| MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM FOR BOWEL (P080025/S116) | Medtronic Neuromodulation | 2016-08-05 |
| MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL (P970004/S221) | Medtronic Neuromodulation | 2016-08-05 |
| COBAS® AMPLIPREP/COBAS® TAQMAN® CMV TEST (CAP/CTM CMV TEST) (P110037/S027) | Roche Molecular Systems, Inc. | 2016-08-04 |
| AMPLATZER MUSCULAR VSD OCCLUDER (P040040/S029) | ABBOTT MEDICAL | 2016-08-04 |
| IN.PACT ADMIRAL PACLITAXEL-COATED BALLOON CATHETER (P140010/S022) | Medtronic, Inc. | 2016-08-04 |
| AMPLATZER Duct Occluder and AMPLATZER Duct Occluder II (P020024/S046) | ABBOTT MEDICAL | 2016-08-04 |
| AMPLATZER Septal Occluder and AMPLATZER Multi-Fenestrated Septal Occluder (P000039/S056) | ABBOTT MEDICAL | 2016-08-04 |
| SMARTABLATE SYSTEM: SMARTABLATE RF GENERATOR AND REMOTE CONTROL, SMARTABLATE SYSTEM: SMARTABLATE IRRIGATION PUMP (P990071/S033) | Biosense Webster, Inc. | 2016-08-04 |
| OPEN PIVOT HEART VALVE & OPEN PIVOT AORTIC VALVED GRAFT (P990046/S047) | Medtronic Ats Medical, Inc. | 2016-08-04 |
| COBAS HCV TEST (P150015/S003) | Roche Molecular Systems, Inc. | 2016-08-04 |
| COBAS HBV TEST (P150014/S003) | Roche Molecular Systems, Inc. | 2016-08-04 |
| WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE (LAAC) DEVICE (P130013/S009) | Boston Scientific Corp | 2016-08-04 |
| COBAS EGFR MUTATION TEST (P120019/S010) | Roche | 2016-08-04 |
| COBAS AMPLICOR HCV (P000012/S056) | Roche Molecular Systems, Inc. | 2016-08-04 |
| COBAS 4800 BRAF V600 MUTATION TEST (P110020/S017) | Roche Molecular Systems, Inc. | 2016-08-04 |
| COBAS KRAS MUTATION TEST (P140023/S006) | Roche Molecular Systems, Inc. | 2016-08-04 |
| COBAS TAQMAN HCV (P060030/S052) | Roche Molecular Systems, Inc. | 2016-08-04 |
| COBAS TAQMAN HBV TEST (P050028/S052) | Roche Molecular Systems, Inc. | 2016-08-04 |
| LIFEVEST WEARABLE DEFIBRILLATOR (WCD) 4000 (P010030/S079) | Zoll Manufacturing Corporation | 2016-08-03 |
| AMS 700 INFLATABLE PENILE PROSTHESIS (IPP) WITH INHIBIZONE (N970012/S117) | Boston Scientific Corp | 2016-08-03 |
| TACTICATH QUARTZ SET (P130026/S021) | St Jude Medical | 2016-08-03 |
| INSPIRE II IMPLANTABLE PULSE GENERATOR (P130008/S014) | Inspire Medical Systems | 2016-08-03 |
| AMS 800 URINARY CONTROL SYSTEM WITH INHIBIZONE (P000053/S066) | Boston Scientific Corp | 2016-08-03 |
| LIVEWIRE(R) CARDIAC ABLATION SYSTEM (P960016/S064) | St Jude Medical | 2016-08-02 |
| ENDOTAK RELIANCE 4-SITE LEADS PASSIVE FIXATION & ENDOTAK RELIANCE 4-SITE ACTIVE FIXATION (P910073/S137) | Boston Scientific | 2016-08-02 |
| DYNAGEN, INOGEN, ORIGEN ICD'S (P960040/S377) | Boston Scientific | 2016-08-02 |
| ESSENTIO, PROPONENT, ACCOLADE,ALTRUA 2 PACEMAKER'S (N970003/S191) | Boston Scientific Corp | 2016-08-02 |
