| InterStim Therapy System (P970004/S226) | Medtronic Neuromodulation | 2016-09-13 |
| VISUMAX FEMTOSECOND LASER (P150040) | Carl Zeiss Meditec, Inc. | 2016-09-13 |
| Cardiac Resynchronization Therapy- Pacemaker (CRT-P); INVIVE & INTUA MODELS; Ingenio 2 CRT-P Devices VALITUDE MODEL U 12 (P030005/S141) | Guidant Corp. | 2016-09-13 |
| APTIMA HPV ASSAY (P100042/S011) | Gen-Probe Incorporated | 2016-09-13 |
| InterSlim Therapy System (P080025/S121) | Medtronic Neuromodulation | 2016-09-13 |
| Ingenio 2 Pacemakers, ESSENTIO, PROPONENT, ACCOLADE MRI MODELS (P150012/S014) | Boston Scientific | 2016-09-13 |
| EMBLEM S-ICD SYSTEM & EMBLEM MRI S-ICD SYSTEM (P110042/S062) | Boston Scientific Corporation | 2016-09-13 |
| COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030/S054) | Roche Molecular Systems, Inc. | 2016-09-13 |
| Restore, Itrel, and Synergy Spinal Cord Stimulation System and Pisces, Specify, and Vectris Spinal Cord Stimulation Lead (P840001/S341) | Medtronic Neuromodulation | 2016-09-13 |
| AspireAssist (P150024/S003) | Aspire Bariatrics, Inc. | 2016-09-13 |
| SUPARTZ FX, VISCO-3 (P980044/S034) | Seikagaku Corp. | 2016-09-13 |
| APTIMA HPV 16 18/45 GENOTYPE ASSAY (P120007/S009) | Gen-Probe Incorporated | 2016-09-13 |
| NG3 Cardiac Resynchronization Therapy-Defibrillator (CRT); DYNAGEN. INOGEN, ORIGEN CRT-D & X4 CRT-D (P010012/S431) | Boston Scientific Corp | 2016-09-13 |
| Activa Deep Brain Stimulation Therapy System (P960009/S262) | Medtronic, Inc. | 2016-09-13 |
| NG3 Implantable Cardioverter Defibrillator (ICD), ORIGEN, INOGEN, DYNAGEN EL ICD'S; NG2 Implantable Cardioverter Defibri (P960040/S379) | Boston Scientific | 2016-09-13 |
| Revo MRI SureScan IPG (P090013/S231) | Medtronic, Inc. | 2016-09-12 |
| JUVEDERM VOLUMA XC (P110033/S021) | Allergan | 2016-09-12 |
| Adapta/Versa/Sensia, Advisa DR/DR MRI/SR MRI, EnPulse E1/E2, Kappa DR (Kappa 700/600, 900/800)/VDD (Kappa 700) families (P980035/S471) | Medtronic, Inc. | 2016-09-12 |
| Consulta, Syncra, and Viva CRT-Ps (P010015/S305) | Medtronic, Inc. | 2016-09-12 |
| Amplia MRI/MRI Quad, Brava/Brava Quad, Compia MRI/MRI Quad, Concerto/Concert II, Consulta, Maximo II, Protecta/Protecta (P010031/S557) | Medtronic Cardiac Rhythm Disease Management | 2016-09-12 |
| Medtronic Express Monitor (P890003/S361) | Medtronic, Inc. | 2016-09-12 |
| Evera MRI/S DR/S VR/XT DR/XT VR, Intrinsic 30, Marquis VR, Maximo II, Protecta/Protecta VR/XT, Secura/Secura DR, Virtuo (P980016/S596) | Medtronic Cardiac Rhythm Disease Management | 2016-09-12 |
| ENSEMBLE II TRANSCATHETER VALVE DELIVERY SYSTEM (P140017/S004) | Medtronic, Inc. | 2016-09-12 |
| INNOVA (TM) VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM (P140028/S017) | Boston Scientific Corporation | 2016-09-12 |
| HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S081) | Medtronic | 2016-09-12 |
| PROMUS(ELEMENT PLUS/PREMIER) EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S123) | Boston Scientific Corp | 2016-09-09 |
| Restore, Itrel, and Synergy Spinal Cord Stimulation Systems and Pisces, Specify and Vectris Spinal Cord Stimulation Lead (P840001/S340) | Medtronic Neuromodulation | 2016-09-09 |
| ASCENDA INTRATHECAL CATHETER WITH 86 CM SPINAL SEGMENT, 66CM SPINAL SEGMENT, 86 CM SPINAL SEGMENT REVISION KIT, ACCESSOR (P860004/S250) | Medtronic, Inc. | 2016-09-09 |
| ADVIA Centaur® HCV assay (P030056/S009) | Siemens Healthcare Diagnostics | 2016-09-09 |
| SynchroMed Infusion System (P860004/S260) | Medtronic, Inc. | 2016-09-09 |
| ASPIRESR MODEL 106 GENERATOR (P970003/S204) | LivaNova USA, Inc. | 2016-09-09 |
| InterStim Therapy System (P970004/S224) | Medtronic Neuromodulation | 2016-09-09 |
| Activa Deep Brain Stimulation Therapy System (P960009/S261) | Medtronic, Inc. | 2016-09-09 |
| InterStim Therapy System (P080025/S119) | Medtronic Neuromodulation | 2016-09-09 |
| HEPARIN-INDUCED EXTRACORPOREAL LDL PRECIPITATION (H.E.L.P.) FUTURA APHERESIS SYSTEM (P940016/S021) | B. Braun Avitum AG | 2016-09-09 |
| FILSHIE CLIP (MARK VI) SYSTEM (P920046/S009) | Femcare , Ltd. | 2016-09-09 |
| CELLUGEL(R) OPHTHALMIC VISCOSURGICAL DEVICE (P990023/S016) | Alcon Laboratories | 2016-09-09 |
| ELLIPSE FAMILY OF ICDS (P910023/S373) | ABBOTT MEDICAL | 2016-09-08 |
| Therapy Cool Path Ablation Catheters (P060019/S038) | Irvine Biomedical, Inc. | 2016-09-08 |
| OBALON BALLOON SYSTEM (P160001) | Medtimo, Inc. | 2016-09-08 |
| Therapy Dual 8 Ablation Catheters (P040042/S036) | Irvine Biomedical,Inc.(Ibi) | 2016-09-08 |
| LOTRAFILCON A AND B SOFT CONTACT LENSES FOR DAILY AND EXTENDED WEAR (P010019/S052) | Alcon Laboratories, Inc. | 2016-09-08 |
| TactiCath Quartz Catheter and TactiSys Quartz Equipment (P130026/S022) | St Jude Medical | 2016-09-08 |
| T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM (P140015/S014) | Tandem Diabetes Care, Inc. | 2016-09-08 |
| Alere NMP22 BladderChek Test (P940035/S013) | Abbott Diagnostics Scarborough, Inc. | 2016-09-08 |
| SAPIEN 3 TRANSCATHETER HEART VALVE (THV), MODEL 9600TFX (P140031/S021) | Edwards Lifesciences, LLC | 2016-09-08 |
| Livewire TC Steerable Electrophysiology Catheter (P960016/S067) | St Jude Medical | 2016-09-08 |
| Therapy Ablation Catheters (P040014/S031) | Irvine Biomedical, Inc. | 2016-09-08 |
| BIOGLUE SURGICAL ADHESIVE (P010003/S025) | Cryolife, Inc. | 2016-09-08 |
| Therapy Cool Path Duo/Safire Blu Duo Ablation Catheters (P110016/S035) | ABBOTT MEDICAL | 2016-09-08 |
| Platinum VR and DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR ICD's (P980049/S119) | MicroPort CRM USA, Inc. | 2016-09-07 |
