| SAPIEN XT Transcatheter Heart Valve (Frame only) Ascendra+Delivery System/NovaFlex+Delivery System/Edwards Expandable In (P130009/S070) | Edwards Lifesciences, LLC | 2017-03-09 |
| Freestyle Bioprosthesis (P970031/S055) | Medtronic, Inc. | 2017-03-09 |
| SAPIEN 3 Transcatheter Heart Valve (Frame only) Commander Delivery System/Certitude Delivery System/ Certitude Introduce (P140031/S032) | Edwards Lifesciences, LLC | 2017-03-09 |
| Hancock Valved Conduit (P870078/S035) | Medtronic, Inc. | 2017-03-09 |
| Hancock Valved Conduit (P790007/S050) | Medtronic Heart Valves | 2017-03-09 |
| MISAGO PERIPHERAL SELF-EXPANDING STENT SYSTEM (P140002/S002) | Terumo Medical Corporation | 2017-03-08 |
| Evera MRI DF-1 ICD/ Evera MRI ICD/Evera S DR ICD/ Evera S VR ICD/ Evera XT DR ICD/Evera XT VR ICD/ Visia AF MRI DF1 ICD/ (P980016/S622) | Medtronic Cardiac Rhythm Disease Management | 2017-03-08 |
| Amplia MRI CRT-D/Amplia MRI Quad CRT-D/ Brava CRT-D/Claria Quad CRT-D/ Brava Quad CRT-D/ Compia MRI Quad CRT-D/ Viva Qua (P010031/S581) | Medtronic Cardiac Rhythm Disease Management | 2017-03-08 |
| Lutonix Drug Coated Balloon PTA Cateter (P130024/S018) | Lutonix | 2017-03-07 |
| FlexAbility Ablation Catheter and FlexAbility Ablation Catheter, Sensor Enabled (P110016/S038) | ABBOTT MEDICAL | 2017-03-07 |
| GORE EXCLUDER AAA ENDOPROSTHESIS, GORE EXCLUDER ILIAC BRANCH ENDOPROSTHESIS (P020004/S137) | W. L. Gore & Associates, Inc. | 2017-03-06 |
| Subcutaneous Implantable Defibrillator (S-ICD) System. (P110042/S078) | Boston Scientific Corporation | 2017-03-06 |
| Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer Software (P140033/S005) | ABBOTT MEDICAL | 2017-03-06 |
| Carbomedics Prosthetic Heart Valve (CPHV). (P900060/S056) | Corcym S.r.l. | 2017-03-03 |
| XIENCE V NANO, XIENCE PRIME XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM; HI-TORQUE PROGRESS, PILOT GUIDE (P110019/S085) | Abbott Vascular | 2017-03-03 |
| XIENCE V NANO, XIENCE PRIME XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM; HI-TORQUE PROGRESS, PILOT GUIDE (P070015/S133) | Abbott Vascular, Inc. | 2017-03-03 |
| INTELLATIP MIFI OPEN-IRRIGATED ABLATION CATHETER (P150005/S008) | Boston Scientific Corp | 2017-03-02 |
| THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (P060040/S064) | ABBOTT MEDICAL | 2017-03-02 |
| MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM (P150033/S016) | Medtronic, Inc. | 2017-03-02 |
| EDWARDS COMMANDER DELIVERY SYSTEM (P140031/S030) | Edwards Lifesciences, LLC | 2017-03-01 |
| SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM (P110042/S076) | Boston Scientific Corporation | 2017-03-01 |
| Advisa DR IPG A4DR01, Advisa DR MRI IPG A2DR01, Advisa SR MRI IPG A3SR01 (P980035/S488) | Medtronic, Inc. | 2017-02-28 |
| Amplia MRI/Amplia MRI Quad/Brava/Brava Quad/Claria MRI/Claria MRI Quad/Compia MRI/Concerto II/Consulta/Maximo II/Viva Qu (P010031/S580) | Medtronic Cardiac Rhythm Disease Management | 2017-02-28 |
| EDWARDS INTUITY ELITE VALVE SYSTEM (P150036/S005) | Edwards Lifesciences, LLC | 2017-02-28 |
| Evera MRI DF-1/Evera MRI/Evera S DR/Evera S VR/Evera XT DR/Evera XT VR/Maximo II/Secura DR/Serura/Virtuoso II DR/VR/Visi (P980016/S621) | Medtronic Cardiac Rhythm Disease Management | 2017-02-28 |
