| THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER (P040036/S052) | Biosense Webster, Inc. | 2015-08-18 |
| SELECTSECURE LEAD (P030036/S079) | Medtronic Cardiac Rhythm Disease Management | 2015-08-18 |
| CONSULTA CRT-P,SYNCRA CRT-P,VIVA CRT-P (P010015/S276) | Medtronic, Inc. | 2015-08-18 |
| CAPSUREFIX LEAD (P930039/S136) | Medtronic, Inc. | 2015-08-18 |
| ADVISA DR IPG, ADVISA DR MRI IPG,ADVISA SR MRI IPG (P980035/S433) | Medtronic, Inc. | 2015-08-18 |
| CELSIUS FLTR BI-DIRECTIONAL CATHETER (P010068/S048) | Biosense Webster, Inc. | 2015-08-18 |
| CELSIUS FLTR UNI -DIRECTIONAL CATHETER (P950005/S058) | Biosense Webster, Inc. | 2015-08-18 |
| ACTIVITRAX, ACTIVITRAX II, LEGEND, LEGEND II, MICRO MINIX, MINIX, MINIX ST, PREMIER, PREVAIL,VITATRON LEGACY SR (P850051/S084) | Medtronic, Inc. | 2015-08-17 |
| ENTRUST, GEMFAMILY, INTRINSCI, MARGUIS, MAXIMO FAMILY, ONYX, PROTECTA FAMILY,SECURA FAMILY,VITITUSO, EVERA FAMILY (P980016/S541) | Medtronic Cardiac Rhythm Disease Management | 2015-08-17 |
| REVO MRI, ENRHYTHM MRI (P090013/S193) | Medtronic, Inc. | 2015-08-17 |
| ADAPTA, ADVISA, AT500, ENPULSE, ENRHYTHM, KAPPA 600,KAPPA 650,KAPPA 700,KAPPA 800,KAPPA 900, RELIA,SENSIA,SIGMA, VERSA (P980035/S431) | Medtronic, Inc. | 2015-08-17 |
| KAPPA 400 (P970012/S098) | Medtronic, Inc. | 2015-08-17 |
| GEM, JEWEL, MICRO JEWEL, JEWEL PLUS, MICRO JEWEL II PCD (P900061/S136) | Medtronic Cardiac Rhythm Disease Management | 2015-08-17 |
| ELITE &II, MINUET,PREVA PREVA D PRODIGY SYNERGYST II,THERA &I, , VITATRON LEGACY, VITATRON LEGAACY,REVEAL (P890003/S333) | Medtronic, Inc. | 2015-08-17 |
| DIVA AND DEMA FAMILIES PULSE GNERATORS (P990001/S121) | Medtronic, Inc. | 2015-08-17 |
| LEGEND PLUS (P930022/S019) | Medtronic, Inc. | 2015-08-17 |
| CONCERTO, INSYNC, MACIMO, PROTECTA AND VIVA FAMILIES AND BRAVA CRTS-D'S (P010031/S505) | Medtronic Cardiac Rhythm Disease Management | 2015-08-17 |
| JEWEL AF, GEM III AT (P980050/S101) | Medtronic, Inc. | 2015-08-17 |
| CONSULTA CRT-P, INSYNC, INSYNC III, SYNCRA CRT-P, VIVA CRT-P (P010015/S275) | Medtronic, Inc. | 2015-08-17 |
| PASYS, PASYS ST, SPECTRAX S, SPECTRAX SX, SPECTRAX SX-HT, SPECTRAX SXT, SYSMBIOS, SYNERGYST (P820003/S135) | Medtronic Cardiac Rhythm Disease Management | 2015-08-17 |
| PCD (P920015/S159) | Medtronic, Inc. | 2015-08-17 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S075) | W. L. Gore & Associates, Inc. | 2015-08-14 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S045) | W. L. Gore & Associates, Inc. | 2015-08-14 |
| GORE VIABAHN ENDOPROSTHESIS (P130006/S024) | W. L. Gore & Associates, Inc. | 2015-08-14 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S120) | W. L. Gore & Associates, Inc. | 2015-08-14 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S085) | W. L. Gore & Associates, Inc. | 2015-08-14 |
