| Activa Deep Brain Stimulation Therapy System (P960009/S260) | Medtronic, Inc. | 2016-08-31 |
| BARD LIFESTENT VASCULAR STENT SYSTEM (P070014/S051) | Bard Peripheral Vascular, Inc. | 2016-08-31 |
| ARCTIC FRONT CARDIAC CRYOABLATION SYSTEM: 23MM AND 28MM ARCTIC FRONT CATHETERS, FREEZOR MAX CATHETER, CRYOCONSOLE, MANUA (P100010/S058) | Medtronic Cryocath, LP | 2016-08-31 |
| INTERSTIM Therapy System for Bowel Control (P080025/S118) | Medtronic Neuromodulation | 2016-08-31 |
| INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL (P970004/S223) | Medtronic Neuromodulation | 2016-08-31 |
| SYNCHROMED INFUSION SYSTEM (P860004/S259) | Medtronic, Inc. | 2016-08-31 |
| PROMETRA PROGRAMMABLE IMPLANTABLE PUMP (P080012/S035) | Infusyn Therapeutics, LLC | 2016-08-31 |
| EPIC VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S037) | Boston Scientific Corp | 2016-08-30 |
| CARDIOMEMS HF SYSTEM (P100045/S010) | ABBOTT MEDICAL | 2016-08-30 |
| REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM (P130030/S028) | Boston Scientific Corp | 2016-08-30 |
| AMS 800 URINARY CONTROL SYSTEM WITH INHIBIZONE TREATMENT (P000053/S065) | Boston Scientific Corp | 2016-08-30 |
| DIMENSION FPSA FLEX REAGENT CARTRIDGE (RF452) (P020027/S024) | Siemens Healthcare Diagnostics | 2016-08-30 |
| MINERVA ENDOMETRIAL ABLATION SYSTEM (P140013/S002) | Axora Medical, Inc. | 2016-08-30 |
| DIMENSION TPSA FLEX REAGENT CARTRIDGE (RF451) (P000021/S029) | Siemens Healthcare Diagnostics | 2016-08-30 |
| EXPRESS SD RENAL PREMOUNTED STENT SYSTEM (P060006/S078) | Boston Scientific Corp | 2016-08-30 |
| SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P150003/S019) | Boston Scientific Corporation | 2016-08-29 |
| REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM (P130030/S027) | Boston Scientific Corp | 2016-08-29 |
| Codman 3000 Series Constant-Flow Implantable Infusion Pump and MedStream Implantable Infusion Pump (P890055/S064) | Intera Oncology | 2016-08-29 |
| PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S132) | Boston Scientific Corp | 2016-08-29 |
| Model 400 Implantable Infusion Pump (P800036/S039) | Intera Oncology | 2016-08-29 |
| ACCESS PSA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (P850048/S042) | Beckman Coulter, Inc. | 2016-08-26 |
| MEDTRONIC COREVALVE(R) EVOLUT R SYSTEM (P130021/S022) | Medtronic, Inc. | 2016-08-26 |
| EXABLATE 2000 SYSTEM (P040003/S018) | Insightec, Ltd. | 2016-08-26 |
| EXABLATE (P110039/S006) | Insightec | 2016-08-26 |
| HYALGAN (P950027/S015) | Fidia Farmaceutici S.P.A. | 2016-08-26 |
| NATRELLE HIGHLY COHESIVE ANATOMICALLY SHAPED SILICONE-FILLED BREAST IMPLANTS (P040046/S014) | Allergan | 2016-08-25 |
| NIRxcell CoCr Cornary Stent on RX System (P110004/S020) | Medinol, Ltd. | 2016-08-25 |
| MiniMed 530G Insulin Pump (P120010/S093) | Medtronic, Inc. | 2016-08-25 |
| CARTIVA SYNTHETIC CARTILAGE IMPLANT (P150017/S001) | Cartiva, Inc. | 2016-08-25 |
| PARADIGM REAL-TIME REVEL INSULIN SYSTEM (P150019/S018) | Medtronic Minimed | 2016-08-25 |
| ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM (P150023/S002) | Abbott Vascular, Inc. | 2016-08-25 |
| Paradigm Real-Time Revel Insulin Pump & Paradigm Real-Time Insulin Pump. (P980022/S193) | Medtronic Minimed | 2016-08-25 |
| QUANTIFERON-TB GOLD AND TB GOLD- Test (reference lab pack) (P010033/S030) | Qiagen | 2016-08-25 |
| G4 PLATINUM CONTIUOUS GLUCOSE MONITORING SYSTEM (P120005/S052) | Dexcom, Inc. | 2016-08-25 |
| NATRELLE SILICONE-FILLED BREAST IMPLANTS. (P020056/S032) | Allergan | 2016-08-25 |
| ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S259) | Medtronic, Inc. | 2016-08-25 |
| RESTORE, ITREL, AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES, SPECIFY, AND VECTRIS SPINAL CORD STIMULATIONS LE (P840001/S338) | Medtronic Neuromodulation | 2016-08-25 |
| MEDTRONIC(R) TRANSVENE LEAD SYSTEM (P920015/S175) | Medtronic, Inc. | 2016-08-24 |
| MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL (P970004/S218) | Medtronic Neuromodulation | 2016-08-24 |
| CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION (P010031/S538) | Medtronic Cardiac Rhythm Disease Management | 2016-08-24 |
| ANIMAS VIBE SYSTEM (P130007/S018) | Animas Corp. | 2016-08-24 |
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S149) | Cochlear Americas | 2016-08-24 |
| NUCLEUS 24 HYBRID SYSTEM (P130016/S020) | Cochlear Americas | 2016-08-24 |
| MEDTRONIC INTERSTIM THERAPY SYSTEM FOR BOWEL (P080025/S113) | Medtronic Neuromodulation | 2016-08-24 |
| MEDTRONIC ATTAIN ABILITY MODEL 4196 LEAD (P080006/S089) | Medtronic, Inc. | 2016-08-24 |
| PROPEL (P100044/S020) | Intersect Ent. | 2016-08-24 |
| WALLSTENT ENDOPROSTHESIS (VENOUS) (P980033/S045) | Boston Scientific Corporation | 2016-08-24 |
| OVATION ABDOMINAL STENT GRAFT SYSTEM PLATFORM (P120006/S026) | Endologix, LLC | 2016-08-24 |
| MEDTRONIC(R) CAPSUREFIX LEAD MODEL 4068,4067,4568 (P930039/S148) | Medtronic, Inc. | 2016-08-24 |
| REVO MRI SURESCAN IPG AND PACING SYSTEM (P090013/S220) | Medtronic, Inc. | 2016-08-24 |
| WALLSTENT ILIAC ENDOPROSTHESIS (P940019/S047) | Boston Scientific Scimed, Inc. | 2016-08-24 |
| WALLSTENT ENDOPROSTHESIS (TIPS) (P930031/S056) | Boston Scientific Corp | 2016-08-24 |
| FLUENCY PLUS ENDOVASCULAR STENT GRAFT (P130029/S004) | Bard Peripheral Vascular, Inc. | 2016-08-24 |
| NIRxcell CoCr Coronary Stent on RX System (P110004/S019) | Medinol, Ltd. | 2016-08-23 |
| COFLEX® INTERLAMINAR TECHNOLOGY (P110008/S005) | Companion Spine France | 2016-08-23 |
| CARDIOGENESIS TMR LASER SYSTEM (P970029/S032) | Cryolife, Inc. | 2016-08-23 |
| AUTODELFIA HAFP TEST SYSTEM (P970037/S009) | Revvity, Inc. | 2016-08-23 |
| NUCLEUS HYBRID L24 IMPLANT SYSTEM (P130016/S017) | Cochlear Americas | 2016-08-23 |
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S144) | Cochlear Americas | 2016-08-23 |
| EDWARDS CRIMPER (P140031/S020) | Edwards Lifesciences, LLC | 2016-08-23 |
| GORE CARDIOFORM Septal Occluder (P050006/S051) | W. L. Gore & Associates, Inc. | 2016-08-23 |
| ACUITY X4 STRAIGHT, ACUITY X4 SPIRAL S, ACUITY X4 SPIRAL L Quadripolar Coronary Venous Pace/Sense Leads (P010012/S423) | Boston Scientific Corp | 2016-08-23 |
| Protego SD 60/16, Protego SD 65/16, Protego SD 65/18, Protego SD 75/18, Protego TD 65/16, Protego TD 65/18, Protego TD 7 (P980023/S077) | Biotronik, Inc. | 2016-08-22 |
| RESTORE, ITREL, AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES, SPECIFY, AND VECTRIS SPINAL CORD STIMULATION LEA (P840001/S337) | Medtronic Neuromodulation | 2016-08-22 |
| ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S258) | Medtronic, Inc. | 2016-08-22 |
| INTERSTIM THERAPY SYSTEM (URINARY) (P970004/S222) | Medtronic Neuromodulation | 2016-08-22 |
| CAPSUREFIX NOVUS LEAD (P930039/S154) | Medtronic, Inc. | 2016-08-22 |
| INTERSTIM THERAPY SYSTEM (BOWEL) (P080025/S117) | Medtronic Neuromodulation | 2016-08-22 |
| SYNCHROMED INFUSION SYSTEM (P860004/S258) | Medtronic, Inc. | 2016-08-22 |
| ENDOTAK RELIANCE G/SG DEFIBRILLATION LEADS AND G/SG WITH 4-SITE CONNECTOR DEFIBRILLATION LEADS (P910073/S139) | Boston Scientific | 2016-08-22 |
