| RESOLUTE INTEGRITY ZOTAROLIMUS ELUTING CORONARY STENT SYSTEM (P110013/S072) | Medtronic Vascular | 2016-07-06 |
| MYNX ACE VASCULAR CLOSURE DEVICE (P040044/S073) | Cordis US Corporation | 2016-07-06 |
| REVO MRI SURESCAN IPG (P090013/S227) | Medtronic, Inc. | 2016-07-06 |
| IN.PACT ADMIRAL PACLITAXEL-COATED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER (P140010/S013) | Medtronic, Inc. | 2016-07-06 |
| ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM (P150023) | Abbott Vascular, Inc. | 2016-07-05 |
| BLAZER OPEN-IRRIGATED ABLATION CATHETER (P150005/S001) | Boston Scientific Corp | 2016-07-05 |
| ENROUTE TRANSCAROTID STENT SYSTEM (P140026/S003) | Boston Scientific Corporation | 2016-07-05 |
| SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-t) SYSTEM (P030011/S044) | Syncardia Systems, LLC | 2016-07-05 |
| MITRACLIP AND MITRACLIP NT CLIP DELIVERY SYSTEM (P100009/S020) | ABBOTT MEDICAL | 2016-07-05 |
| BLAZER OPEN-IRRIGATED ABLATION CATHETER (P150005/S006) | Boston Scientific Corp | 2016-07-05 |
| Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Aortic Bioprosthesis with ThermaFix tissue process (P860057/S150) | Edwards Lifesciences, LLC | 2016-07-05 |
| Adapta, Versa, Sensia IPG ADDR01, ADDR03, ADDR06, ADDRL1, ADDRS1, SEDR01, SESR01, VEDR01, ADD01, SEDRL1, SED01, SES01, A (P980035/S465) | Medtronic, Inc. | 2016-07-05 |
| ZILVER VASCULAR STENT (P050017/S013) | Cook Ireland, Ltd. | 2016-07-01 |
| Carpentier-Edwards PERIMOUNT (P860057/S151) | Edwards Lifesciences, LLC | 2016-07-01 |
| Prostar XL 10F Percutaneous Vascular Surgical System (P960043/S093) | Abbott Vascular, Inc. | 2016-07-01 |
| ZILVER PTX DRUG-ELUTING PERIPHERAL STENT (P100022/S018) | Cook Ireland, Ltd. | 2016-07-01 |
| CORDIS EXOSEAL VASCULAR CLOSURE DEVICE (P100013/S013) | Cordis US Corporation | 2016-06-30 |
| LIVEWIRE TC ABLATION CATHETER AND SAFIRE BI-DIRECTIONAL ABLATION CATHETER (P960016/S066) | St Jude Medical | 2016-06-29 |
| MICRONY PACEMAKERS (P970013/S069) | ABBOTT MEDICAL | 2016-06-28 |
| ACCENT, IDENTITY, VERITY, VICTORY AND ZEPHYR PACEMAKERS (P880086/S272) | ABBOTT MEDICAL | 2016-06-28 |
| Quadra Assura/Unify Assura Family of CRt-Ds (P030054/S302) | ABBOTT MEDICAL | 2016-06-28 |
| Ellipse/Fortify Assura Family of ICDs (P910023/S371) | ABBOTT MEDICAL | 2016-06-28 |
| WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE (LAAC) DEVICE (P130013/S010) | Boston Scientific Corp | 2016-06-28 |
| LUTONIX DRUG COATED BALLOON PTA CATHETER (P130024/S011) | Lutonix | 2016-06-28 |
| ANTHEM AND FRONTIER II CRT-P'S (P030035/S146) | ABBOTT MEDICAL | 2016-06-28 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES (P130009/S060) | Edwards Lifesciences, LLC | 2016-06-27 |
| COOL PATH DUO ABLATION CATHETER MEDIGUIDE ENABLED, AND SAFIRE DUO ABLATION CATHETER MEDIGUIDE ENABLED, THERAPY COOL PATH (P110016/S033) | ABBOTT MEDICAL | 2016-06-24 |