| AMPLATZER SEPTAL DEFECT OCCLUDER (P000039/S050) | ABBOTT MEDICAL | 2015-08-14 |
| QUICKSITE, QUICKFLEX, AND QUICKFLEX LEADS (P030054/S150) | ABBOTT MEDICAL | 2015-08-13 |
| TENDRIL, TENDRIL ST, TENDRIL STS, AND OPTISENSE LEADS (P960013/S061) | ABBOTT MEDICAL | 2015-08-13 |
| ZILVER VASCULAR STENT (P050017/S011) | Cook Ireland, Ltd. | 2015-08-13 |
| PASSIVE PLUS, ISOFLEX S&P, AND ISOFLEX OPTIM LEADS (P960030/S031) | ABBOTT MEDICAL | 2015-08-13 |
| ZILVER PTX DRUG-ELUTING PERIPHERAL STENT (P100022/S015) | Cook Ireland, Ltd. | 2015-08-13 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S053) | Medtronic Vascular | 2015-08-12 |
| WALLSTENT ENDOPROSTHESIS TIPS (P930031/S054) | Boston Scientific Corp | 2015-08-12 |
| EXPRESS LD ILIAC PREMOUNTED SYSTEM (P090003/S037) | Boston Scientific Corporation | 2015-08-12 |
| WALLSTENT VENOUS ENDOPROSTHESIS (P980033/S043) | Boston Scientific Corporation | 2015-08-12 |
| VERIFLEX (LIBERTE) BARE-METAL CORONARY STENT SYSTEM (P040016/S134) | Boston Scientific Scimed, Inc. | 2015-08-12 |
| EXPRESS SD RENAL MONORAIL PREMOUNTED SYSTEM (P060006/S064) | Boston Scientific Corp | 2015-08-12 |
| VALITUDE CRT-P (P030005/S128) | Guidant Corp. | 2015-08-08 |
| ESSENTIO, PROPONENT, ACCOLADE, ALTRUA 2 (N970003/S181) | Boston Scientific Corp | 2015-08-08 |
| INCEPTA, ENERGEN,PUNCTUA, DYNAGEN, INOGEN, ORIGEN ICD'S (P960040/S352) | Boston Scientific | 2015-08-08 |
| INCEPTA, ENERGEN, PUNCTUA, DYNAGEN,INOGEN,ORIGEN CRT-D (P010012/S396) | Boston Scientific Corp | 2015-08-08 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS; THEON PERICARDIAL AORTIC BIOPROSTHESIS WITH THERMALFIX TI (P860057/S138) | Edwards Lifesciences, LLC | 2015-08-07 |
| ENDURANT STENT GRAFT SYSTEM, ENDURANT II STENT GRAFT SYSTEM, ENDURANT II AORTO-UNI-LLIAC(AUI) STENT GRAFT SYSTEM, ENDURA (P100021/S048) | Medtronic Vascular | 2015-08-07 |
| EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (P140031/S001) | Edwards Lifesciences, LLC | 2015-08-07 |
| OVATION ABDOMINAL STENT GRAFT SYSTEM, OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM, OVATION IX ILIAC STENT GRAFT (P120006/S021) | Endologix, LLC | 2015-08-07 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (P130009/S040) | Edwards Lifesciences, LLC | 2015-08-07 |
| ASCENDRA + DELIVERY SYSTEM (P130009/S039) | Edwards Lifesciences, LLC | 2015-08-07 |
| THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER (P030031/S069) | Biosense Webster, Inc. | 2015-08-06 |
| THERMOCOOK SMARTTOUCH UNI-DIRECTIONAL NAVIGATION CATHETER (P040036/S051) | Biosense Webster, Inc. | 2015-08-06 |