| Revo MRI SureScan IPG (P090013/S249) | Medtronic, Inc. | 2017-02-28 |
| Advisa DR/Advisa DR MRI/Advisa SR MRI IPG (P980035/S489) | Medtronic, Inc. | 2017-02-28 |
| QUALCRIMP CRIMPING ACCESSORY (LAMINATED) (P140031/S031) | Edwards Lifesciences, LLC | 2017-02-27 |
| MISAGO RX SELF-EXPANDING PERIPHERAL STENT SYSTEM (P140002/S007) | Terumo Medical Corporation | 2017-02-27 |
| PROMOTE+, UNIFY, UNIFY QUADRA/ASSURA AND QUADRA ASSURA FAMILY OF CRT-DS (P030054/S318) | ABBOTT MEDICAL | 2017-02-24 |
| PM1160, PM1240, PM1260, PM2160, PM2240, PM2260, PM1152, PM2152 (P880086/S278) | ABBOTT MEDICAL | 2017-02-24 |
| AFFINITY/ INTEGRITY/ VICTORY/ ZEPHYR/ ACCENT FAMILY OF PACEMAKERS (P880086/S277) | ABBOTT MEDICAL | 2017-02-24 |
| CD1231-40, CD1231-40Q, CD2231-40, CD2231-40Q, CD1257-40, CD1257-40Q, CD2257-40, CD2257-40Q, CD1357-40, CD1357-40C, CD135 (P910023/S380) | ABBOTT MEDICAL | 2017-02-24 |
| CD3231-40, CD3231-40Q, CD3257-40, CD3257-40Q, CD3357-40, CD3357-40C, CD3357-40Q, CD3357-40QC, (P030054/S319) | ABBOTT MEDICAL | 2017-02-24 |
| CURRENT+, FORTIFY, FORTIFY ASSURA AND ELLIPSE FAMILY OF ICDS (P910023/S379) | ABBOTT MEDICAL | 2017-02-24 |
| HOSPITAL WEARABLE DEFIBRILLATOR (HWD 1000) (P010030/S067) | Zoll Manufacturing Corporation | 2017-02-24 |
| DURATA AND OPTISURE LEADS (HV ACTIVE AND PASSIVE) (P950022/S100) | ABBOTT MEDICAL | 2017-02-24 |
| PM3120, PM3140, PM3222, PM3242, PM3160, PM3262 (P030035/S152) | ABBOTT MEDICAL | 2017-02-24 |
| MELODY TRANSCATHETER PULMONARY VALVE, ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM and ENSEMBLE II TRANSCATHETER VALVE D (P140017/S005) | Medtronic, Inc. | 2017-02-24 |
| MEDTRONIC VASCULAR ENDURANT STENT GRAFT SYSTEM (P100021/S058) | Medtronic Vascular | 2017-02-23 |
| ANGIOJET ULTRA XMI/SPIROFLEX/SPIROFLEX VG/DISTAFLEX THROMBECTOMY SET'S (P980037/S059) | Boston Scientific Corp | 2017-02-23 |
| PERCEVAL SUTURELESS HEART VALVE (P150011/S008) | Corcym S.r.l. | 2017-02-23 |
| DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (P130005/S015) | Cardiovascular Systems, Inc. | 2017-02-23 |
| REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM MONORAIL (P130030/S031) | Boston Scientific Corp | 2017-02-23 |
| AMPLATZER DUCT OCCLUDER/DUCT OCCLUDER II (P020024/S047) | ABBOTT MEDICAL | 2017-02-22 |
| DRIVER OVER-THE-WIRE, RAPID EXCHANGE, AND MULTI-EXCHANGE CORONARY STENT SYSTEMS (P030009/S091) | Medtronic, Ireland | 2017-02-22 |
| AMPLATZER MUSCULAR VSD OCCLUDER (P040040/S030) | ABBOTT MEDICAL | 2017-02-22 |
| AMPLATZER PFO OCCLUDER (P120021/S003) | ABBOTT MEDICAL | 2017-02-22 |
| THE AMPLATZER SEPTAL OCCLUDER/AMPLATZER CRIBRIFORM OCCLUDER (P000039/S057) | ABBOTT MEDICAL | 2017-02-22 |
| Tendril MRI (P140033/S001) | ABBOTT MEDICAL | 2017-02-21 |
| DURATA AND OPTISURE LEADS (HV ACTIVE AND PASSIVE) (P950022/S099) | ABBOTT MEDICAL | 2017-02-21 |
| XIENCE PRIME,XIENCE Xpedition,XIENCE Alpine,Everolimus Eluting Coronary Stent System, SV (2.25) LL (P110019/S087) | Abbott Vascular | 2017-02-21 |
| ISOFLEX OPTIM LEADS (LV PASSIVE) (P960030/S050) | ABBOTT MEDICAL | 2017-02-21 |
| MEDTRONIC ATTAIN ABILITY MODEL 4196 LEAD (P080006/S108) | Medtronic, Inc. | 2017-02-21 |