| NIRXCELL COCR CORONARY STENT ON RX SYSTEM (NIRXCELL STENT SYSTEM) (P110004/S017) | Medinol, Ltd. | 2016-06-24 |
| ENDURANT, ENDURANT II, ENDURANT II AORTO-UNI-ILIAC (AUI), ENDURANT IIS STENT GRAFT SYSTEM (P100021/S053) | Medtronic Vascular | 2016-06-24 |
| Various models of Evia, Entovis, Estella, Effecta, Ecuro, Eluna, Etrinsa, Epyra Pulse Generator Families (P950037/S163) | Biotronik, Inc. | 2016-06-24 |
| Stratos LV/LV-T, Evia/Entovis HF/HF-T, Eluna/Erinsa/Epyra 8 HF-T CRT-Ps (P070008/S073) | Biotronik, Inc. | 2016-06-24 |
| REPLY DR, REPLY SR, ESPRIT DR, ESPRIT SR (P950029/S105) | MicroPort CRM USA, Inc. | 2016-06-24 |
| THERAPY ABLATION CATHETER (INCLUDING BI-DIRECTIONAL) THERAPY 4MM THERMISTOR ABLATION CATHETER (P040014/S030) | Irvine Biomedical, Inc. | 2016-06-24 |
| Various models of single chamber ICDS in the Lumax, Ilesto, Iforia, Iperia, Itrevia, Inventra Families, Various models o (P050023/S099) | Biotronik, Inc. | 2016-06-24 |
| HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S076) | Medtronic | 2016-06-24 |
| ORCHESTRA AND ORCHESTRA PLUS PROGRAMMER (P980049/S109) | MicroPort CRM USA, Inc. | 2016-06-24 |
| IN.PACT ADMIRAL PACLITAXEL-COATED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER (P140010/S019) | Medtronic, Inc. | 2016-06-24 |
| MITRACLIP NT CLIP DELIVERY SYSTEM (P100009/S019) | ABBOTT MEDICAL | 2016-06-24 |
| THERAPY COOL PATH ABLATION CATHETER, THERAPY COOL PATH SP ABLATION CATHETER, SAFIRE BLU ABLATION CATHETER (P060019/S037) | Irvine Biomedical, Inc. | 2016-06-24 |
| MEDTRONIC ATTAIN ABILITY MODEL 4196 LEAD (P080006/S094) | Medtronic, Inc. | 2016-06-24 |
| THERAPY DUAL 8 THERAPY 8MM THERMISTER ABLATION CATHETER, SAFIRE TX BI-DIRECTIONAL ABLATION CATHETER (P040042/S035) | Irvine Biomedical,Inc.(Ibi) | 2016-06-24 |
| RES-Q and RES-Q MICRON ICD and ICD Lead Family (P940008/S032) | Boston Scientific | 2016-06-23 |
| SWEET TIP RX, SWEET PICOTIP Rx, and FLEXTEND Pacing Lead Families (P960006/S046) | Boston Scientific | 2016-06-23 |
| Blazer II, Blazer II HTD, Blazer Prime HTD (P920047/S091) | Boston Scientific Corp | 2016-06-23 |
| Contak CD, Contak Renewal, Livian ICD Families; EasyTrak, Acuity Spiral Lead Families; Cognis, Energen, Incepta, Origen, (P010012/S422) | Boston Scientific Corp | 2016-06-23 |
| THINLINE/FINELINE Family of ENDOCARDIAL PACING LEADS (P960004/S076) | Boston Scientific | 2016-06-23 |
| IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD (P150012/S008) | Boston Scientific | 2016-06-23 |
| VENTAK(R) P2 ICD FAMILY (P930035/S028) | Boston Scientific | 2016-06-23 |
| SELUTE Pacing Lead Family (P950001/S028) | Boston Scientific | 2016-06-23 |
| Blazer II XP, Blazer Prime XP, IntellaTip MiFi XP, IntellaNav XP, IntellaNav MiFi XP (P020025/S087) | Boston Scientific | 2016-06-23 |