| EMBLEM S-ICD SYSTEM (P110042/S061) | Boston Scientific Corporation | 2016-08-02 |
| ACUITY X4 STRAIGHT, SPIRAL, SPIRAL L ; DYNAGEN, INOGEN, ORIGEN CRT-D'S (P010012/S428) | Boston Scientific Corp | 2016-08-02 |
| ADHERUS AUTOSPRAY DURAL SEALANT (P130014/S002) | Stryker Leibinger GmbH & Co KG | 2016-08-02 |
| VALITUDE CRT-P (P030005/S139) | Guidant Corp. | 2016-08-02 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES (P130009/S061) | Edwards Lifesciences, LLC | 2016-08-02 |
| ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI PACEMAKER'S (P150012/S011) | Boston Scientific | 2016-08-02 |
| DEXCOM G5 Mobile Continuous Glucose Monitoring System (P120005/S048) | Dexcom, Inc. | 2016-08-02 |
| FINELINE II (P960004/S077) | Boston Scientific | 2016-08-02 |
| EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM ,EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM (P110023/S020) | Medtronic Vascular, Inc. | 2016-08-02 |
| SJM BIOCOR VALVE / SJM BIOCOR SUPRA VALVE (P040021/S028) | ABBOTT MEDICAL | 2016-08-01 |
| VASCADE VASCULAR CLOSURE SYSTEM (P120016/S020) | Cardiva Medical, Inc. | 2016-08-01 |
| DYNAGEN CRT-D: G150, G151, G154; DYNAGEN X4 CRT-D: G156, G158; INOGEN CRT-D: G140, G141; INOGEN X4 CRT-D: G146, G148 (P010012/S429) | Boston Scientific Corp | 2016-08-01 |
| ESTEEM (P090018/S031) | Envoy Medical Corporation | 2016-08-01 |
| QUARTET CRT LEADS (P030054/S308) | ABBOTT MEDICAL | 2016-08-01 |
| PROMRI ICD/CRT-D SYSTEM (P050023/S100) | Biotronik, Inc. | 2016-08-01 |
| DYNAGEN EL ICD: D150, D151, D152, D153; INOGEN EL ICD: D140, D141, D142, D143; ORIGEN EL ICD: D050, D051, D052, D053; (P960040/S378) | Boston Scientific | 2016-08-01 |
| SENSAR SOFT ACRYLIC INTRAOCULAR LENS (P980040/S071) | Johnson & Johnson Surgical Vision, Inc. | 2016-07-29 |
| SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM(OVER-THE-WIRE& MONORAIL) (P150003/S003) | Boston Scientific Corporation | 2016-07-29 |
| PRECISION, SPECTRA, NOVI, SPINAL CORD STIMULATION(SCS) SYSTEM; PRECISION MONTAGE MRI AND MONTAGE SPINAL CORD STIMULATOR (P030017/S254) | Boston Scientific Corp | 2016-07-29 |
| TECNIS CL FOLDABLE SILICONE INTRAOCULAR LENS (P880081/S040) | Johnson & Johnson Surgical Vision, Inc. | 2016-07-29 |
| TECNIS ACRYLIC INTRAOCULAR LENS (P990080/S043) | Johnson & Johnson Surgical Vision, Inc. | 2016-07-29 |
| RADIESSE 1.5cc (P050037/S075) | Merz North America, Inc. | 2016-07-29 |
| Activa Deep Brain Stimulation Therapy System (P960009/S257) | Medtronic, Inc. | 2016-07-29 |
| VALIANT THORACIC STENT GRAFT WITH CAPTIVIA DELIVERY SYSTEM (P100040/S026) | Medtronic Vascular | 2016-07-29 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S135) | W. L. Gore & Associates, Inc. | 2016-07-29 |
