| JUVEDERM HYALURONATE GEL IMPLANTS (P050047/S051) | Allergan | 2015-10-23 |
| EVERA MRI ICD,EVERA S DR ICD,EVERA S VR ICD,EVERA XT DR ICD,EVERA XT ICD,MAXIMO II ICD, PROTECTA ICD, PROTECT XT ICD,SEC (P980016/S552) | Medtronic Cardiac Rhythm Disease Management | 2015-10-23 |
| EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S070) | Boston Scientific Corp | 2015-10-23 |
| INNOVA (TM) VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM (P140028/S003) | Boston Scientific Corporation | 2015-10-23 |
| DEXCOM G4TM PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM; DEXCON G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S039) | Dexcom, Inc. | 2015-10-23 |
| SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM (P030011/S033) | Syncardia Systems, LLC | 2015-10-22 |
| CONSULTA CRT-P, SYNCRA CTR-P (P010015/S282) | Medtronic, Inc. | 2015-10-22 |
| MELAFIND (P090012/S004) | Strata Skin Sciences, Inc. | 2015-10-22 |
| BRAVA CRT-D,BRAVA QUARD CRT-D,CONCERTO II CRT-D, CONSULTA CRT-D,MAXIMOII CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D, VIVA (P010031/S514) | Medtronic Cardiac Rhythm Disease Management | 2015-10-22 |
| XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S078) | Abbott Vascular | 2015-10-22 |
| REVO MRI SURESCAN IPG (P090013/S204) | Medtronic, Inc. | 2015-10-22 |
| XIENCE V AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S131) | Abbott Vascular, Inc. | 2015-10-22 |
| XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM, LL, XIENCE (P110019/S079) | Abbott Vascular | 2015-10-22 |
| PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S237) | Boston Scientific Corp | 2015-10-22 |
| HYDRELLE (P050033/S020) | Anika Therapeutics, Inc. | 2015-10-22 |
| EVERA MRI ICD, EVERA S DR ICD, EVERA XT DR ICD, EVERA XT VR ICD, MAXIMO II ICD, PROTECTS ICD, PROTECTS XT ICD, SECURA IC (P980016/S553) | Medtronic Cardiac Rhythm Disease Management | 2015-10-22 |
| ADAPTA, VERSA, SENSIA IPG, ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, ADVISA SR MRI IPG, RELIA IPG (P980035/S441) | Medtronic, Inc. | 2015-10-22 |
| MULTI-LINK VISION MULTI-LINK MINI-VISION AND MULTI-LINK 8 (P020047/S063) | Abbott Vascular | 2015-10-22 |
| NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S064) | Hologic, Inc. | 2015-10-22 |
| THERAPY COOL PATH, SAFIRE BLU, SAFIRE BLU SP, AND THERAPY COOL PATH SP ABLATION CATHETERS (P060019/S034) | Irvine Biomedical, Inc. | 2015-10-21 |
| GEN 2 S-ICD & SQ-RX PULSE GENERATOR, SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFRILLATOR (P110042/S052) | Boston Scientific Corporation | 2015-10-21 |
| TACTICATH QUARTZ CATHETER AND TACTISYSQUARTZ EQUIPMENT (P130026/S010) | St Jude Medical | 2015-10-21 |
| ACTIVL ARTIFICIAL DISC (P120024/S001) | Highridge Medical, LLC | 2015-10-21 |
| FLEXABILITY ABLATION CATHETER, THERAPY COOL PATH DUO, SAFIRE BLU DUO, COOL PATH DUO, SAFIRE DUO, THERAPY COOL PATH DUO (P110016/S023) | ABBOTT MEDICAL | 2015-10-21 |
