| ZILVER VASCULAR STENT (P050017/S014) | Cook Ireland, Ltd. | 2016-12-16 |
| LUTONIX DRUG COATED BALLOON (P130024/S017) | Lutonix | 2016-12-16 |
| VISIONIST, VISIONIST X4, VALITUDE, VALITUDE X4, INVIVE, INTUA (P030005/S138) | Guidant Corp. | 2016-12-16 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S090) | W. L. Gore & Associates, Inc. | 2016-12-16 |
| Inspire II Implantable Pulse Generator (P130008/S017) | Inspire Medical Systems | 2016-12-16 |
| Juvederm Ultra, Ultra XC, Ultra Plus, Ultra Plus XC, 30; Juvedern Ultra XC (P050047/S054) | Allergan | 2016-12-16 |
| ZILVER PTX DRUG-ELUTING PERIPHERAL STENT (P100022/S021) | Cook Ireland, Ltd. | 2016-12-16 |
| Activa Deep Brain Stimulation Therapy System (P960009/S266) | Medtronic, Inc. | 2016-12-15 |
| SINGLE PIECE POSTERIOR CHAMBER (P840060/S044) | Alcon Laboratories | 2016-12-15 |
| GORE CARDIOFORM SEPTAL OCCLUDER SHARED HLC IN-LINE DIPPER (P050006/S055) | W. L. Gore & Associates, Inc. | 2016-12-15 |
| VISTAKON (SENOFILCON A) CONTACT LENS, (P040045/S062) | Vistakon, Division of Johnson & Johnson Vision Car | 2016-12-15 |
| Restore, Itrel, and Synergy Spinal Cord Stimulation Systems and Pisces, Resume, Extensions, Specify, and Vectris Spinal (P840001/S347) | Medtronic Neuromodulation | 2016-12-15 |
| SINGLE PIECE ANTERIOR CHAMBER IOL (P880087/S026) | Alcon Laboratories | 2016-12-15 |
| GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P040037/S096) | W. L. Gore & Associates, Inc. | 2016-12-15 |
| GORE VIABAHN ENDOPROSTHESIS AND ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P130006/S035) | W. L. Gore & Associates, Inc. | 2016-12-15 |
| MECHANICAL HEART VALVES (P810002/S099) | ABBOTT MEDICAL | 2016-12-15 |
| INTERSTIM THERAPY SYSTEM (BOWEL) (P080025/S127) | Medtronic Neuromodulation | 2016-12-15 |
| ACRYSOF (R) POSTERIOR CHAMBER INTRAOCULAR LENS (IOL) (P930014/S098) | Alcon Laboratories, Inc. | 2016-12-15 |
| MULTI-PIECE POSTERIOR CHAMBER (P810032/S067) | Alcon Laboratories | 2016-12-15 |
| PRESTIGE LP CERVICAL DISC (P090029/S006) | Medtronic Sofamor Danek USA, Inc. | 2016-12-15 |
| AspireAssist (P150024/S005) | Aspire Bariatrics, Inc. | 2016-12-15 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S089) | W. L. Gore & Associates, Inc. | 2016-12-15 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S139) | W. L. Gore & Associates, Inc. | 2016-12-15 |
| InterStim Therapy System (URINARY) (P970004/S232) | Medtronic Neuromodulation | 2016-12-15 |
| OBALON BALLOON SYSTEM (P160001/S002) | Medtimo, Inc. | 2016-12-15 |
| HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S087) | Medtronic | 2016-12-15 |
| OraQuick HCV Rapid Antibody Test (P080027/S025) | OraSure Technologies, Inc. | 2016-12-15 |
| ACRYSOF RESTOR POSTERIOR CHAMBER IOL (P040020/S065) | Alcon Research, Ltd. | 2016-12-15 |
| CapSure Epicardial Pacing Lead (P950024/S070) | Medtronic, Inc. | 2016-12-14 |
| GORE TIGRIS VASCULAR STENT (P160004/S002) | W. L. Gore & Associates, Inc. | 2016-12-14 |
| ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL (P020014/S048) | Bayer Pharma AG | 2016-12-14 |
| REVO MRI SURESCAN IPG AND CAPSUREFIX MRI LEAD (P090013/S241) | Medtronic, Inc. | 2016-12-14 |
| ELECSYS ANTI-HBC IGM IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC IGM (P110022/S018) | Roche Diagnostics Corp. | 2016-12-14 |
| NEUROPACE RNS SYSTEM (P100026/S046) | NeuroPace, Inc. | 2016-12-14 |
| ELECSYS ANTI-HBC IGM IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC IGM (P110031/S015) | Roche Diagnostics Corp. | 2016-12-14 |
| CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION (P010031/S571) | Medtronic Cardiac Rhythm Disease Management | 2016-12-14 |