| ENDOTAK LEAD SYSTEM (P910073/S135) | Boston Scientific | 2016-06-23 |
| VENTAK ICD Family (P830060/S081) | Boston Scientific | 2016-06-23 |
| CHILLI COOLED RF ABLATION SYSTEM (P980003/S066) | Boston Scientific Corp | 2016-06-23 |
| BLAZER OPEN-IRRIGATED ABLATION CATHETER (P150005/S007) | Boston Scientific Corp | 2016-06-23 |
| VENTAK PRX and VENTAK MINI ICD Families (P910077/S153) | Boston Scientific | 2016-06-23 |
| HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM (P100047/S075) | Medtronic | 2016-06-23 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC AND MITRAL BIOPROSTHESIS (P860057/S149) | Edwards Lifesciences, LLC | 2016-06-23 |
| TMR HOLMIUM LASER SYSTEM (P970029/S030) | Cryolife, Inc. | 2016-06-23 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S071) | Medtronic Vascular | 2016-06-22 |
| EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (EVERFLEX) (P110023/S019) | Medtronic Vascular, Inc. | 2016-06-22 |
| REPLY SR, REPLY DR, ESPRIT SR, ESPRIT DR Pacemakers (P950029/S110) | MicroPort CRM USA, Inc. | 2016-06-22 |
| MEDTRONIC COREVALVE(R) EVOLUT R SYSTEM (P130021/S021) | Medtronic, Inc. | 2016-06-21 |
| TMR HOLMIUM LASER SYSTEM (P970029/S029) | Cryolife, Inc. | 2016-06-21 |
| ESSENTIO VALITUDE MRI: L110, L111, L131;PROPONENT VALITUDE MRI: L210, L211, L231; ACCOLADE VALITUDE MRI: L310, L311, (P150012/S007) | Boston Scientific | 2016-06-20 |
| ORIGEN EL ICD: D050, D051, D052, D053; INOGEN EL ICD: D140, D141, D142, D143; DYNAGEN EL ICD: D150, D151, D152, D1 (P960040/S373) | Boston Scientific | 2016-06-20 |
| Ingenio 2 Pacemakers; ALTRUA 2 Models: S701, S702, S722; ESSENTIO Models: L100, L101, L121; PROPONENT Models: L200, (N970003/S190) | Boston Scientific Corp | 2016-06-20 |
| DYNAGEN CRT-D: G150, G151, G154 DYNAGEN X4 CRT-D: G156, G158; INOGEN CRT-D: G140, G141 INOGEN X4 CRT-D: G146, G1 (P010012/S421) | Boston Scientific Corp | 2016-06-20 |
| Ingenio 2 CRT-P Devices; VALITUDE Model: U125; VALITUDE X4 Model: U128 (P030005/S137) | Guidant Corp. | 2016-06-20 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S076) | Zoll Manufacturing Corporation | 2016-06-17 |
| SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (Monorail) (P150003/S013) | Boston Scientific Corporation | 2016-06-17 |
| THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (P060040/S052) | ABBOTT MEDICAL | 2016-06-17 |
| Sprint Quattro Lead (P920015/S180) | Medtronic, Inc. | 2016-06-17 |
| SPECTRANETICS LASER SHEATHS (P960042/S054) | Spectranetics (Philips) | 2016-06-16 |
| MyCareLink Patient Monitor 24950 (P890003/S355) | Medtronic, Inc. | 2016-06-16 |
| SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P150003/S014) | Boston Scientific Corporation | 2016-06-16 |
| MEDTRONIC VASCULAR ENDURANT STENT GRAFT SYSTEM (P100021/S052) | Medtronic Vascular | 2016-06-16 |