| GORE VIABAHN ENDOPROSTHESIS,GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P130006/S023) | W. L. Gore & Associates, Inc. | 2015-08-04 |
| GORE VIABAHN ENDOPROSTHESIS, GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P040037/S084) | W. L. Gore & Associates, Inc. | 2015-08-04 |
| MYNXGRIP VASCULAR CLOSURE DEVICES (P040044/S059) | Cordis US Corporation | 2015-08-03 |
| MYNX ACE VASCULAR CLOSURE DEVICE (P040044/S065) | Cordis US Corporation | 2015-08-03 |
| ZENITH TX2 TAA ENDOVASCULAR GRAFT (P070016/S010) | William Cook Europe Aps | 2015-08-03 |
| ENROUTE TRANSCAROTID STENT SYSTEM (P140026/S001) | Boston Scientific Corporation | 2015-08-03 |
| MEDTRONIC COREVALVE (R) SYSTEM (P130021/S013) | Medtronic, Inc. | 2015-08-03 |
| DYNAGEN, INOGEN, ORIGEN, CRT-D DEVICES (P010012/S394) | Boston Scientific Corp | 2015-07-31 |
| PARADYM CRT-D 8750, PARADYM RF CRT-D9750 (ZL101), PARADYM RF CRT-D9750 (ZL102), INTENSIA CRT-D 174 (P060027/S078) | MicroPort CRM USA, Inc. | 2015-07-31 |
| ADVISA DR IPG, ADVISA DR MRI IPG, ADVISA SR MRI IPG (P980035/S432) | Medtronic, Inc. | 2015-07-31 |
| PARADYM RF CRT-D9750 (ZL101) & (ZL102) ; INTENSIA CRT-D 174 (P060027/S077) | MicroPort CRM USA, Inc. | 2015-07-31 |
| PARADYM RF VR 9750, PARADYM RF DR 9750 (ZL 101) & (ZL102) (P980049/S111) | MicroPort CRM USA, Inc. | 2015-07-31 |
| REVO MRI SURESCAN IPG (P090013/S194) | Medtronic, Inc. | 2015-07-31 |
| PARADYM VR 8750, PARADYM DR 8750, PARADYM RF VR 9750, PARADYM RF DR 9750 (ZL101), PARADYM RF VR 9750, PARADYM RF DR 9750 (P980049/S112) | MicroPort CRM USA, Inc. | 2015-07-31 |
| SMART AND SMART CONTROL NITINOL STENT SYSTEM (P020036/S031) | Cordis US Corporation | 2015-07-31 |
| ARCTIC FRONT ADVANCE ST (P100010/S050) | Medtronic Cryocath, LP | 2015-07-31 |
| DYNAGEN, INOGEN, ORIGEN ICD DEVICES (P960040/S350) | Boston Scientific | 2015-07-31 |
| PARADYM VR 8750,PARADYM DR 8750,PARADYM RF VR 9750,PARADYM RF DR 9750(ZL101,ZL102)) (P980049/S110) | MicroPort CRM USA, Inc. | 2015-07-31 |
| SMART AND SMART CONTROL VASCULAR STENT SYSTEM (P120002/S006) | Cordis US Corporation | 2015-07-31 |
| SPRINT QUATTRO LEAD (P920015/S160) | Medtronic, Inc. | 2015-07-31 |
| REPLY SR, REPLY DR, ESPRIT SR, ESPRIT DR (P950029/S107) | MicroPort CRM USA, Inc. | 2015-07-31 |
| PARADYM CRT-D 8750,PARADYM RF CRT-D 9750(ZL101),PARADYM RF CRT-D 9750 (ZL102),INTENSIA CRT-D (P060027/S076) | MicroPort CRM USA, Inc. | 2015-07-31 |
| REPLY SR,REPLY DR,ESPRIT SR, ESPRIT DR (P950029/S106) | MicroPort CRM USA, Inc. | 2015-07-31 |
| GORE VIABAHN ENDOPROSTHESIS, GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P040037/S083) | W. L. Gore & Associates, Inc. | 2015-07-30 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S114) | Boston Scientific Corp | 2015-07-30 |
