| LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (P000008/S037) | Medtimo, Inc. | 2016-03-28 |
| DYNAGEN ICD Models D150, D151, D152, D153; INOGEN ICD Models D140, (P960040/S361) | Boston Scientific | 2016-03-28 |
| CHEATHAM PLATINUM (CP) STENT SYSTEM (Covered CP Stent, Covered Mounted CP Stent, CP Stent, Mounted CP Stent) (P150028) | NuMED, Inc. | 2016-03-25 |
| MEDTRONIC COREVALVE SYSTEM (P130021/S020) | Medtronic, Inc. | 2016-03-25 |
| MELODY TRANSCATHETER PULMONARY VALVE (TPV), ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM (DS) (P140017/S002) | Medtronic, Inc. | 2016-03-25 |
| SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES (P140031/S012) | Edwards Lifesciences, LLC | 2016-03-25 |
| VNS THERAPY SYSTEM (P970003/S193) | LivaNova USA, Inc. | 2016-03-24 |
| ARCHITECT ANTI-HCV ASSAY; ARCHITECT ANTI-HCV CALIBRATOR; ARCHITECT ANTI-HCV CONTROL (P050042/S033) | Abbott Laboratories, Inc. | 2016-03-24 |
| CRYSTALENS AND TRULIGN TORIC INTRAOCULAR LENSES (IOLS) (P030002/S035) | Bausch & Lomb, Inc. | 2016-03-24 |
| VASCADE VASCULAR CLOSURE SYSTEM (P120016/S017) | Cardiva Medical, Inc. | 2016-03-24 |
| T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM (P140015/S006) | Tandem Diabetes Care, Inc. | 2016-03-24 |
| GORE HELEX SEPTAL OCCLUDER (P050006/S050) | W. L. Gore & Associates, Inc. | 2016-03-24 |
| TAP SYSTEM 2A (P840002/S013) | Cardiocommand, Inc. | 2016-03-24 |
| PRECISION SPINAL CORD STIMULATION(SCS) SYSTEM (P030017/S248) | Boston Scientific Corp | 2016-03-24 |
| VNS THERAPY SYSTEM (P970003/S194) | LivaNova USA, Inc. | 2016-03-24 |
| COBAS HCV TEST (P150015/S001) | Roche Molecular Systems, Inc. | 2016-03-24 |
| TACTICATH QUARTZ SET (P130026/S017) | St Jude Medical | 2016-03-24 |
| THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (P060040/S053) | ABBOTT MEDICAL | 2016-03-24 |
| COBAS HBV TEST (P150014/S001) | Roche Molecular Systems, Inc. | 2016-03-24 |
| ORIGEN EL ICD D050, D051, D052, D053; ORIGEN MINI ICD D000, D001, D002, D003; DYNAGEN EL ICD D150, D151, D152, D15 (P960040/S366) | Boston Scientific | 2016-03-23 |
| MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWARE (P980035/S458) | Medtronic, Inc. | 2016-03-23 |
| VNS THERAPY SYSTEM (P970003/S192) | LivaNova USA, Inc. | 2016-03-23 |
| ARISTA AH ABSORBABLE HEMOSTAT (P050038/S029) | Davol, Inc. | 2016-03-23 |
| VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS (P980016/S577) | Medtronic Cardiac Rhythm Disease Management | 2016-03-23 |
| MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEM (P010015/S295) | Medtronic, Inc. | 2016-03-23 |
| REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM MONORAIL AND OVER THE WIRE (P130030/S022) | Boston Scientific Corp | 2016-03-23 |
| REVO MRI SURESCAN IPG AND PACING SYSTEM (P090013/S219) | Medtronic, Inc. | 2016-03-23 |
| FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES (P010019/S048) | Alcon Laboratories, Inc. | 2016-03-23 |
| Evera S DR ICD DDBC3D1, DDBC3D4; Evera S VR ICD DVBC3D1, DVBC3D4 (P980016/S575) | Medtronic Cardiac Rhythm Disease Management | 2016-03-23 |
| DYNAGEN CRT-D G150, G151, G154; DYNAGEN X4 CRT-D G156, G158; INOGEN CRT-D G140, G141; INOGEN X4 CRT-D G146, G148 (P010012/S412) | Boston Scientific Corp | 2016-03-23 |
| PROPEL MINI SINUS IMPLANT (P100044/S018) | Intersect Ent. | 2016-03-23 |
| CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION (P010031/S537) | Medtronic Cardiac Rhythm Disease Management | 2016-03-23 |
| FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES (P010019/S047) | Alcon Laboratories, Inc. | 2016-03-23 |