| AMPLIA MRI, AMPLIA MRI QUAD, BRAVA, BRAVA QUAD, COMPIA MRI,COMPIA MRI QUAD, VIVA QUAD S, VIVA QUAD XT, VIVA S, VIVA XT C (P010031/S547) | Medtronic Cardiac Rhythm Disease Management | 2016-06-16 |
| EVERA MRI, EVERA S DR, EVERA S VR, EVERA XT DR, EVERA XT VR, VISIA AF MRI VR, VISIA AF VR ICD. (P980016/S587) | Medtronic Cardiac Rhythm Disease Management | 2016-06-16 |
| EXCIMER LASER CORONARY ATHERECTOMY CATHETER (P910001/S086) | Spectranetics Corp. | 2016-06-16 |
| PROMRI ICD SYSTEM (P050023/S095) | Biotronik, Inc. | 2016-06-16 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM AND PROMUS PREMIER EVEROLIMUS-ELUTING PLA (P110010/S126) | Boston Scientific Corp | 2016-06-16 |
| Integrity Coronary Stent Systems (P030009/S087) | Medtronic, Ireland | 2016-06-15 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S070) | Medtronic Vascular | 2016-06-15 |
| INGEVITY LEADS (P150012/S005) | Boston Scientific | 2016-06-15 |
| THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM (P870072/S062) | Thoratec Laboratories Corp. | 2016-06-14 |
| Concerto II CRT-D D274TRK, Consulta CRT-D D204TRM, Consulta CRT-D D224TRK, Maximo II CRT-D D264TRM, D284TRK, Protecta CR (P010031/S552) | Medtronic Cardiac Rhythm Disease Management | 2016-06-14 |
| WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST (P010030/S073) | Zoll Manufacturing Corporation | 2016-06-14 |
| Maximo II ICD D264DRM, D264VRM, D284VRC, D284DRG; Protecta ICD D334DRG, D334VRG, D334DRM, D334VRM; Protecta XT ICD D314D (P980016/S591) | Medtronic Cardiac Rhythm Disease Management | 2016-06-14 |
| FLEXABILITY ABLATION CATHETER (BI-DIRECTIONAL), (UNI-DIRECTIONAL) (P110016/S032) | ABBOTT MEDICAL | 2016-06-14 |
| EXCLUDER BIFURCATED ENDOPROSTHESIS (P020004/S126) | W. L. Gore & Associates, Inc. | 2016-06-13 |
| RESOLUTE MICROTRAC/RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S069) | Medtronic Vascular | 2016-06-10 |
| EDWARD SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES (P140031/S017) | Edwards Lifesciences, LLC | 2016-06-10 |
| CLOSER VASCULAR SEALING SYSTEM (P150022/S001) | Rex Medical, L.P. | 2016-06-10 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES (P130009/S059) | Edwards Lifesciences, LLC | 2016-06-10 |
| S.M.A.R.T. CONTROL NITINOL STENT SYSTEM (P020036/S037) | Cordis US Corporation | 2016-06-09 |
| ACUITY X4 (Straight,Spiral S, Spiral L) Steroid-eluting, Coronary Venous, QUADRIPOLAR ACE/SENSE LEADS (P010012/S416) | Boston Scientific Corp | 2016-06-09 |
| FLEXTOME CUTTING BALLOON MICROSURGICAL DILITATION DEVICE (P950020/S073) | Boston Scientific Corp | 2016-06-09 |
| CARDIOMESSENGER SMART (P050023/S098) | Biotronik, Inc. | 2016-06-08 |
| EXCLUDER BIFURCATED AAA ENDOPROSTHESIS (P020004/S131) | W. L. Gore & Associates, Inc. | 2016-06-08 |
| SIELLO S 45, SIELLO S 53,SIELLO S 60,SOLIA S45,SOLIA S 53,SOLIA S60 (P950037/S156) | Biotronik, Inc. | 2016-06-08 |