| GORE VIABAHN ENDOPROSTHESIS,GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P040037/S082) | W. L. Gore & Associates, Inc. | 2015-07-30 |
| ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (P110028/S016) | Abbott Vascular, Inc. | 2015-07-30 |
| GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE, GORE VIABAHN ENDOPROSTHESIS (P130006/S022) | W. L. Gore & Associates, Inc. | 2015-07-30 |
| GORE VIABAHN ENDR0PROSTHESIS WITH HEPARIN BIOACTIVE SURFAC, GORE VIABAHN ENDOPROTHESIS (P130006/S021) | W. L. Gore & Associates, Inc. | 2015-07-30 |
| FREEDOM DRIVER SYSTEM (P030011/S031) | Syncardia Systems, LLC | 2015-07-29 |
| VASCADE VASCULAR CLOSURE SYSTEM (P120016/S016) | Cardiva Medical, Inc. | 2015-07-29 |
| HV SPLITTER/ADAPTOR KIT, SPRINT QUATTRO LEAD, SPRINT QUATTRO LEAD (P920015/S161) | Medtronic, Inc. | 2015-07-28 |
| 5F MYNXGRIP VASCULAR CLOSURE DEVICE (MX5021) (P040044/S064) | Cordis US Corporation | 2015-07-28 |
| SUPERA PERIPHERAL STENT SYSTEM (P120020/S009) | Abbott Vascular (Idef Technologies Inc) | 2015-07-24 |
| IN PACT ADMIRAL PACLITAXEL-COATED PERCUTANEOUS TRANSLUMICAL ANGIOPLASTLY BALLOON CATHETER (P140010/S007) | Medtronic, Inc. | 2015-07-24 |
| MITRACLIP CLIP DELIVERY SYSTEM; MITRACLIP STEERABLE GUIDE CATHETER (P100009/S012) | ABBOTT MEDICAL | 2015-07-23 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S119) | W. L. Gore & Associates, Inc. | 2015-07-22 |
| SOLO SMART STENTLESS HEART VALVE (P130011/S001) | Corcym Canada Corp | 2015-07-22 |
| TELIGEN,ENERGEN,PUNCTUA,INCEPTA,ORIGEN,INOGEN,DYNAGEN,AUTOGEN ICDS (P960040/S345) | Boston Scientific | 2015-07-21 |
| INVIVE,INTUA,VISIONIST,VALITUDE CRT-PS (P030005/S122) | Guidant Corp. | 2015-07-21 |
| NOVAFLEX DELIVERY SYSTEM (P130009/S016) | Edwards Lifesciences, LLC | 2015-07-21 |
| ADVANTIO,INGENIO,VITALIO,FORMIO,ESSENTIO,ACCOLADE,PROPONENT PACEMAKERS (N970003/S175) | Boston Scientific Corp | 2015-07-21 |
| LATITUDE NXT PATIENT MANAGEMENT SYSTEM (P910077/S149) | Boston Scientific | 2015-07-21 |
| EMBLEM SUBCUTANEOUS ICD (P110042/S045) | Boston Scientific Corporation | 2015-07-21 |
| COGNIS,ENERGEN,PUNCTUA,INCEPTA,ORIGEN,INOGEN,DYNAGEN,AUTOGEN CRT-DS (P010012/S387) | Boston Scientific Corp | 2015-07-21 |
| INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM (P140028) | Boston Scientific Corporation | 2015-07-21 |
| VALITUDE CRT-PS (P030005/S126) | Guidant Corp. | 2015-07-20 |
| ALTURA 2, ESSENTIO, PROPONENT AND ACCOLADE (N970003/S178) | Boston Scientific Corp | 2015-07-20 |
| ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, RELIA IPG (P980035/S429) | Medtronic, Inc. | 2015-07-20 |
| ADVISA DR IPG, ADVISA DR MRI IPG, ADVISA SR MRI IPG (P980035/S430) | Medtronic, Inc. | 2015-07-20 |