| ANIMAS VIBE SYSTEM (P130007/S009) | Animas Corp. | 2015-10-21 |
| LIVEWIRE TC STEERABLE ELECTROPHYSIOLOGY CATHETER, SAFIRE BI-DIRECTIONAL ABLATION CATHETER (P960016/S057) | St Jude Medical | 2015-10-21 |
| THERAPY ABLATION CATHETERS (P040014/S027) | Irvine Biomedical, Inc. | 2015-10-21 |
| PUNCTUA, ENERGEN, INCEPTA, ORIGEN, INOGEN, DYNAGEN, CARDIAC RESYNHRONIZATION THERAPY-DEFIBRILLATOR (P010012/S402) | Boston Scientific Corp | 2015-10-21 |
| SYNCHROMED INFUSION SYSTEM (P860004/S237) | Medtronic, Inc. | 2015-10-21 |
| FREESTYLE AORTIC ROOT BIOPROSTHESIS (P970031/S050) | Medtronic, Inc. | 2015-10-21 |
| PUNCTUA, ENERGEN, INCEPTA, ORIGEN, INOGEN, DYNAGEN, IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (P960040/S357) | Boston Scientific | 2015-10-21 |
| THERAPY COOL PATH, SAFIRE BLU, SAFIRE BLU SP, AND THERAPY COOL PATH SP ABLATION CATHETERS (P040042/S032) | Irvine Biomedical,Inc.(Ibi) | 2015-10-21 |
| CVX-300/CVX300-P EXCIMER LASER SYSTEM (P910001/S078) | Spectranetics Corp. | 2015-10-20 |
| COMPLETE SE VASCULAR STENT SYSTEM- ILIAC (P090006/S016) | Medtronic Vascular | 2015-10-20 |
| COMPLETE SE VASCULAR STENT SYSTEM- SFA AND PPA (P110040/S008) | Medtronic Vascular | 2015-10-20 |
| LEGEND PLUS IPG (P930022/S017) | Medtronic, Inc. | 2015-10-19 |
| VITATRON C20 SR IPG,VITATRON C60 DR IPG,VITATRON T20 SR IPG,VITATRON T60 DR IPG (P990001/S119) | Medtronic, Inc. | 2015-10-19 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE; EDWARDS QUALCRIMP CRIMPING ACCESSORY (P130009/S004) | Edwards Lifesciences, LLC | 2015-10-19 |
| BRAVA,BRAVA QUAD,CONCERTO II,CONSULTA,MAXIMO II,PROTECTA,PROTECTA XT,VIVA QUAD S, VIVA QUAD XT,VIVA S, VIVA XT CRT-DS, C (P010031/S478) | Medtronic Cardiac Rhythm Disease Management | 2015-10-19 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P110021/S042) | Edwards Lifesciences, LLC | 2015-10-19 |
| CARPENTIER-EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS, THEON PERICARDIAL AOTIC BIOPROSTHESIS WITH THERMAFIX TISSUE PROCESS (P860057/S127) | Edwards Lifesciences, LLC | 2015-10-19 |
| ORIGEN EL ICD & MINI ICD, INOGEN EL ICD & MINI ICD; DYNAGEN EL ICD & MINI ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P960040/S356) | Boston Scientific | 2015-10-19 |
| KAPPA 400 DR IPG,KAPPA 400 SR IPG (P970012/S096) | Medtronic, Inc. | 2015-10-19 |
| JEWEL AF ICD (P980050/S097) | Medtronic, Inc. | 2015-10-19 |
| SYMBIOS,SYNERGYST IPGS (P820003/S132) | Medtronic Cardiac Rhythm Disease Management | 2015-10-19 |
| REVO MRI IPG (P090013/S165) | Medtronic, Inc. | 2015-10-19 |
| MEDTRONIC GEM ICD,MEDTRONIC JEWEL ICD,MEDTRONIC JEWEL PLUS ICD,MEDTRONIC MICRO JEWEL ICD,MEDTRONIC MICRO JEWEL II ICD,ME (P900061/S133) | Medtronic Cardiac Rhythm Disease Management | 2015-10-19 |
| SOFLENS TORIC (ALPHAFILCON A) VISIBILITY TINTED CONTACT LENS (P960022/S011) | Bausch & Lomb, Inc. | 2015-10-19 |