| COREVALVE (TM) EVOLUTE (TM) R SYSTEM (P130021/S024) | Medtronic, Inc. | 2016-08-22 |
| INTEGRA ARTIFICIAL SKIN & MESHED DERMAL REGENERATION TEMPLATE,INTEGRA OMNIGRAFT DERMAL REGENERATION MATRIX, Integra Me (P900033/S055) | Integra Lifesciences Corp. | 2016-08-22 |
| VENASEAL CLOSURE SYSTEM (P140018/S003) | Medtronic Vascular, Inc. | 2016-08-21 |
| ADVIA CENTAUR ANTI HBS2 ASSAY (P100039/S004) | Siemens Healthcare Diagnostics, Inc. | 2016-08-20 |
| Dynagen EL & Mini, Inogen EL & Mini, Origen EL & MIni IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM (P960040/S376) | Boston Scientific | 2016-08-19 |
| Dynagen & X4, Inogen & X4, Origen & X4 CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (P010012/S427) | Boston Scientific Corp | 2016-08-19 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (P130009/S062) | Edwards Lifesciences, LLC | 2016-08-19 |
| PROMUS(ELEMENT PLUS/PREMIER) EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S131) | Boston Scientific Corp | 2016-08-19 |
| C-FLEX MODEL 570C, C-Flex Aspheric 970C and 600 C Aspheric INTRAOCULAR LENS (IOL) (P060011/S010) | Rayner Intraocular Lenses , Ltd. | 2016-08-19 |
| COLOGUARD (P130017/S010) | Exact Sciences Corporation | 2016-08-19 |
| Allure, Allure RF, Allure Quadra, Allure Quadra RF - PM3120, PM3222, PM3140, PM3242 (P030035/S148) | ABBOTT MEDICAL | 2016-08-19 |
| CHILLI II (P980003/S069) | Boston Scientific Corp | 2016-08-19 |
| QUANTIFERON-TB GOLD AND TB GOLD Test (reference lab pack) (P010033/S029) | Qiagen | 2016-08-19 |
| Assurity - PM1240, PM2240, Assurity+ - PM1260, PM2260, Endurity - PM1160, PM2160, Endurity Core - PM1152, PM2152 (P880086/S274) | ABBOTT MEDICAL | 2016-08-19 |
| SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES (P140031/S015) | Edwards Lifesciences, LLC | 2016-08-19 |
| ALGOVITA SPINAL CORD STIMULATION SYSTEM (P130028/S012) | Nuvectra Corporation | 2016-08-19 |
| BLAZER OI; INTELLANAV OI (P150005/S010) | Boston Scientific Corp | 2016-08-19 |
| Emblem SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM (P110042/S060) | Boston Scientific Corporation | 2016-08-19 |
| SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P150003/S018) | Boston Scientific Corporation | 2016-08-19 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES (P130009/S057) | Edwards Lifesciences, LLC | 2016-08-18 |
| MELAFIND (P090012/S011) | Strata Skin Sciences, Inc. | 2016-08-18 |
| SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES (P140031/S010) | Edwards Lifesciences, LLC | 2016-08-18 |
| AXIUM SHEATHS (P150004/S004) | ABBOTT MEDICAL | 2016-08-18 |
| COBAS® AMPLIPREP/COBAS® TAQMAN® CMV TEST (CAP/CTM CMV TEST) (P110037/S028) | Roche Molecular Systems, Inc. | 2016-08-18 |
| COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030/S053) | Roche Molecular Systems, Inc. | 2016-08-18 |
| ANGIOJET ULTRA XMI, SPIROFLEX, SPIROFLEX VG, DISTAFLEX THROMBECTOMY SET'S (P980037/S058) | Boston Scientific Corp | 2016-08-18 |
| COBAS AmpliPrep/Cobas TAQMAN HBV TEST and Cobas TaqMan HBV Test for user with The High Pure System (P050028/S053) | Roche Molecular Systems, Inc. | 2016-08-18 |
| SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P150003/S017) | Boston Scientific Corporation | 2016-08-18 |
| LIFE PULSE HIGH FREQUENCY VENTILATOR (P850064/S033) | Bunnell, Inc. | 2016-08-18 |
| WOLVERINE CORONARY CUTTING BALLOON (MONORAIL & OVER-THE-WIRE) (P950020/S072) | Boston Scientific Corp | 2016-08-18 |