| GAMBRO PRISMAFLEX TPE 2000 SET (P830063/S007) | Vantive US Healthcare, LLC | 2015-06-26 |
| SYNCHROMED INFUSION SYSTEM (P860004/S228) | Medtronic, Inc. | 2015-06-26 |
| RESOLUTE INTEGRITY ZOTAROLIMUS ELUTING CORONARY STENT SYSTEMS (P110013/S052) | Medtronic Vascular | 2015-06-26 |
| RESTORE,ITREL AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES,SPECIFY,AND VECTRIS SPINAL CORD STIMULATION LEADS (P840001/S303) | Medtronic Neuromodulation | 2015-06-26 |
| PROMUS ELEMENT PLUS/PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S109) | Boston Scientific Corp | 2015-06-26 |
| VERIFY EVALUATION SYSTEM FOR INTERSTIM THERAPY FOR URINARY CONTROL AND BOWEL CONTROL (P970004/S187) | Medtronic Neuromodulation | 2015-06-26 |
| ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S118) | Boston Scientific Corp | 2015-06-26 |
| PROGEL PLEURAL AIR LEAK SEALANT, PROGEL EXTENDED APPLICATOR SPRAY TIP16CM/6IN, PROGEL EXTENDED APPLICATOR SPRAY TIP29CM/ (P010047/S039) | Neomend, Inc. | 2015-06-26 |
| SYNCHROMED INFUSION SYSTEM (P860004/S229) | Medtronic, Inc. | 2015-06-26 |
| DIAMONDBACK 360 CORONARY ORIBITAL ATHERECTOMY SYSTEM (OAS) (P130005/S008) | Cardiovascular Systems, Inc. | 2015-06-25 |
| ATTAIN ABILITY LEAD (P080006/S082) | Medtronic, Inc. | 2015-06-25 |
| LCS TOTAL KNEE SYSTEM (P830055/S159) | Depuy, Inc. | 2015-06-25 |
| DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (OAS) (P130005/S009) | Cardiovascular Systems, Inc. | 2015-06-25 |
| VALIANT THORACIC STENT GRAFT WITH CAPTIVIA DELIVERY SYSTEM (P100040/S022) | Medtronic Vascular | 2015-06-25 |
| INTEGRA DERMAL REGENERATION TEMPLATE (P900033/S048) | Integra Lifesciences Corp. | 2015-06-25 |
| RAPID FFN FOR THE TLIIQ SYSTEM (P920048/S009) | Hologic, Inc. | 2015-06-24 |
| EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (P110023/S015) | Medtronic Vascular, Inc. | 2015-06-24 |
| AMS 700/AMBICOR INFLATABLE PENILE PROSTHESIS (IPP) (N970012/S109) | Boston Scientific Corp | 2015-06-24 |
| IN-PACT ADMIRAL PACLITAXEL-COATED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER (P140010/S006) | Medtronic, Inc. | 2015-06-24 |
| ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER (P010020/S033) | Boston Scientific Corp | 2015-06-24 |
| ENLITE SENSOR (P120010/S069) | Medtronic, Inc. | 2015-06-24 |
| AMS 800 URINARY CONTROL SYSTEM (P000053/S060) | Boston Scientific Corp | 2015-06-24 |
| ARISTA AH, ARISTA AH FLEXITIP/FLEXITIP XL/ FLEXITIP XL-R (P050038/S024) | Davol, Inc. | 2015-06-24 |
| MISAGO RX SELF-EXPANDING PERIPHERAL STENT (P140002/S001) | Terumo Medical Corporation | 2015-06-24 |
| PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S108) | Boston Scientific Corp | 2015-06-23 |
| ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P850048/S041) | Beckman Coulter, Inc. | 2015-06-23 |
| INTELLATIP MIFI XP TEMPERATURE ABLATION CATHETER (P020025/S074) | Boston Scientific | 2015-06-23 |
| ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P980041/S032) | Beckman Coulter, Inc. | 2015-06-23 |
| ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P090026/S015) | Beckman Coulter, Inc. | 2015-06-23 |
| NUCLEUS COCHLEAR IMPLANT SYSTEM (P970051/S129) | Cochlear Americas | 2015-06-23 |
| ION PACLITAXEL ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S117) | Boston Scientific Corp | 2015-06-23 |
| ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P970038/S031) | Beckman Coulter, Inc. | 2015-06-23 |
| ANIMAS VIBE SYSTEM (P130007/S002) | Animas Corp. | 2015-06-22 |
| CAPSUREFIX NOVUS MRI SURESCAN LEAD MODEL 5076 (P930039/S130) | Medtronic, Inc. | 2015-06-22 |