| VNS THERAPY SYSTEM (P970003/S201) | LivaNova USA, Inc. | 2016-07-29 |
| Restore, Itrel, and Synergy Spinal Cord Stimulation System and Pisces, Specify and Vectris Spinal Cord Stimulation Lead (P840001/S335) | Medtronic Neuromodulation | 2016-07-29 |
| RADIESSE 0.8cc and 1.5cc (P050052/S087) | Merz North America, Inc. | 2016-07-29 |
| CyPass Micro-Stent (P150037) | Alcon Research, Ltd. | 2016-07-29 |
| FREEZOR CARDIAC CRYOABLATION CATHETER, FREEZOR XTRA SURGICAL CATHETERS, FREEZOR MAX SURGICAL CATHETER (P020045/S075) | Medtronic Cryocath, LP | 2016-07-29 |
| ARCTIC FRONT CARDIAC CRYOABLATION CATHETER, ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER, ARCTIC FRONT ST CARDIAC (P100010/S056) | Medtronic Cryocath, LP | 2016-07-29 |
| Micra Transcatheter Pacing System MC1VR01 (P150033/S004) | Medtronic, Inc. | 2016-07-28 |
| Evera MRI ICD DDMB1D4, DDMC3D4, DVMB1D4, DVMC3D4; Visia AF MRI VR ICD DVFB1D4, DVFC3D4; Visia AF VR ICD DVAB1D1, DVAB1D4 (P980016/S595) | Medtronic Cardiac Rhythm Disease Management | 2016-07-28 |
| Pulse, PulseDuo, DemiPulse, DemiPulseDuo, AspireHC, Aspire SR Generators. (P970003/S197) | LivaNova USA, Inc. | 2016-07-28 |
| SYNCHROMED II INFUSION SYSTEM (P860004/S256) | Medtronic, Inc. | 2016-07-28 |
| PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S245) | Boston Scientific Corp | 2016-07-28 |
| PRECISION SPINAL CORD, SPECTRA, NOVI, MONTAGE MRI & PRECISION MONTAGE SPINAL CORD STIMULATION(SCS) SYSTEMS (P030017/S253) | Boston Scientific Corp | 2016-07-28 |
| NEUROPACE RNS SYSTEM (P100026/S043) | NeuroPace, Inc. | 2016-07-28 |
| Amplia MRI CRT-D DTMB1D4; Amplia MRI Quad CRT-D DTMB1QQ; Compia MRI CRT-D DTMC1D4; Compia MRI Quad CRT-D DTMC1QQ (P010031/S556) | Medtronic Cardiac Rhythm Disease Management | 2016-07-28 |
| CRYSTALENS ACCOMMODATING INTRAOCULAR LENS & TRULIGN TORIC INTRAOCULAR LENS (P030002/S038) | Bausch & Lomb, Inc. | 2016-07-27 |
| INTERSTIM THERAPY SYSTEM (P970004/S219) | Medtronic Neuromodulation | 2016-07-27 |
| Iperia 7 HF-T (DF-1) Iperia 7 HF-T (DF4) Inventra 7 HF-T (DF-1) Inventra 7 HF-T (DF4) Defibrillator, Automatic Implantab (P050023/S102) | Biotronik, Inc. | 2016-07-27 |
| GORE TIGRIS VASCULAR STENT (P160004) | W. L. Gore & Associates, Inc. | 2016-07-27 |
| TRIDYNE VASCULAR SEALANT (P150016/S001) | Neomend, Inc. | 2016-07-27 |
| Activa Deep Brain Stimulation Therapy System (P960009/S255) | Medtronic, Inc. | 2016-07-27 |
| Restore, ltrel, and Synergy Spinal Cord Stimulation Systems and Pisces, Resume, Specify, and Vectris Spinal Cord Stimula (P840001/S333) | Medtronic Neuromodulation | 2016-07-27 |
| PARADIGM REAL-TIME REVEL SYSTEM (P150019/S007) | Medtronic Minimed | 2016-07-27 |
