| BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS FOR OVERNIGHT WEAR AND VISION SHAPING TREATMENT (P010062/S010) | Bausch & Lomb | 2016-07-25 |
| Dynagen Models: G150, G151, G154, G156, G158; Inogen Models: G140, G141, G146, G148; Origen (P010012/S426) | Boston Scientific Corp | 2016-07-22 |
| SYNCHROMED II IMPLANTABLE INFUSION PUMP (P860004/S243) | Medtronic, Inc. | 2016-07-22 |
| REFLECTION CERAMIC ACETABULAR HIP SYSTEM (P030022/S036) | Smith & Nephew, Inc. | 2016-07-22 |
| Dynagen Models: D020, D021, D022, D023; D150, D151, D152, D153; Inogen Models: D010, D011, D012, D013, D140, D141, D14 (P960040/S375) | Boston Scientific | 2016-07-22 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S059) | Medtronic Vascular | 2016-07-22 |
| HERCEPTEST (P980018/S022) | Agilent Technologies Singapore (International) Pte , Ltd. | 2016-07-22 |
| SCULPTRA AND SCULPTRA AESTHETIC (P030050/S025) | Q-Med AB | 2016-07-22 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S073) | Medtronic Vascular | 2016-07-21 |
| Edwards Expandable Introducer Sheath Set (P130009/S063) | Edwards Lifesciences, LLC | 2016-07-21 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S078) | Zoll Manufacturing Corporation | 2016-07-21 |
| RESURE SEALANT (P130004/S002) | Ocular Therapeutix, Inc. | 2016-07-21 |
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S148) | Cochlear Americas | 2016-07-21 |
| NUCLEUS AUDITORY BRAINSTEM IMPLANT (P000015/S014) | Cochlear Americas | 2016-07-21 |
| NOVATION CERAMIC ARTICULATION HIP SYSTEM (P050039/S019) | Exactech, Inc. | 2016-07-21 |
| ACTIVA Deep Brain Stimulation Therapy System (P960009/S256) | Medtronic, Inc. | 2016-07-20 |
| INTERSTIM THERAPY SYSTEM (P080025/S115) | Medtronic Neuromodulation | 2016-07-20 |
| T:SLIM G4TM INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM (P140015/S010) | Tandem Diabetes Care, Inc. | 2016-07-20 |
| MEDTRONIC(R) SYNCHROMED(TM) PUMP & INFUSION SYSTEM (P860004/S255) | Medtronic, Inc. | 2016-07-20 |
| REVO MRI SURESCAN IPG (P090013/S228) | Medtronic, Inc. | 2016-07-20 |
| CELT ACD VASCULAR CLOSURE DEVICE (P150006) | Vasorum, Ltd. | 2016-07-20 |
| CONSULTA, SYNCRA, VIVA CRT-P (P010015/S302) | Medtronic, Inc. | 2016-07-20 |
| EPIC VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S034) | Boston Scientific Corp | 2016-07-20 |
| ADVISA DR IPG; DR MRI IPG; SR MRI IPG (P980035/S467) | Medtronic, Inc. | 2016-07-20 |
| PRESTIGE® Cervical Disc (P060018/S004) | Medtronic Sofamor Danek, Inc. | 2016-07-20 |
| FALOPE-RING BAND CONTRACEPTIVE TUBAL OCCLUSION SYSTEM (P870076/S017) | Gyrus Acmi, Inc. | 2016-07-20 |
| INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL (P970004/S220) | Medtronic Neuromodulation | 2016-07-20 |
| Restore, Itrel, and Synergy Spinal Cord Stimulation Systems and Pisces, Resume,Specify, and Vectris Spinal Cord Stimulat (P840001/S334) | Medtronic Neuromodulation | 2016-07-20 |
| TENDRIL SDX, TENDRIL ST, TENDRIL STS, OPTISENSE (P960013/S082) | ABBOTT MEDICAL | 2016-07-19 |
| DURATA, OPTISURE (P950022/S093) | ABBOTT MEDICAL | 2016-07-19 |
| AIR OPTIX PLUS HYDRAGLYDE; AIR OPTIX PLUS HYDRAGLYDE FOR ASTIGMATISM; AIR OPTIX PLUS HYDRAGLYDE MULTIFOCAL; AIR OPTIX PL (P010019/S050) | Alcon Laboratories, Inc. | 2016-07-19 |
| ISOFLEX OPTIM (P960030/S045) | ABBOTT MEDICAL | 2016-07-19 |
| QUICKFLEX u, QUARTET (P030054/S305) | ABBOTT MEDICAL | 2016-07-19 |
| ENROUTE TRANSCAROTID STENT SYSTEM (P140026/S002) | Boston Scientific Corporation | 2016-07-19 |
| Current+ ICDS (P910023/S374) | ABBOTT MEDICAL | 2016-07-19 |
