 2012-04-02 |
| KAPPA 700 (P980035/S265) | Medtronic, Inc. | 2012-04-02 |
| INSYNC ICD MODEL 7272 (P010031/S295) | Medtronic Cardiac Rhythm Disease Management | 2012-04-02 |