| ADVISA SR IPG (P980035/S424) | Medtronic, Inc. | 2015-06-22 |
| DYNAGEN, INOGEN, ORIGEN, PUNCTUA, ENERGEN, INCEPTA ICD'S (P010012/S389) | Boston Scientific Corp | 2015-06-22 |
| IMPLANTABLE MULTI-PROGRAMMABLE QUADRIPOLAR DEEP BRAIN STIMULATION SYSTEM (P960009/S169) | Medtronic, Inc. | 2015-06-22 |
| ENTOVIS DR, ENTOVIS DR-T, ENTOVIS SR, ENTOVIS SR-T, EVIA DR, EVIA DR-T, EVIA SR,EVIA SR-T, ESTELLA DR, ESTELLA DR-T, EST (P950037/S155) | Biotronik, Inc. | 2015-06-22 |
| DYNAGEN, INOGEN, ORIGEN, PUNCTUA, ENERGEN, INCEPTA CRT-D (P960040/S347) | Boston Scientific | 2015-06-22 |
| COREVALVE (TM) EVOLUT(TM) R SYSTEM (P130021/S014) | Medtronic, Inc. | 2015-06-22 |
| ELUNA 8 HF-T,ETRINSA 8 HF-T, EPYRA 8 HF-T,EVIA HF-T,STRATOS LV,COROX OTW 75-BP,COROX OTW 85BP,COROX OTW-S 75-BP,COROX OT (P070008/S066) | Biotronik, Inc. | 2015-06-22 |
| IPERIA 7 VR-T (DF-1),IPERIA 7 VR-T (DF-4),ITREVIA 7 VR-T (DF-1),ITREVIA 7 VR-T (DF-4),INVENTRA 7 VR-T (DF-1),INVENTRA 7 (P050023/S092) | Biotronik, Inc. | 2015-06-22 |
| LINOX SMART SD 60/16,LINOX SMART SD 65/16,LINOX SMART SD 65/18,LINOX SMART SD 75/18,LINOX SMART TD 65/16,LINOX SMART TD (P980023/S068) | Biotronik, Inc. | 2015-06-22 |
| INVENTRA CRT-D (P050023/S085) | Biotronik, Inc. | 2015-06-19 |
| ON-X PROSTHETIC HEART VALVE (P000037/S041) | On-X Life Technologies, Inc. | 2015-06-19 |
| IN PACT ADMIRAL PACLITAXEL-COATING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER (P140010/S002) | Medtronic, Inc. | 2015-06-19 |
| TRANSCEND HIP ARTICULATION SYSTEM (P010001/S013) | Ceramtec GmbH | 2015-06-19 |
| PHYLAX AV ICD SYSTEM (P000009/S062) | Biotronik, Inc. | 2015-06-19 |
| STRATOS LV/LV-T CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRP-T) SYSTME (P070008/S062) | Biotronik, Inc. | 2015-06-19 |
| ESTEEM (P090018/S029) | Envoy Medical Corporation | 2015-06-19 |
| DROMOS DRISK RATE ADAPTIVE PACEING SYSTEM (P950037/S150) | Biotronik, Inc. | 2015-06-19 |
| ROTAWIRE ELITE GUIDEWIRE (P900056/S145) | Boston Scientific Corp | 2015-06-19 |
| IN.PACT ADMIRAL PACLITAXEL-COATING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER (P140010/S003) | Medtronic, Inc. | 2015-06-19 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (P130009/S036) | Edwards Lifesciences, LLC | 2015-06-18 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTH (P860057/S137) | Edwards Lifesciences, LLC | 2015-06-18 |
| HEPARIN-INDUCED EXTRACORPOREAL LDL PRECIPITATION (H.E.L.P.) FUTURA APHERESIS SYSTEM (P940016/S019) | B. Braun Avitum AG | 2015-06-18 |
| EDWARDS EXPANDABLE INTRODUCER SHEATH SET (P130009/S035) | Edwards Lifesciences, LLC | 2015-06-17 |
| IMPELLA 2.5 SYSTEM (P140003/S002) | Abiomed, Inc. | 2015-06-17 |
| AFX ENDOVASCULAR AAA SYSTEM (P040002/S054) | Endologix, LLC | 2015-06-17 |
| SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES (P140031) | Edwards Lifesciences, LLC | 2015-06-17 |
| PROGEL PLEURAL AIR LEAK SEALANT (P010047/S034) | Neomend, Inc. | 2015-06-17 |
| ADVISA DR IPG, ADVISA DR MRI IPG,AND ADVISA SR MRI IPG (P980035/S425) | Medtronic, Inc. | 2015-06-16 |
| HEPARIN-INDUCED EXTRACORPOREAL LDL-PRECIPITATION (H.E.L.P.) FUTURA APHERESIS SYSTEM (P940016/S018) | B. Braun Avitum AG | 2015-06-16 |
| SMARTABLATE SYSTEM (P990071/S031) | Biosense Webster, Inc. | 2015-06-16 |
| ANGIO-SEAL VASCULAR CLOSURE DEVICE (P930038/S074) | Terumo Medical Corporation | 2015-06-16 |
| CAPSUREFIX LEAD (P930039/S132) | Medtronic, Inc. | 2015-06-16 |
| REVO MRI SURESCAN IPG (P090013/S187) | Medtronic, Inc. | 2015-06-16 |