| EVERA S DR ICD, EVERA S VR ICD,EVERA XT DR ICD, EVERA XT VR ICD,GEM DR ICD,GEM II DR ICD, GEM II VR ICD,GEM III VR ICD,I (P980016/S514) | Medtronic Cardiac Rhythm Disease Management | 2015-10-19 |
| ELITE,ELITE II,MINUET,PREVA,PRODIGY,THERA D,THERA DR IPGS, THERA ID PG,THERA IPG,THERA S IPG,THERA SR IPG,THERA VDD IPG, (P890003/S326) | Medtronic, Inc. | 2015-10-19 |
| ACTIVITRAX II IPG,ACTIVITRAX IPG,LEGEND II IPG,LEGEND IPG,MICRO MINIX IPG,MINIX IPG,MINIX ST IPG,PREMIER IPG,PREVAIL IPG (P850051/S082) | Medtronic, Inc. | 2015-10-19 |
| EMBLEM S-ICD PULSE GENERATOR (P110042/S051) | Boston Scientific Corporation | 2015-10-19 |
| MEDTRONIC PCD TACHYARRHYTHMIA CONTROL SYSTEM (P920015/S146) | Medtronic, Inc. | 2015-10-19 |
| HEARTMATE II LVAS SYSTEM (P060040/S046) | ABBOTT MEDICAL | 2015-10-19 |
| CONSULTA,SYNCRA,VIVA CRT-PS,INSYNC IPG (P010015/S255) | Medtronic, Inc. | 2015-10-19 |
| EDWARDS SAPIEN TRANSCATHER HEART VALVE (P100041/S055) | Edwards Lifesciences, LLC | 2015-10-19 |
| ADAPTA,VERSA,SENSIA IPG,ADVISA DR IPG,ADVISA DR MRI IPG,AT500 DDDRP PACING SYSTEM IPG, ENPULSE E2 IPG,ENPULSE E2 IPG,KAP (P980035/S404) | Medtronic, Inc. | 2015-10-19 |
| ORIGEN CRT-D, X4 CRT-D, INOGEN CRT-D, X4 CRT-D; DYNAGEN CRT-D, X4 CRT-D CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATORS (P010012/S401) | Boston Scientific Corp | 2015-10-19 |
| PARASCRIPT (R) ACCUDETECT (R) (P120004/S001) | Parascript, LLC | 2015-10-16 |
| TALENT OCCLUDER WITH OCCLUDER DELIVERY SYSTEM (P070027/S045) | Medtronic Vascular | 2015-10-15 |
| RAYNER C-FLEX 570C, C-FLEX ASPHERIC 970C AND 600C ASPHERIC INTRAOCULAR LENSES (P060011/S007) | Rayner Intraocular Lenses , Ltd. | 2015-10-15 |
| ALLEGRETTO WAVE EYE-Q (P020050/S024) | Alcon Laboratories, Inc. | 2015-10-15 |
| ORAQUICK HCV RAPID ANTIBODY TEST (P080027/S021) | OraSure Technologies, Inc. | 2015-10-15 |
| MITRACLIP CLIP DELIVERY SYSTEM (P100009/S013) | ABBOTT MEDICAL | 2015-10-15 |
| COBAS AMPLICOR HCV TEST VERSION 2.0 (P000012/S054) | Roche Molecular Systems, Inc. | 2015-10-15 |
| VISTAKON (ETAFILCON A) BRAND CONTACT LENSES (N18033/S079) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2015-10-15 |
| NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S065) | Hologic, Inc. | 2015-10-15 |
| IN.PACT ADMIRAL PACLITAXEL-COATED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER (P140010/S010) | Medtronic, Inc. | 2015-10-15 |
| TRIPOLE, TRIPOLE 16C, TRIPOLE 16, LAMITRODE 4, LAMITRODE 44, LAMITRODE S-4, LAMITRODE S-8, LAMITRODE 88, LAMITRODE WINGE (P010032/S101) | ABBOTT MEDICAL | 2015-10-15 |
| METHAFILCON A AND B SOFT (HYDROPHILIC) EXTENDED WEAR CONTACT LENSES (P850079/S068) | CooperVision, Inc. | 2015-10-15 |
| TSLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM SYSTEM (P140015/S005) | Tandem Diabetes Care, Inc. | 2015-10-15 |
| INVENIA ABUS -- AUTOMATED BREAST ULTRASOUND SYSTEM (P110006/S006) | GE Healthcare | 2015-10-15 |
| THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) (P060040/S044) | ABBOTT MEDICAL | 2015-10-14 |
| COBAS HCV TEST (P150015) | Roche Molecular Systems, Inc. | 2015-10-14 |
| ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S238) | Medtronic, Inc. | 2015-10-14 |
| AMS 700 AMBICOR INFLATABLE PENILE PROTHESIS (N970012/S113) | Boston Scientific Corp | 2015-10-14 |
| AMS 800 URINARY CONTROL SYSTEM (P000053/S061) | Boston Scientific Corp | 2015-10-14 |
| RESTORE, ITREL, AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES, RESUME, SPECIFY, AND VECTRIS SPINAL CORD STIMULA (P840001/S313) | Medtronic Neuromodulation | 2015-10-14 |
| COBAS HBV TEST (P150014) | Roche Molecular Systems, Inc. | 2015-10-14 |
| COCHLEAR IMPLANT (P970051/S134) | Cochlear Americas | 2015-10-14 |
| GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P040037/S081) | W. L. Gore & Associates, Inc. | 2015-10-14 |
| GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P130006/S020) | W. L. Gore & Associates, Inc. | 2015-10-14 |
| EVERA MRI XT DR SURESCAN ICD, EVERA MRI XT VR SURESCAN ICD,EVERA MRI S DR SURESCAN ICD, EVERA MRI S VR SURESCAN ICD (P980016/S549) | Medtronic Cardiac Rhythm Disease Management | 2015-10-14 |
| FINELINE II STEROX IMPLANTABLE CARDIAC ENDOCARDIAL PACING LEADS (P960004/S074) | Boston Scientific | 2015-10-13 |
| ROTABLATOR ROTATIONAL ANGOPLASTY SYSTEM GUIDEWIRE (P900056/S151) | Boston Scientific Corp | 2015-10-13 |
| CHILLI II COOLED ABLATION CATHETER AND CABLE (P980003/S064) | Boston Scientific Corp | 2015-10-13 |
| 3F AORTIC BIOPROSTHESIS (P060025/S014) | Medtronic, Inc. | 2015-10-13 |
| BLAZER II XP CARDIAC ABLATION CATHETER AND CABLE (P020025/S080) | Boston Scientific | 2015-10-13 |
| LOTRAFILCON A AND LOTRAFILCON B SOFT CONTACT LENSES FOR EXTENDED WEAR (P010019/S041) | Alcon Laboratories, Inc. | 2015-10-13 |
| BLAZER II CARDIAC ABLATION CATHETER AND CABLE (P920047/S086) | Boston Scientific Corp | 2015-10-13 |
| MITROFLOW AORTIC PERICARDIAL HEART VALVE (P060038/S025) | Corcym Canada Corp | 2015-10-12 |
| ABBOTT REALTIME HCV (P100017/S014) | Abbott Molecular, Inc. | 2015-10-09 |
| ABBOTT REALTIME HBV (P080026/S016) | Abbott Molecular, Inc. | 2015-10-09 |
| ABBOTT REALTIME HCV GENOTYPE II (P120012/S009) | Abbott Molecular | 2015-10-09 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES (P130009/S034) | Edwards Lifesciences, LLC | 2015-10-09 |
| PERCLOSE PROGLIDE SUTURE-MEDIATED CLOSURE DEVICE (P960043/S090) | Abbott Vascular, Inc. | 2015-10-09 |
| PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS)SYSTEM (P030017/S236) | Boston Scientific Corp | 2015-10-09 |
| PD-L1 IHC 28-8 pharmDx (P150025) | Agilent Technologies, Inc. | 2015-10-09 |
| STARCLOSE SE VASCULAR CLOSURE SYSTEM (P050007/S033) | Abbott Vascular Devices | 2015-10-09 |
| T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM (P140015/S001) | Tandem Diabetes Care, Inc. | 2015-10-08 |