| Promote + ICDS (P030054/S306) | ABBOTT MEDICAL | 2016-07-19 |
| CORDIS PALMAZ BALLOON-EXPANDABLE STENT (P890017/S017) | Cordis US Corporation | 2016-07-18 |
| WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 4000 LIFEVEST (P010030/S074) | Zoll Manufacturing Corporation | 2016-07-18 |
| THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER (P040036/S056) | Biosense Webster, Inc. | 2016-07-18 |
| SILIKON 1000 (P950008/S013) | Alcon | 2016-07-18 |
| ThermoCool SmartTouch Uni-Directional Navigation Catheter (P030031/S075) | Biosense Webster, Inc. | 2016-07-18 |
| MEDTRONIC MICRA TRANSCATHETER PACING SYSTEM (P150033/S003) | Medtronic, Inc. | 2016-07-18 |
| DURASEAL EXACT SPINE SEALANT SYSTEM (P080013/S013) | Integra LifeSciences Corporation | 2016-07-15 |
| PROMUS(ELEMENT PLUS/PREMIER) EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S122) | Boston Scientific Corp | 2016-07-15 |
| DURASEAL DURAL SEALANT SYSTEM (P040034/S025) | Integra LifeSciences Corporation | 2016-07-15 |
| TECNIS SYMFONY EXTENDED RANGE OF VISION INTRAOCULAR LENS (P980040/S065) | Johnson & Johnson Surgical Vision, Inc. | 2016-07-15 |
| HIRESOLUTION BIONIC EAR SYSTEM, HIRES ULTRA COCHLEAR IMPLANT WITH THE HIFOCUS MID-SCALA ELECTRODE (P960058/S117) | Advanced Bionics | 2016-07-15 |
| ALGOVITA SPINAL CORD STIMULATION SYSTEM (P130028/S009) | Nuvectra Corporation | 2016-07-14 |
| CAPSURE VDD 2 LEAD, SERVICE KIT-PACEMAKER REPAIR KIT, VITATRON BRILLIANT S+ VDD LEAD (P890003/S359) | Medtronic, Inc. | 2016-07-14 |
| ATTAIN BIPOLAR OTW LEAD, ATTAIN OTW LV LEAD, CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P (P010015/S303) | Medtronic, Inc. | 2016-07-14 |
| TRANSVENE CS/SVC LEAD (P980050/S105) | Medtronic, Inc. | 2016-07-14 |
| AMPLIA/BRAVA/CONCERTO/INSYNC SENTRY/INSYNC MAXIMO/PROTECTA/VIVA IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC R (P010031/S555) | Medtronic Cardiac Rhythm Disease Management | 2016-07-14 |
| SENZA SPINAL CORD STIMULATION (SCS) SYSTEM (P130022/S008) | Nevro Corporation | 2016-07-14 |
| CAPSUREFIX LEAD, CAPSUREFIX NOVUS LEAD, VITATRON CRYSTALLINE ACTIVE FIXATION LEAD (P930039/S153) | Medtronic, Inc. | 2016-07-14 |
| SELECTSECURE LEAD (P030036/S085) | Medtronic Cardiac Rhythm Disease Management | 2016-07-14 |
| ADAPTA, VERSA, SENSIA IPG; ADVISA DR IPG; ADVISA DR MRI IPG; ADVISA SR MRI IPG; RELIA IPG (P980035/S468) | Medtronic, Inc. | 2016-07-14 |
| MEDTRONIC ATTAIN ABILITY MODEL 4196 LEAD; ATTAIN PERFORMA LEAD (P080006/S096) | Medtronic, Inc. | 2016-07-14 |
| ATTAIN STARFIX MODEL 4195 LEAD (P060039/S071) | Medtronic, Inc. | 2016-07-14 |
| Y ADAPTOR/EXTENDER KIT, DF-1 CONNECTOR PORT PIN PLUG KIT, LEAD ADAPTOR, SUBCUTANEOUS LEAD, TRANSVENE CS/SVC LEAD, TUNNEL (P920015/S181) | Medtronic, Inc. | 2016-07-14 |
| END CAP, UPSIZING SLEEVE (P900061/S140) | Medtronic Cardiac Rhythm Disease Management | 2016-07-14 |
| MITROFLOW AORTIC PERICARDIAL HEART VALVE (P060038/S028) | Corcym Canada Corp | 2016-07-14 |
| ADHESIVE, CAPSURE SENSE LEAD, CAPSURE SP NOVUS LEAD, VITATRON CRYSTALLINE LEAD, VITATRON EXCELLENCE PS+ LEAD (P830061/S131) | Medtronic Cardiac Rhythm Disease Management | 2016-07-14 |
| CAPSURE SP NOVUS LEAD, CAPSURE SP Z LEAD, CAPSURE Z NOVUS LEAD, VITATRON IMPULSE II LEAD (P850089/S118) | Medtronic Cardiac Rhythm Disease Management | 2016-07-14 |
| CAPSURE EPICARDIAL PACING LEAD (P950024/S068) | Medtronic, Inc. | 2016-07-14 |
| REVO MRI SURESCAN IPG AND CAPSUREFIX MRI LEAD (P090013/S229) | Medtronic, Inc. | 2016-07-14 |
