| DURAFLEX LOW PRESSURE PORCINE MITRAL BIOPROSTHESIS, DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS WITH EXTENDED SUTURE RING (P870077/S053) | Edwards Lifesciences, LLC | 2013-04-24 |
| CARPENTIER-EDWARDS S.A.V. AORTIC PORCINE BIOPROSTHESIS (P010041/S042) | Edwards Lifesciences, LLC | 2013-04-24 |
| ZENITH AAA ENDOVASCULAR GRAFT (P020018/S049) | Cook, Inc. | 2013-04-24 |
| AMVISC AND AMVISC PLUS OPHTHALMIC VISCOSURICAL DEVICE (OVD) (P810025/S033) | Bausch & Lomb, Inc. | 2013-04-24 |
| PORCINE AORTIC BIOPROTHESIS AND PORCINE MITRAL BIOPROSTHESIS (P870056/S058) | Edwards Lifesciences, LLC | 2013-04-24 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS (P860057/S107) | Edwards Lifesciences, LLC | 2013-04-24 |
| EDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROSTHESIS (P000007/S040) | Edwards Lifesciences, LLC | 2013-04-24 |
| PROGEL PLEURAL AIR LEAK SEALANT (P010047/S029) | Neomend, Inc. | 2013-04-24 |
| TRANSCATHETER HEART VALVE (P110021/S009) | Edwards Lifesciences, LLC | 2013-04-24 |
| RADIESSE INJECTABLE IMPLANT (P050052/S039) | Merz North America, Inc. | 2013-04-23 |
| COFLEX® INTERLAMINAR TECHNOLOGY (P110008/S001) | Companion Spine France | 2013-04-23 |
| ATLAS/ATLAS+, ATLAS II/ATLAS II+, CURRENT, CURRENT ACCEL, CURRENT+, EPIC/EPIC+, EPIC II/EPIC II+, FORTIFY (P910023/S312) | ABBOTT MEDICAL | 2013-04-23 |
| HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM (P100047/S010) | Medtronic | 2013-04-23 |
| COFLEX® INTERLAMINAR TECHNOLOGY (P110008/S002) | Companion Spine France | 2013-04-23 |
| SURGICEL FAMILY OF ABSORBABLE HEMOSTATS (N12159/S031) | ETHICON, Inc. | 2013-04-23 |
| IDENTIFY, VERITY, VICTORY, ZEPHYR, ACCENT FAMILY OF PACEMAKER DEVICES (P880086/S231) | ABBOTT MEDICAL | 2013-04-23 |
| RADIESSE INJECTABLE IMPLANT (P050037/S036) | Merz North America, Inc. | 2013-04-23 |
| FRONTIER, FRONTIER II, ANTHEM FAMILY OF CRT-P DEVICES (P030035/S109) | ABBOTT MEDICAL | 2013-04-23 |
| ATLAS+ HF/ATLAS II HF, ATLAS II+ HF, EPIC+, EPIC II HF, EPIC II+HF, PROMOTE, PROMOTE+, PROMOTE, RF, PROMOTE ACCEL, UNIFY (P030054/S242) | ABBOTT MEDICAL | 2013-04-23 |
| LIFESTENT VASCULAR STENT SYSTEMS (P070014/S038) | Bard Peripheral Vascular, Inc. | 2013-04-22 |
| BARD E-LUMINEXX VASCULAR STENT SYSTEM (P080007/S016) | Bard Peripheral Vascular, Inc. | 2013-04-22 |
| FLAIR ENDOVASCULAR STENT GRAFT (P060002/S030) | Bard Peripheral Vascular | 2013-04-22 |
| OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM (P120006/S003) | Endologix, LLC | 2013-04-21 |
| INCEPTA, ENERGEN, AND PUNCTUA MODELS OF ICD¿S (P960040/S289) | Boston Scientific | 2013-04-19 |
| PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM (P080012/S012) | Infusyn Therapeutics, LLC | 2013-04-19 |
| HER2 CISH PHARMDX KIT (P100024/S004) | Dako Denmark A/S | 2013-04-19 |
| INCEPTA, ENERGEN, AND PUNCTUA MODELS OF CRT¿S (P010012/S324) | Boston Scientific Corp | 2013-04-19 |
| 6947M SPRINT QUATTRO LEAD (P920015/S105) | Medtronic, Inc. | 2013-04-18 |
| HERCEPTEST (P980018/S017) | Agilent Technologies Singapore (International) Pte , Ltd. | 2013-04-18 |
| 3830 SELECTSECURE LEAD (P030036/S054) | Medtronic Cardiac Rhythm Disease Management | 2013-04-18 |
| ATTAIN STARFIX LEAD (P060039/S042) | Medtronic, Inc. | 2013-04-18 |
| CAPSURE LEAD, CAPSURE SENSE BIPOLAR LEAD, VITATRON CRYSTALINE LEAD, VITATRON EXCELLENCE PS+ LEAD (P830061/S087) | Medtronic Cardiac Rhythm Disease Management | 2013-04-18 |
| WALLSTENT (ILIAC) ENDOPROSTHESIS (P940019/S036) | Boston Scientific Scimed, Inc. | 2013-04-18 |