| REVO MRI SURESCAN IPG AND PACING SYSTEM RVDR01 (P090013/S221) | Medtronic, Inc. | 2016-09-07 |
| CapSureFix MRI 4076,CapSureFix Novus MRI 5076, CapSureFix MRI SureScan 5086MRI LEAD MODELS (P930039/S149) | Medtronic, Inc. | 2016-09-07 |
| ATTAIN ABILITY MRI SuresScan Lead 4196, ATTAIN ABILITY Plus MRI SureScan Lead Model 4296, ATTAIN ABILITY Straight MRI Su (P080006/S090) | Medtronic, Inc. | 2016-09-07 |
| Platinium VR 1210,1240 (ICD); Platinium DR 1510, 1540 (ICD) (P980049/S121) | MicroPort CRM USA, Inc. | 2016-09-07 |
| Capsure Sense MRI SureScan Lead Model 4074, Capsure Sense MRI SureScan Lead Model 4574 (P830061/S127) | Medtronic Cardiac Rhythm Disease Management | 2016-09-07 |
| HEARTWARE VENTRICULAR ASSIST DEVICE SYSTEM (P100047/S080) | Medtronic | 2016-09-07 |
| THERASCREEN EGFR RGQ PCR KIT (P120022/S013) | QIAGEN GmbH | 2016-09-07 |
| Advisa MRI DR & SR Surescan Implantable Pulse Generators Models A2DR01 & A3SR01 (P980035/S464) | Medtronic, Inc. | 2016-09-07 |
| CERAMAX CERAMIC TOTAL HIP SYSTEM (P070026/S042) | DePuy Orthopaedics, Inc. | 2016-09-07 |
| Amplia MRI SureScan Model DTMB1D4, Amplia MRI Quad SureScan Model DTMB1QQ, Compia MRI SureScan Model DTMC1D4, Compia MR (P010031/S540) | Medtronic Cardiac Rhythm Disease Management | 2016-09-07 |
| Evera MRI XT DR SureScan Model DDMB1D4, Evera MRI XT VR SureScan Model DVMB1D4,Evera MRI S DR SureScan Model DDMC3D4, Ev (P980016/S579) | Medtronic Cardiac Rhythm Disease Management | 2016-09-07 |
| Sprint Quattro Secure S MRI SureScan Lead Model 6935M, Sprint Quattro Secure MRI SureScan Lead Model 6947M (P920015/S177) | Medtronic, Inc. | 2016-09-07 |
| IN PACT(TM) ADMIRAL(TM) PACLITAXEL-COATED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER (P140010/S015) | Medtronic, Inc. | 2016-09-07 |
| Platinium CRT-D 1711, 1741. (P060027/S086) | MicroPort CRM USA, Inc. | 2016-09-07 |
| LCS(R) TOTAL KNEE SYSTEM (P830055/S174) | Depuy, Inc. | 2016-09-07 |
| Platinum CARDIAC RESYNCHRONIZATION THERAPY DEFBRILLATOR CRT's (P060027/S084) | MicroPort CRM USA, Inc. | 2016-09-07 |
| Diva family(includes Diamond II, Ruby II, Topaz II, Jade II, Vita DDDR, Vita DDD and Vita VVIR) Dema family, Selection A (P990001/S122) | Medtronic, Inc. | 2016-09-06 |
| Adapta, Advisa, AT500, EnPulse, EnRhythm, Kappa 600, 650, 700, 800, 900; Relia, Sensia, Sigma, Versa (P980035/S469) | Medtronic, Inc. | 2016-09-06 |
| MYNXGRIP VASCULAR CLOSURE DEVICE (5F, 6F/7F) (P040044/S068) | Cordis US Corporation | 2016-09-06 |
| EnTrust, Gem,Gem II, Gem III, Intrinsic, Marquis, Maximo, Maximo II, Onyx, Protecta DF4, Protecta, Protecta XT DF4 Prote (P980016/S593) | Medtronic Cardiac Rhythm Disease Management | 2016-09-06 |
| Revo MRI, EnRhythm MRI (P090013/S230) | Medtronic, Inc. | 2016-09-06 |
| SAPIEN 3 TRANSCATHETER HEART VALVE (P140031/S019) | Edwards Lifesciences, LLC | 2016-09-06 |