| MYOCARDIAL PACING LEAD (P120017/S004) | Medtronic, Inc. | 2016-07-14 |
| EVERA MRI/EVERA S DR/EVERA S VR/EVERA XT DR/EVERA XT VR/MAXIMO II/PROTECTA/PROTECTA VR/PROTECTA XT/SECURA DR/SECURA/VIRT (P980016/S594) | Medtronic Cardiac Rhythm Disease Management | 2016-07-14 |
| INGENIO 2 MRI PACEMAKERS. (P150012/S004) | Boston Scientific | 2016-07-14 |
| OPTUNE (P100034/S015) | Novocure, GmbH | 2016-07-13 |
| VYSIS ALK BREAK APART FISH PROBE KIT (P110012/S010) | Abbott Molecular, Inc. | 2016-07-13 |
| ALGOVITA SPINAL CORD STIMULATION SYSTEM (P130028/S010) | Nuvectra Corporation | 2016-07-13 |
| ABBOTT ARCHITECT AUSAB (P050051/S031) | Abbott Laboratories, Inc. | 2016-07-13 |
| MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL (P970004/S217) | Medtronic Neuromodulation | 2016-07-13 |
| MEDTRONIC INTERSTIM THERAPY SYSTEM FOR BOWEL (P080025/S112) | Medtronic Neuromodulation | 2016-07-13 |
| XACT CAROTID STENT SYSTEM (P040038/S031) | Abbott Vascular, Inc. | 2016-07-13 |
| SUPERA PERIPHERAL STENT SYSTEM (P120020/S013) | Abbott Vascular (Idef Technologies Inc) | 2016-07-13 |
| EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S074) | Boston Scientific Corp | 2016-07-13 |
| ACUITY X4 LEAD (P150012/S006) | Boston Scientific | 2016-07-13 |
| INGEVITY LEAD (P010012/S420) | Boston Scientific Corp | 2016-07-13 |
| VNS THERAPY SYSTEM (P970003/S196) | LivaNova USA, Inc. | 2016-07-13 |
| MEDTRONIC ATTAIN ABILITY MODEL 4196 LEAD (P080006/S095) | Medtronic, Inc. | 2016-07-13 |
| PATH VYSION HER-2 DNA PROBE KIT (P980024/S014) | Abbott Molecular, Inc. | 2016-07-13 |
| EXPRESS LD ILIAC OVER-THE-WIRE PREMOUNTED STENT SYSTEM (P090003/S041) | Boston Scientific Corporation | 2016-07-13 |
| EXABLATE (P150038) | Insightec | 2016-07-11 |
| GORE EXCLUDER ILIAC BRANCH ENDOPROSTHESIS (P020004/S133) | W. L. Gore & Associates, Inc. | 2016-07-11 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S134) | W. L. Gore & Associates, Inc. | 2016-07-11 |
| LATITUDE NXT RELEASE 4.1.1 (P910077/S152) | Boston Scientific | 2016-07-08 |
| CRT-D RESYNCHRONIZATION DEVICES, COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN (P010012/S417) | Boston Scientific Corp | 2016-07-08 |
| NUCLEUS HYBRID COCHLEAR IMPLANT SYSTEM (P130016/S012) | Cochlear Americas | 2016-07-08 |
| T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM (P140015/S009) | Tandem Diabetes Care, Inc. | 2016-07-08 |
| ICD DEVICES: TELIGEN, ENERGEN, PUNCTUA, INCEPTA, OPRIGEN, INOGEN, DYNAGEN, AUTOGEN. (P960040/S370) | Boston Scientific | 2016-07-08 |
| NUCLEUS COCHLEAR IMPLANT SYSTEM (P970051/S137) | Cochlear Americas | 2016-07-08 |
| IN PACT ADMIRAL PACLITAXEL-COATED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER (P140010/S020) | Medtronic, Inc. | 2016-07-08 |
| MYCARELINK PATIENT MONITOR SYSTEM (P890003/S357) | Medtronic, Inc. | 2016-07-08 |
| COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S088) | Med-El Corp. | 2016-07-08 |
| DEXCOM G4 PLATINUM RECEIVER, G4 PLATINUM PEDIATRIC RECEIVER, DEXCOM G5 MOBILE RECEIVER, DEXCOM G4 PLATINUM RECEIVER WIT (P120005/S047) | Dexcom, Inc. | 2016-07-08 |
| MICRA (P150033/S002) | Medtronic, Inc. | 2016-07-08 |
| PACEMAKER DEVICES. ADVANTION, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT, (INSIGNIA AND ALTRUA 2 SUPPORTED (N970003/S187) | Boston Scientific Corp | 2016-07-08 |
| CRT-P RESYNCHRONIZATION DEVICES: INVIVE, INTUA, VISIONIST, VALITUDE (P030005/S134) | Guidant Corp. | 2016-07-08 |
| SUBCUTANEOUS ICD DEVICES: EMBLEM. (P110042/S059) | Boston Scientific Corporation | 2016-07-08 |