| ATTAIN BIPOLAR OTW LEAD, ATTAIN OTW LV LEAD, CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P (P010015/S313) | Medtronic, Inc. | 2016-12-14 |
| AMS 800 Urinary Control System with and without InhibiZone Treatment (P000053/S069) | Boston Scientific Corp | 2016-12-14 |
| VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS (P980016/S611) | Medtronic Cardiac Rhythm Disease Management | 2016-12-14 |
| ATTAIN STARFIX MODEL 4195 LEAD (P060039/S075) | Medtronic, Inc. | 2016-12-14 |
| Adapta, Versa, Sensia IPG Models ADDR01, ADDR03, ADDR06, ADDRL1, ADDRS1, SEDR01, SESR01, VEDR01, ADD01, SEDRL1, SED01, S (P980035/S484) | Medtronic, Inc. | 2016-12-14 |
| MEDTRONIC ATTAIN ABILITY/PERFORMA LEAD (P080006/S103) | Medtronic, Inc. | 2016-12-14 |
| MEDTRONIC(R) CAPSUREFIX LEAD (P930039/S163) | Medtronic, Inc. | 2016-12-14 |
| MEDTRONIC SELECTSECURE LEAD/ANCHORING SLEEVE KIT (P030036/S089) | Medtronic Cardiac Rhythm Disease Management | 2016-12-14 |
| THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) (P060040/S062) | ABBOTT MEDICAL | 2016-12-14 |
| ADHESIVE, CAPSURE SENSE LEAD, CAPSURE SP LEAD, CAPSURE SP NOVUS LEAD, VITATRON CRYSTALLINE AND EXCELLENCE PS+ LEAD (P830061/S138) | Medtronic Cardiac Rhythm Disease Management | 2016-12-14 |
| MEDTRONIC PCD TACHYARRHYTHMIA CONTROL SYSTEM (P900061/S144) | Medtronic Cardiac Rhythm Disease Management | 2016-12-14 |
| IN PACT ADMIRAL PACLITAXEL-ELUTING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER (P140010/S027) | Medtronic, Inc. | 2016-12-14 |
| MEDTRONIC.KAPPA 400 SERIES PACEMAKERS (P970012/S100) | Medtronic, Inc. | 2016-12-14 |
| DISPOSABLE EPG COVER/DISPOSABLE POUCH (P820003/S137) | Medtronic Cardiac Rhythm Disease Management | 2016-12-14 |
| ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM (P980037/S062) | Boston Scientific Corp | 2016-12-14 |
| AMS 700 Inflatable Penile Prosthesis (IPP)with and without InhibiZone Treatment and AMS Ambicor Inflatable Penile Prosth (N970012/S119) | Boston Scientific Corp | 2016-12-14 |
| ATRICURE SYNERGY ABLATION SYSTEM (P100046/S007) | AtriCure, Inc. | 2016-12-14 |
| CAPSURE SP NOVUS, CAPSURE SP Z, CAPSURE Z NOVUS, VITATRON IMPULSE II LEAD (P850089/S121) | Medtronic Cardiac Rhythm Disease Management | 2016-12-14 |
| Analyzer Software,Battery Check Monitor,CapSure VDD 2 Lead,CareLink Programmer,CareLink Programmer RF (P890003/S367) | Medtronic, Inc. | 2016-12-14 |
| TRUFILL N-BUTYL CYANOACRYLATE LIQUID EMBOLIC SYSTEM (P990040/S023) | Cerenovus, Inc. | 2016-12-14 |
| MYOCARDIAL PACING LEAD (P120017/S007) | Medtronic, Inc. | 2016-12-14 |
| Catheter RF Contactr, Catheter RF Enhancr II (P930029/S057) | Medtronic, Inc. | 2016-12-14 |
| SAPIEN 3 TRANSCATHETER HEART VALVE (P140031/S027) | Edwards Lifesciences, LLC | 2016-12-14 |
| ADAPTA, VERSA, SENSIA IPG (P980035/S482) | Medtronic, Inc. | 2016-12-14 |
| MICRA TPS (P150033/S011) | Medtronic, Inc. | 2016-12-14 |
| EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (P110023/S023) | Medtronic Vascular, Inc. | 2016-12-14 |
| CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS (P050019/S026) | Boston Scientific Corp | 2016-12-14 |
| Transvene CS/SVC Lead (P980050/S108) | Medtronic, Inc. | 2016-12-14 |
| WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE (LAAC) DEVICE (P130013/S011) | Boston Scientific Corp | 2016-12-14 |
| ELECSYS ANTI-HBC IGM IMMUNOASSAY & ELECSYS PREICONTROL ANTI-HBC IGM (P110025/S016) | Roche Diagnostics Corp. | 2016-12-14 |
| MEDTRONIC(R) TRANSVENE LEAD SYSTEM (P920015/S189) | Medtronic, Inc. | 2016-12-14 |
| SCS ACCESSORIES, SCS EXTENSIONS, SCS LEADS, SCS LEADS 1x8 FAMILY, SCS LEADS PISCES FAMILY, SCS LEADS RESUME FAMILY, SCS (P840001/S346) | Medtronic Neuromodulation | 2016-12-13 |