| BLAZERII TEMPERATURE ABLATION CATHETER, BLAZERII XP TEMPERATURE ABLATION CATHETER, BLAZER PRIME HTD TEMPERATURE ABLATION (P020025/S040) | Boston Scientific | 2013-04-18 |
| MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD (P980016/S405) | Medtronic Cardiac Rhythm Disease Management | 2013-04-18 |
| CERVISTA HPV HR, GENFIND DNA EXTRACTION KIT (P080014/S015) | Hologic, Inc. | 2013-04-18 |
| EPT-1000 CARDIAC ABLATION SYSTEM (P920047/S057) | Boston Scientific Corp | 2013-04-18 |
| CAPSUREFIX NOVUS LEAD, VITATRON CRYSTALLINE LEAD (P930039/S083) | Medtronic, Inc. | 2013-04-18 |
| GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P040037/S046) | W. L. Gore & Associates, Inc. | 2013-04-18 |
| WALLSTENT (TIPS) ENDOPROSTHESIS (P930031/S042) | Boston Scientific Corp | 2013-04-18 |
| EPIC VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S011) | Boston Scientific Corp | 2013-04-18 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P110021/S010) | Edwards Lifesciences, LLC | 2013-04-18 |
| CAPSURE SP NOVUS LEAD, CAPSURE Z NOVUS LEAD, IMPULSE II LEAD (P850089/S093) | Medtronic Cardiac Rhythm Disease Management | 2013-04-18 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P100041/S024) | Edwards Lifesciences, LLC | 2013-04-18 |
| ATTAIN ABILITY LEAD (P080006/S050) | Medtronic, Inc. | 2013-04-18 |
| CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D (P010031/S368) | Medtronic Cardiac Rhythm Disease Management | 2013-04-18 |
| BI-DIRECTIONAL THERAPY COOL PATH DUO IRRIGATED ABLATION CATHETERS (P110016/S006) | ABBOTT MEDICAL | 2013-04-18 |
| WALLSTENT (VENOUS) ENDOPROSTHESIS (P980033/S031) | Boston Scientific Corporation | 2013-04-18 |
| ACRYSOF INTRAOCULAR LENSES (P930014/S067) | Alcon Laboratories, Inc. | 2013-04-17 |
| VYSIS ALK BREAK APART FISH PROBE KIT AND PROBECHEK ALK NEGATIVE CONTROL SLIDES (P110012/S003) | Abbott Molecular, Inc. | 2013-04-17 |
| PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S159) | Boston Scientific Corp | 2013-04-17 |
| INTERSTIM II NEUROSTIMULATOR (P970004/S154) | Medtronic Neuromodulation | 2013-04-17 |
| ACTIVA PC NEUROSTIMULATOR, ACTIVA SC NEUROSTIMULATOR, ACTIVA SC NEUROSTIMULATOR, ACTIVA RC NEUROSTIMULATOR (P960009/S168) | Medtronic, Inc. | 2013-04-17 |
| SYNCHROMED II INFUSION PUMP (P860004/S190) | Medtronic, Inc. | 2013-04-17 |
| RESTOREPRIME NEUROSTIMULATOR, PRIMEADVANCED NEUROSTIMULATOR, ITREL 4 PROGRAMMABLE NEUROSTIMULATOR FOR SPINAL CORD (P840001/S237) | Medtronic Neuromodulation | 2013-04-17 |
| ACRYSOF RESTOR INTRAOCULAR LENSES (P040020/S046) | Alcon Research, Ltd. | 2013-04-17 |
| NOVOTTF-100A SYSTEM (P100034/S003) | Novocure, GmbH | 2013-04-17 |
| INTERSTIM II NEUROSTIMULATOR (P080025/S050) | Medtronic Neuromodulation | 2013-04-17 |
| LINX REFLUX MANAGEMENT SYSTEM (P100049/S005) | Torax Medical | 2013-04-17 |
| POWERLINK SYSTEM WITH INTUITRAK DELIVERY SYSTEM (P040002/S039) | Endologix, LLC | 2013-04-16 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S041) | Zoll Manufacturing Corporation | 2013-04-16 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROTHESIS (P860057/S106) | Edwards Lifesciences, LLC | 2013-04-16 |
| ENDURANT II AUI STENT GRAFT SYSTEM (P100021/S021) | Medtronic Vascular | 2013-04-16 |
| PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S158) | Boston Scientific Corp | 2013-04-16 |
| ANGIO-SEAL VASCULAR CLOSURE DEVICE (P930038/S067) | Terumo Medical Corporation | 2013-04-15 |
| TECNIS TORIC 1-PEICE INTRAOCULAR LENS (P980040/S039) | Johnson & Johnson Surgical Vision, Inc. | 2013-04-15 |