| PROMUS(ELEMENT PLUS/PREMIER) EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S121) | Boston Scientific Corp | 2016-03-23 |
| FOCUS NIGHT & DAY (LOTRAFILCON A) SOFT CONTACT LENSES (P000030/S002) | Alcon Laboratories, Inc. | 2016-03-23 |
| MINIMED 530G SYSTEM (P120010/S083) | Medtronic, Inc. | 2016-03-23 |
| CERAMAX Ceramic Total Hip System (P070026/S034) | DePuy Orthopaedics, Inc. | 2016-03-23 |
| PARADIGM REAL-TIME REVEL SYSTEM (P150019/S008) | Medtronic Minimed | 2016-03-23 |
| Brava CRT-D DTBC1D4, DTBC1D1; Brava Quad CRT-D DTBC1Q1, DTBC1QQ; Protecta CRT-D D334 TRM, Protecta CRT-D D334TRG; Protec (P010031/S536) | Medtronic Cardiac Rhythm Disease Management | 2016-03-23 |
| EXTERNAL PULSE GENERATOR, 2 PORT HEADER, ADHESIVE POUCH, EPG; NON-ADHESIVE POUCH WITH BELT. (P010032/S110) | ABBOTT MEDICAL | 2016-03-22 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES (P130009/S051) | Edwards Lifesciences, LLC | 2016-03-22 |
| SOUNDTECH DIRECT AND MAXUM (P010023/S013) | Ototronix, LLC | 2016-03-22 |
| SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T) (P030011/S041) | Syncardia Systems, LLC | 2016-03-22 |
| FALOPE-RING BAND CONTRACEPTIVE TUBAL OCCLUSION SYSTEM (P870076/S018) | Gyrus Acmi, Inc. | 2016-03-22 |
| EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESES (P860057/S145) | Edwards Lifesciences, LLC | 2016-03-22 |
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S145) | Cochlear Americas | 2016-03-22 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P110021/S056) | Edwards Lifesciences, LLC | 2016-03-22 |
| HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S073) | Medtronic | 2016-03-22 |
| GEL-ONE (P080020/S019) | Seikagaku Corp. | 2016-03-22 |
| SUPARTZ FX (P980044/S031) | Seikagaku Corp. | 2016-03-22 |
| SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T) (P030011/S040) | Syncardia Systems, LLC | 2016-03-22 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P100041/S069) | Edwards Lifesciences, LLC | 2016-03-22 |
| SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES (P140031/S011) | Edwards Lifesciences, LLC | 2016-03-22 |
| NUCLEUS HYBRID L24 IMPLANT SYSTEM (P130016/S018) | Cochlear Americas | 2016-03-22 |
| INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM (P140028/S008) | Boston Scientific Corporation | 2016-03-21 |
| MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEM (P010015/S293) | Medtronic, Inc. | 2016-03-21 |
| MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWARE (P980035/S456) | Medtronic, Inc. | 2016-03-21 |
| BIOFINITY (COMFILCON A) (P080011/S041) | CooperVision, Inc. | 2016-03-21 |
| I-FACTOR PEPTIDE ENHANCED BONE GRAFT (P140019/S002) | Cerapedics, LLC | 2016-03-18 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES (P130009/S050) | Edwards Lifesciences, LLC | 2016-03-18 |
| EBI SPF IMPLANTABLE SPINAL FUSION STIMULATOR (P850035/S042) | Ahp Eos Buyer, Inc. | 2016-03-18 |
| PRECISION SPINAL CORD STIMULATION(SCS) SYSTEM (P030017/S247) | Boston Scientific Corp | 2016-03-18 |
| CAPSUREFIX MRI SURE AND SCAN LEAD (P090013/S164) | Medtronic, Inc. | 2016-03-18 |
| WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE (LAAC) DEVICE (P130013/S004) | Boston Scientific Corp | 2016-03-18 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P110021/S055) | Edwards Lifesciences, LLC | 2016-03-18 |
| NOVOCURE LTD'S NOVOTTF-100A TREATMENT KIT (P100034/S016) | Novocure, GmbH | 2016-03-18 |
| SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES (P140031/S009) | Edwards Lifesciences, LLC | 2016-03-18 |
