| SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM(OVER-THE-WIRE& MONORAIL) (P150003/S003) | Boston Scientific Corporation | 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 |
| 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 |
| 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 |
| 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 |
| VENASEAL CLOSURE SYSTEM (P140018/S002) | Medtronic Vascular, 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 |
| 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 |
| BIOCOR VALVE, SUPRA VALVE; EPIC VALVE, SUPRA VALVE; TRIFECTA VALVE, TRIFECTA VALVE WITH GLIDE TECHONOLOGY (TRIFECTA GT) (P040021/S029) | ABBOTT MEDICAL | 2016-07-26 |
| 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 |
| 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 |
| Dynagen Models: G150, G151, G154, G156, G158; Inogen Models: G140, G141, G146, G148; Origen (P010012/S426) | Boston Scientific Corp | 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 |
| 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 |
| 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 |
| TENDRIL SDX, TENDRIL ST, TENDRIL STS, OPTISENSE (P960013/S082) | ABBOTT MEDICAL | 2016-07-19 |
| DURATA, OPTISURE (P950022/S093) | ABBOTT MEDICAL | 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 |
| 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 |
| PROMUS(ELEMENT PLUS/PREMIER) EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S122) | Boston Scientific Corp | 2016-07-15 |
| 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 |
| 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 |
| 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 |
| MEDTRONIC ATTAIN ABILITY MODEL 4196 LEAD (P080006/S095) | Medtronic, Inc. | 2016-07-13 |
| EXPRESS LD ILIAC OVER-THE-WIRE PREMOUNTED STENT SYSTEM (P090003/S041) | Boston Scientific Corporation | 2016-07-13 |
| 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 |
| ICD DEVICES: TELIGEN, ENERGEN, PUNCTUA, INCEPTA, OPRIGEN, INOGEN, DYNAGEN, AUTOGEN. (P960040/S370) | Boston Scientific | 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 |
| 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 |
| ARCTIC FRONT FAMILY CARDIAC CRYOABLATION CATHETERS (P100010/S057) | Medtronic Cryocath, LP | 2016-07-07 |
| PLATINIUM CRT-D (MODELS 1711 AND 1741) (P060027/S079) | MicroPort CRM USA, Inc. | 2016-07-07 |
| PLATINIUM VR (MODELS 1210 AND 1240) AND PLATINIUM DR (MODELS 1510 AND 1540) ICDS (P980049/S113) | MicroPort CRM USA, Inc. | 2016-07-07 |
| GORE EXCLUDER AAA ENDOPROSTHESIS & ILIAC BRANCH ENDOPROSTHESIS (P020004/S132) | W. L. Gore & Associates, Inc. | 2016-07-07 |
| FREEZOR FAMILY CARDIAC CRYOABLATION CATHETERS (P020045/S076) | Medtronic Cryocath, LP | 2016-07-07 |
| BIOGLUE SURGICAL ADHESIVE (P010003/S024) | Cryolife, Inc. | 2016-07-07 |
| BLAZER II, BLAZER II HTD TEMPERATURE ABLATION CATHETERS, BLAZER II XP, BLAZER PRIME XP TEMPERATURE ABLATION CATHETERS (P920047/S092) | Boston Scientific Corp | 2016-07-07 |
| ATTAIN STARFIX MODEL 4195 LEAD (P060039/S070) | Medtronic, Inc. | 2016-07-07 |
| INTELLATIP MIFI XP TEMPERATURE ABLATION SYSTEM (P020025/S088) | Boston Scientific | 2016-07-07 |
| INTELLANAV OPEN-IRRIGATED ABLATION CATHETER (P150005/S005) | Boston Scientific Corp | 2016-07-07 |
| SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM (P910001/S087) | Spectranetics Corp. | 2016-07-07 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S077) | Zoll Manufacturing Corporation | 2016-07-07 |
| ADVISA DR IPG, DR MRI IPG, SR MRI IPG (P980035/S466) | Medtronic, Inc. | 2016-07-06 |
| CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P (P010015/S301) | Medtronic, Inc. | 2016-07-06 |