| DBS Accessories DBS Extensions DBS Leads DBS Neurostimulators 37022 DBS Neurostimulators 37601,37602,37603,DBS Programmi (P960009/S265) | Medtronic, Inc. | 2016-12-13 |
| Qualcrimp crimping accessory (Packaged with the Commander Delivery System) (P140031/S026) | Edwards Lifesciences, LLC | 2016-12-13 |
| SNS Urinary Accessories SNS Urinary Extensions SNS Urinary Leads SNS Urinary Neurostimulator 3023,3058 SNS Urinary Progr (P970004/S231) | Medtronic Neuromodulation | 2016-12-13 |
| COLOGUARD (P130017/S014) | Exact Sciences Corporation | 2016-12-13 |
| EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESES (P860057/S142) | Edwards Lifesciences, LLC | 2016-12-13 |
| SNS Bowel Accessories SNS Bowel Extensions SNS Bowel LeadsSNS Bowel Neurostimulators SNS Bowel Programming SNS Bowel Scr (P080025/S126) | Medtronic Neuromodulation | 2016-12-13 |
| ABBOTT REALTIME HBV ASSAY/ CALIBRATOR KIT/CONTROL KIT & ABBOTT MSAMPLE PREPARATION SYSTEM DNA (P080026/S019) | Abbott Molecular, Inc. | 2016-12-13 |
| ATTUNE TOTAL KNEE SYSTEM (P830055/S176) | Depuy, Inc. | 2016-12-13 |
| INTELLANAV MIFI XP; INTELLATIP MIFI XP (P020025/S091) | Boston Scientific | 2016-12-13 |
| Drug Delivery Kits for Refills (P990034/S035) | Medtronic, Inc. | 2016-12-13 |
| DRUG dELIVERY ACCESSORIES, DRUG DELIVERY CATHETERS, DRUG DELIVERY INFUSION PUMPS SYNCHROMED FAMILY, DRUG DELIVERY KITS F (P860004/S263) | Medtronic, Inc. | 2016-12-13 |
| HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S088) | Medtronic | 2016-12-13 |
| Qualcrimp crimping accessory (Packaged with the NovaFlex+ Delivery System) (P130009/S067) | Edwards Lifesciences, LLC | 2016-12-13 |
| HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM (P100047/S077) | Medtronic | 2016-12-13 |
| WOLVERINE CORONARY CUTTING BALLOON (P950020/S078) | Boston Scientific Corp | 2016-12-12 |
| HEALON DUET DUAL PACK (P810031/S061) | Johnson & Johnson Surgical Vision, Inc. | 2016-12-12 |
| AUTOGEN X4 CRT-D MODEL G166, G168 and AUTOGEN CRT-D MODELS G160, G161, G164 (P010012/S424) | Boston Scientific Corp | 2016-12-12 |
| REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM. (P130030/S033) | Boston Scientific Corp | 2016-12-12 |
| ESSENTIO MRI Models L110, L111, L131; (P150012/S020) | Boston Scientific | 2016-12-12 |
| HEALON ENDOCOAT OPHTHALMIC VISCOSURGICAL DEVICES (OVD) (3% SODIUM HYALURONATE) (P110007/S011) | Johnson & Johnson Surgical Vision, Inc. | 2016-12-12 |
| MEDTRONIC COREVALVE(R) SYSTEM (P130021/S026) | Medtronic, Inc. | 2016-12-12 |
| LATITUDE NXT System (P910077/S154) | Boston Scientific | 2016-12-12 |
| ESSENTIO Models L100, L101, L121; PROPONENT Models L200, L201, L221; ACCOLADE Models L300, L301, L321; PROPONENT MRI Mod (N970003/S199) | Boston Scientific Corp | 2016-12-12 |
| AUTOGEN EL ICD MODELS D160, D161, D162, D163. (P960040/S374) | Boston Scientific | 2016-12-12 |
| ESTEEM (P090018/S032) | Envoy Medical Corporation | 2016-12-12 |
| SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P150003/S026) | Boston Scientific Corporation | 2016-12-12 |
| PROMUS(ELEMENT PLUS /PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S136) | Boston Scientific Corp | 2016-12-12 |
| INVIVE CRT-P Models V172, V173; INTUA CRT-P Models V272, V273; VALITUDE Model U125; VALITUDE X4 Model U128; (P030005/S147) | Guidant Corp. | 2016-12-12 |
| ARISTA AH ABSORBABLE HEMOSTAT (P050038/S030) | Davol, Inc. | 2016-12-12 |
| CollaCote/ CollaTape/ CollePlug/Absorbable Collegen Wound Dressings (P840062/S058) | Integra Lifesciences Corp. | 2016-12-11 |
| AMS 800 URINARY CONTROL SYSTEMS, AMS 800 URINARY CONTROL SYSTEM WITH INHIBIZONE TREATMENT (P000053/S067) | Boston Scientific Corp | 2016-12-09 |
| ABBOTT ARCHITECT AUSAB (P050051/S032) | Abbott Laboratories, Inc. | 2016-12-09 |