| PROMUS(ELEMENT PLUS/PREMIER) EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S120) | Boston Scientific Corp | 2016-03-18 |
| AMPLATZER MUSCULAR VSD OCCLUDER (P040040/S026) | ABBOTT MEDICAL | 2016-03-18 |
| ESTEEM (P090018/S030) | Envoy Medical Corporation | 2016-03-18 |
| BOSTON SCIENTIFIC EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S072) | Boston Scientific Corp | 2016-03-18 |
| SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P150003/S007) | Boston Scientific Corporation | 2016-03-18 |
| EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESES (P860057/S144) | Edwards Lifesciences, LLC | 2016-03-18 |
| REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM MONORAIL AND OVER THE WIRE (P130030/S021) | Boston Scientific Corp | 2016-03-18 |
| EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM (P090003/S039) | Boston Scientific Corporation | 2016-03-18 |
| VNS THERAPY SYSTEM (P970003/S191) | LivaNova USA, Inc. | 2016-03-18 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P100041/S068) | Edwards Lifesciences, LLC | 2016-03-18 |
| CAPSUREFIX NOVUS, LEAD AND CAPSUREFIX , NOVUS MRI SURESCAN AND VITATRON CRYSTALLINE LEADS (P930039/S123) | Medtronic, Inc. | 2016-03-18 |
| ALGOVITA SPINAL CORD STIMULATION SYSTEM (P130028/S003) | Nuvectra Corporation | 2016-03-18 |
| SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T) (P030011/S042) | Syncardia Systems, LLC | 2016-03-17 |
| H.E.L.P. PLASMAT FUTURA SYSTEM (P940016/S020) | B. Braun Avitum AG | 2016-03-17 |
| XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S081) | Abbott Vascular | 2016-03-17 |
| PARADIGM REAL-TIME REVEL SYSTEM (P150019/S005) | Medtronic Minimed | 2016-03-17 |
| EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESES (P860057/S143) | Edwards Lifesciences, LLC | 2016-03-17 |
| COLLACOTE(TM) (P840062/S055) | Integra Lifesciences Corp. | 2016-03-17 |
| HELISTAT(TM) ABSORBABLE COLLAGEN HEMOSTATIC SPONGE (P850010/S069) | Integra LifeSciences Corporation | 2016-03-17 |
| PARADIGM REAL-TIME REVEL SYSTEM (P150019/S006) | Medtronic Minimed | 2016-03-17 |
| CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS (P050019/S024) | Boston Scientific Corp | 2016-03-17 |
| EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM (P090003/S040) | Boston Scientific Corporation | 2016-03-17 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES (P130009/S049) | Edwards Lifesciences, LLC | 2016-03-17 |
| HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S072) | Medtronic | 2016-03-17 |
| I-FACTOR PEPTIDE ENHANCED BONE GRAFT (P140019/S001) | Cerapedics, LLC | 2016-03-17 |
| COLLASTAT (P810006/S070) | Integra LifeSciences Corporation | 2016-03-17 |
| ELECSYS ANTI-HCV IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E411 IMMUNOSSAY ANALYZER (P090007/S015) | Roche Diagnostics Corp. | 2016-03-16 |
| ELECSYS® HBEAG IMMUNOASSAY AND ELECSYS® PRECICONTROL HBEAG (P130015/S006) | Roche Diagnostics Operations, Inc. | 2016-03-16 |
| ELECSYS HBSAG IMMUNOASSAY, ELECSYS HBSAG CONFIRMATORY, AND PRECICONTROL HBSAG (P990012/S026) | Roche Diagnostics Corp. | 2016-03-16 |
| ELECSYS TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSET (P990056/S023) | Roche Diagnostics Corp. | 2016-03-16 |
| ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHECK (P000027/S022) | Roche Diagnostics Corp. | 2016-03-16 |
| ELECSYS ANTI-HBS (P010054/S028) | Roche Diagnostics Corp. | 2016-03-16 |
| ELECSYS ANTI-HBC IGM IMMUNOASSAY & ELECSYS PREICONTROL ANTI-HBC IGM FOR USE ON THE MODULAR ANAYTICS E170 IMMUNOASSAY ANA (P110025/S015) | Roche Diagnostics Corp. | 2016-03-16 |