| VENASEAL CLOSURE SYSTEM (P140018/S002) | Medtronic Vascular, Inc. | 2016-07-27 |
| INTERSTIM THERAPY SYSTEM (P080025/S114) | Medtronic Neuromodulation | 2016-07-27 |
| SYNCHROMED(TM) INFUSION SYSTEM (P860004/S254) | Medtronic, Inc. | 2016-07-27 |
| INGEVITY MRI LEAD, INGEVITY Non-MRI Lead (P150012/S010) | Boston Scientific | 2016-07-26 |
| BETA-CATH (TM) SYSTEM (P000018/S047) | Best Vascular, Inc. | 2016-07-26 |
| BIOCOR VALVE, SUPRA VALVE; EPIC VALVE, SUPRA VALVE; TRIFECTA VALVE, TRIFECTA VALVE WITH GLIDE TECHONOLOGY (TRIFECTA GT) (P100029/S022) | ABBOTT MEDICAL | 2016-07-26 |
| COLOGUARD (P130017/S011) | Exact Sciences Corporation | 2016-07-26 |
| CELLUGEL(R) OPHTHALMIC VISCOSURGICAL DEVICE (P990023/S015) | Alcon Laboratories | 2016-07-26 |
| Solia S 45, 53, 60 Siello S 45, 53, 60 Drug-Eluting Permanent Right Ventricular (RV) or Right Atrial (RA) Pacemaker Elec (P950037/S165) | Biotronik, Inc. | 2016-07-26 |
| RADIESSE 1.5CC (P050037/S074) | Merz North America, Inc. | 2016-07-26 |
| RADIESSE 0.8cc (P050052/S086) | Merz North America, Inc. | 2016-07-26 |
| BRACANALYSIS CDX (P140020/S002) | Myriad Genetic Laboratories | 2016-07-26 |
| BIOCOR VALVE, SUPRA VALVE; EPIC VALVE, SUPRA VALVE; TRIFECTA VALVE, TRIFECTA VALVE WITH GLIDE TECHONOLOGY (TRIFECTA GT) (P040021/S029) | ABBOTT MEDICAL | 2016-07-26 |
| ELECSYS ANTI-HCV II TEST SYSTEM (P140021/S005) | Roche Diagnostics Operations, Inc. | 2016-07-25 |
| INGEVITY LEAD (P150012/S009) | Boston Scientific | 2016-07-25 |
| CURRENT, CURRENT ACCEL, CURRENT+, ELLIPSE, FORTIFY, FORTIFY ASSURA, EPIC/EPIC+, ATLAS/II/+ FAMILY OF ICD'S (P910023/S372) | ABBOTT MEDICAL | 2016-07-25 |
| GEL-ONE (P080020/S021) | Seikagaku Corp. | 2016-07-25 |
| ACUITY SPIRAL LEAD, ACUITY X4 LEAD (P010012/S425) | Boston Scientific Corp | 2016-07-25 |
| ANTHEM, ALLURE/RF, ALLURE QUADRA/RF FAMILY OF CRT-P'S (P030035/S147) | ABBOTT MEDICAL | 2016-07-25 |
| ON-X PROSTHETIC HEART VALVE and On-X Ascending Aortic Prothesis (P000037/S046) | On-X Life Technologies, Inc. | 2016-07-25 |
| CARDIOMEMS HF SYSTEM (P100045/S009) | ABBOTT MEDICAL | 2016-07-25 |
| ASSURITY, ASSURITY+, ENDURITY, ACCENT FAMILY OF PACEMAKERS (P880086/S273) | ABBOTT MEDICAL | 2016-07-25 |
| ENDOTAK RELIANCE IS-1 and ENDOTAK RELIANCE 4-SITE LEAD (P910073/S136) | Boston Scientific | 2016-07-25 |
| PROMOTE/+/RF/Q, PROMOTE ACCEL, PROMOTE QUADRA, UNIFY, UNIFY ASSURA, UNIFY QUADRA, QUADRA ASSURA, EPIC+/HF/HF+/II HF/II+ (P030054/S304) | ABBOTT MEDICAL | 2016-07-25 |
| BOSTON EQUALENS, EQUALENS II (ITAFLUROFOCON A)& (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS (P860022/S059) | Bausch & Lomb | 2016-07-25 |
| SUPARTZ Device Family, Supartz FX, VISCO-3 (P980044/S033) | Seikagaku Corp. | 2016-07-25 |