| Kappa 400 (P970012/S099) | Medtronic, Inc. | 2016-09-06 |
| Concerto, Right Ventricular Lead Integrity Alert, Concerto II CRT-D. Consulta CRT-D, InSync II Marquis, II Protect, III (P010031/S554) | Medtronic Cardiac Rhythm Disease Management | 2016-09-06 |
| FORTIFY ASSURA VR, FORTIFY ASSURA DR (P910023/S375) | ABBOTT MEDICAL | 2016-09-06 |
| Elite, Elite II, Minuet, Preva, Preva D, Prodigy, Synergyst II, Thera, Thera-i, Analyzer, Vitatron Legacy, Vitatron Lega (P890003/S358) | Medtronic, Inc. | 2016-09-06 |
| Consulta CRT-P, InSync, InSync III, Syncra CRT-P, Viva CRT-P (P010015/S304) | Medtronic, Inc. | 2016-09-06 |
| ANGIOSCULPT(R) PTCA SCORING BALLOON CATHETER (P050018/S022) | Spectranetics Corp. | 2016-09-06 |
| UNIFY ASSURA, QUADRA ASSURA (P030054/S307) | ABBOTT MEDICAL | 2016-09-06 |
| INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM (P140028/S016) | Boston Scientific Corporation | 2016-09-02 |
| NEUROPACE RNS SYSTEM (P100026/S036) | NeuroPace, Inc. | 2016-09-02 |
| T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM (P140015/S013) | Tandem Diabetes Care, Inc. | 2016-09-01 |
| CERAMIC TRANSCEND HIP ARTICULATION (P030027/S009) | Microport Orthopedics, Inc. | 2016-09-01 |
| ACUITY X4 Drug Collar Component Dwell Time (P010012/S430) | Boston Scientific Corp | 2016-09-01 |
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S143) | Cochlear Americas | 2016-09-01 |
| CapSureFix MRI Lead (P090013/S233) | Medtronic, Inc. | 2016-09-01 |
| AspireAssist (P150024/S001) | Aspire Bariatrics, Inc. | 2016-09-01 |
| OXFORD PARTIAL KNEE SYSTEM (P010014/S055) | Biomet Manufacturing Corp | 2016-09-01 |
| LIFEVEST WEARABLE DEFIBRILLATOR (WCD) 3000, 4000 (P010030/S080) | Zoll Manufacturing Corporation | 2016-09-01 |
| Adapta, Versa, Sensia IPG ADDR01, ADDR03, ADDR06, ADDRL1, ADDRS1, SEDR01, SESR01, VEDR01, ADD01, SEDRL1, SED01, SES01, A (P980035/S473) | Medtronic, Inc. | 2016-09-01 |
| NUCLEUS HYBRID L24 IMPLANT SYSTEM (P130016/S016) | Cochlear Americas | 2016-09-01 |
| SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (S.T.A.R.ANKLE) (P050050/S008) | Djo Global | 2016-09-01 |
| CapSureFix Novus Lead (P930039/S155) | Medtronic, Inc. | 2016-09-01 |
| HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM (P100047/S079) | Medtronic | 2016-09-01 |
| JUVEDERM VOLBELLA XC (P110033/S023) | Allergan | 2016-09-01 |
| NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM (P060037/S046) | Zimmer, Inc. | 2016-09-01 |
| ELCA CORONARY ATHERECTOMY CATHETERS (P910001/S079) | Spectranetics Corp. | 2016-08-31 |
| FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE (P020045/S073) | Medtronic Cryocath, LP | 2016-08-31 |
| Restore, Itrel Spinal Cord Stimulation Systems (P840001/S339) | Medtronic Neuromodulation | 2016-08-31 |