| CONSULTA CRT-P, SYNCRA CRT-P AND VIVA CRT-P (P010015/S273) | Medtronic, Inc. | 2015-06-16 |
| NOVASURE IMPEDENCE CONTROLLED ABLATION SYSTEM (P010013/S063) | Hologic, Inc. | 2015-06-15 |
| NUCLEUS CI522 COCHLEAR IMPLANT SYSTEM (P970051/S126) | Cochlear Americas | 2015-06-15 |
| RESQCPR SYSTEM (P110024/S001) | ZOLL Medical Corporation | 2015-06-15 |
| HEPARIN-INDUCED EXTRACORPOREAL LDL PRECIPITATION (H.E.L.P.)FUTURA APHERESIS SYSTEM (P940016/S017) | B. Braun Avitum AG | 2015-06-15 |
| BD PREPMATE SLIDE PROCESSOR, BD PREPMATE AUTOMATED ACCESSORY (P970018/S031) | Bd Diagnostic Systems | 2015-06-14 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S051) | Medtronic Vascular | 2015-06-12 |
| INTELLATIP MIFI XP TEMPERATURE ABLATION CATHETER (P020025/S072) | Boston Scientific | 2015-06-12 |
| INTEGRITY CORONARY STENT SYSTEMS (P030009/S081) | Medtronic, Ireland | 2015-06-12 |
| EVIA HF, EVIA HF-T, ENTOVIS HF, ENTOVIS HF-T (P070008/S065) | Biotronik, Inc. | 2015-06-12 |
| VENTANA ALK (D5F3) CDX ASSAY (P140025) | Ventana Medical Systems, Inc. | 2015-06-12 |
| ROTOBLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S147) | Boston Scientific Corp | 2015-06-12 |
| LINOX SMART SD 60/16,LINOX SMART SD 65/16,LINOX SMART SD 65/18,LINOX SMART SD 75/18,LINOX SMART TD 65/16, LINOX SMART TD (P980023/S067) | Biotronik, Inc. | 2015-06-12 |
| ILESTO 7 HF-T, ILESTO 5 HF-T, IFORIA 7 HF-T IFORIA 5 HF-T, INVENTRA 7 HF-T (DF-1), INVENTRA 7 HF-T (DF4), IPERIA 7HF-T ( (P050023/S091) | Biotronik, Inc. | 2015-06-12 |
| EVIA DR, EVIA DR-T, EVIA SR, EVIA SR-T, ENTOVIS DR, ENTOVIS DR-T, ENTOVIS SR, ENTOVIS SR-T, ESTELLA DR, ESTELLA DR-T, ES (P950037/S154) | Biotronik, Inc. | 2015-06-12 |
| BRIO NEUROSTIMULATION SYSTEM (P140009) | ABBOTT MEDICAL | 2015-06-12 |
| CARPENTIER-EDWARDS PERIMOUNT AORTIC & MITRAL BIOPROSTHESIS FAMILIES (P860057/S135) | Edwards Lifesciences, LLC | 2015-06-11 |
| GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P130006/S019) | W. L. Gore & Associates, Inc. | 2015-06-11 |
| GORE HELEX SEPTAL OCCLUDER, GORE CARDIOFORM SEPTAL OCCLUDER (P050006/S047) | W. L. Gore & Associates, Inc. | 2015-06-11 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S080) | W. L. Gore & Associates, Inc. | 2015-06-11 |
| ELECSYS ANTI-HCV II IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV (P140021) | Roche Diagnostics Operations, Inc. | 2015-06-11 |
| PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S227) | Boston Scientific Corp | 2015-06-11 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S044) | W. L. Gore & Associates, Inc. | 2015-06-11 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S116) | W. L. Gore & Associates, Inc. | 2015-06-11 |
| TRANSCEND HIP ARTICULATION SYSTEM (P010001/S012) | Ceramtec GmbH | 2015-06-11 |
| ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S228) | Medtronic, Inc. | 2015-06-11 |
| ACTIVL ARTIFICIAL DISC (P120024) | Highridge Medical, LLC | 2015-06-11 |
| RESTORE, ITREL, & SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES, SPECIFY, AND VECTRIS SPINAL CORD STIMULATION LEAD (P840001/S302) | Medtronic Neuromodulation | 2015-06-11 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S074) | W. L. Gore & Associates, Inc. | 2015-06-11 |
| ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S116) | Boston Scientific Corp | 2015-06-11 |
| PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S107) | Boston Scientific Corp | 2015-06-11 |
| JUVEDERM VOLUMA XC (P110033/S016) | Allergan | 2015-06-10 |
| SUPERA PERIPHERAL STENT SYSTEM (P120020/S010) | Abbott Vascular (Idef Technologies Inc) | 2015-06-10 |