| PERCLOSE PROGLIDE SUTURE MEDIATED CLOSURE SYSTEM (P960043/S080) | Abbott Vascular, Inc. | 2013-04-15 |
| WAVELIGHT EX 500 LASER SYSTEM (P030008/S010) | Alcon Laboratories, Inc. | 2013-04-12 |
| INTEGRITY CORONARY STENT SYSTEMS (P030009/S063) | Medtronic, Ireland | 2013-04-12 |
| MODEL 5019 HV SPLITTER/ADAPTOR (P920015/S106) | Medtronic, Inc. | 2013-04-12 |
| WAVELIGHT EX500 LASER SYSTEM, ALLEGRO ANALYZER (P020050/S011) | Alcon Laboratories, Inc. | 2013-04-12 |
| THERMOCOOL SF CATHETERS (P990071/S018) | Biosense Webster, Inc. | 2013-04-12 |
| LIFESTENT VASCULAR STENT SYSTEMS (P070014/S036) | Bard Peripheral Vascular, Inc. | 2013-04-12 |
| VNS THERAPY SYSTEM (P970003/S160) | LivaNova USA, Inc. | 2013-04-12 |
| PUNCTUA, COGNIS, ENERGEN, AND INCEPTA CRT-DS (P010012/S326) | Boston Scientific Corp | 2013-04-12 |
| CELSIUS DS, NAVISTAR DS,NAVISTAR RMT DS, EZ STEER NAV DS CATHETERS (P010068/S028) | Biosense Webster, Inc. | 2013-04-12 |
| CELSIUS THERMOCOOL, CELSIUS RMT THERMOCOOL, NAVISTAR THERMOCOOL, NAVISTAR RMT THERMOCOOL CATHETERS (P030031/S042) | Biosense Webster, Inc. | 2013-04-12 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S009) | Medtronic Vascular | 2013-04-12 |
| PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S160) | Boston Scientific Corp | 2013-04-12 |
| CELSIUS, CELSIUS RMT, EZ STEER, EZ STEER DS CATHETERS (P950005/S038) | Biosense Webster, Inc. | 2013-04-12 |
| E-LUMINEXX VASCULAR STENT (P080007/S015) | Bard Peripheral Vascular, Inc. | 2013-04-12 |
| NAVISTAR, NAVISTAR RMT, EZ STEER NAV CATHETERS (P990025/S032) | Biosense Webster, Inc. | 2013-04-12 |
| PUNCTUA, TELIGEN, ENERGEN AND INCEPTA ICDS (P960040/S291) | Boston Scientific | 2013-04-12 |
| LCS TOTAL KNEE SYSTEM (P830055/S133) | Depuy, Inc. | 2013-04-12 |
| NAVISTAR THERMOCOOL, NAVISTAR RMT THERMOCOOL, EZ STEER THERMOCOOL, EZ STEER THERMOCOOL NAV CATHETERS (P040036/S031) | Biosense Webster, Inc. | 2013-04-12 |
| REVO MRI IPG (P090013/S090) | Medtronic, Inc. | 2013-04-11 |
| CAPSUREFIX LEAD, APSUREFIX NOVUS LEAD, SUREFIX LEAD, VITATRON CRYSTALLINE LEAD (P930039/S084) | Medtronic, Inc. | 2013-04-11 |
| DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S004) | Dexcom, Inc. | 2013-04-11 |
| ATTAIN BIPOLAR OTW LEAD, LEFT VENTRICULAR PACING LEAD (P010015/S195) | Medtronic, Inc. | 2013-04-11 |
| CAPSURE SP NOVUS LEAD, CAPSURE Z NOVUS LEAD, EXCELLENCE SS+ LEAD, IMPULSE II LEAD (P850089/S094) | Medtronic Cardiac Rhythm Disease Management | 2013-04-11 |
| ATTAIN ABILITY LEAD (P080006/S051) | Medtronic, Inc. | 2013-04-11 |
| END CAP, SIZING SLEEVE, UPSIZING SLEEVE (P900061/S119) | Medtronic Cardiac Rhythm Disease Management | 2013-04-11 |
| ATTAIN STARFIX LEAD (P060039/S043) | Medtronic, Inc. | 2013-04-11 |
| CAPSURE LEAD, SERVICE KIT-PACEMAKER REPAIR KIT (P890003/S271) | Medtronic, Inc. | 2013-04-11 |
| ANCHORING SLEEVE KIT, SELECTSECURE LEAD (P030036/S055) | Medtronic Cardiac Rhythm Disease Management | 2013-04-11 |
| RF CONDUCTR 5 MM (7FR, 8FR TIP), RF CONDUCTR 4 MM (7FR), RF CONTACTR 5 MM (7FR, 8FR TIP), RF CONTACTR 5 MM (7FR, 8FR TIP (P930029/S039) | Medtronic, Inc. | 2013-04-11 |
| SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM (P110042/S006) | Boston Scientific Corporation | 2013-04-11 |
| EON NEUROSTIMULATION SYSTEM, EON MINI NEUROSTIMULATION SYSTEM, 3788 AND EON NEUROSTIMULATION SYSTEM, 3688 (P010032/S063) | ABBOTT MEDICAL | 2013-04-11 |
| ADVISA DR IPG,ADVISA DR MRI IPG (P980035/S316) | Medtronic, Inc. | 2013-04-11 |
| CAPSURE EPICARDIAL PACING LEAD (P950024/S047) | Medtronic, Inc. | 2013-04-11 |