| TENDRIL SDX/ST/STS AND OPTISENSE LEADS (LV ACTIVE) (P960013/S088) | ABBOTT MEDICAL | 2017-02-21 |
| XIENCE V Everolimus Eluting Coronary Stent System; XIENCE nano EECSS (P070015/S134) | Abbott Vascular, Inc. | 2017-02-21 |
| QUICKFLEX U AND QUARTET LEADS (CRT) (P030054/S317) | ABBOTT MEDICAL | 2017-02-21 |
| TRYTON SIDE BRANCH STENT (P150039) | Poseidon Medical, Inc. | 2017-02-21 |
| COBRA PzF NanoCoated Coronary Stent System (P160014) | Celonova Biosciences, Inc. | 2017-02-21 |
| VISIONIST Cardiac Resynchronization Therapy Pacemaker (CRT-P) Devices (P030005/S150) | Guidant Corp. | 2017-02-21 |
| Evera MRI DF-1ICD DDMB1D1, DDMC3D1 L; Evera MRI ICD DDMB1D4, DDMC3D4, DVMB1D4, DVMC3D4; Evera S DR ICD DDBC3D1, DDBC3D4; (P980016/S619) | Medtronic Cardiac Rhythm Disease Management | 2017-02-21 |
| Amplia MRI CRTD DTMB1D4, DTMB1D1; Amplia MRI Quad CRT-D DTMB1QQ, DTMB1Q1; Brava CRT-D DTBC1D4, DTBC1D1, Brava Quad CRTD (P010031/S578) | Medtronic Cardiac Rhythm Disease Management | 2017-02-21 |
| Adapta, Versa, Sensia, Advisa, Advisa MRI, EnPulse, Kappa (P980035/S485) | Medtronic, Inc. | 2017-02-17 |
| Revo MRI (P090013/S243) | Medtronic, Inc. | 2017-02-17 |
| Viva, Brava, Protecta, Protecta XT, Concerto, Concerto II, Consulta, Maximo II, (P010031/S573) | Medtronic Cardiac Rhythm Disease Management | 2017-02-17 |
| FLEXABILITY ABLATION CATHETER, SENSOR ENABLED (P110016/S025) | ABBOTT MEDICAL | 2017-02-17 |
| Evera MRI, Evera, Marquis, Secura, Maximo II, Intrinsic, Protecta, Protecta XT, (P980016/S613) | Medtronic Cardiac Rhythm Disease Management | 2017-02-17 |
| Consulta CRT-P, Syncra CRT-P, Viva CRT-P (P010015/S315) | Medtronic, Inc. | 2017-02-17 |
| MEDTRONIC MYCARELINK PATIENT MONITOR MODEL (P890003/S369) | Medtronic, Inc. | 2017-02-17 |
| MICRA (P150033/S013) | Medtronic, Inc. | 2017-02-17 |
| SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM EMBLEM (P110042/S070) | Boston Scientific Corporation | 2017-02-16 |
| PERCEVAL SUTURELESS HEART VALVE (P150011/S007) | Corcym S.r.l. | 2017-02-16 |
| TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN (P960040/S386) | Boston Scientific | 2017-02-16 |
| CAPSUREFIX NOVUS LEAD ; VITATRON CRYSTALLLINE ACTIVE FIXATION LEAD (P930039/S167) | Medtronic, Inc. | 2017-02-16 |
| EDWARDS INTUITY ELITE VALVE SYSTEM (AORTIC VALVE MODEL 8300AB) (P150036/S004) | Edwards Lifesciences, LLC | 2017-02-16 |
| CRT D RESYNCHRONIZATION DEVICES, COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN (P010012/S439) | Boston Scientific Corp | 2017-02-16 |
| ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT, INSIGNIA, ALTRUA 2 (N970003/S200) | Boston Scientific Corp | 2017-02-16 |
| LATITUDE NXT Patient Management System, LATITUDE Wave Communicator (P910077/S157) | Boston Scientific | 2017-02-16 |
| CRT-P RESYNCHRONIZATION DEVICES, INVIVE, INTUA, VISIONIST, VALITUDE (P030005/S148) | Guidant Corp. | 2017-02-16 |
| CAPSUREFIX MRI LEAD (P090013/S247) | Medtronic, Inc. | 2017-02-16 |
| VASCADE VASCULAR CLOSURE SYSTEM (P120016/S022) | Cardiva Medical, Inc. | 2017-02-15 |
| PROSTAR 9 FR. PERCUTANEOUS VASCULAR SURGICAL (PVS) SYSTEM (P960043/S096) | Abbott Vascular, Inc. | 2017-02-15 |
| ATTAIN BIPOLAR OTW LEAD, ATTAIN OTW LV LEAD (P010015/S320) | Medtronic, Inc. | 2017-02-14 |
| PRO-KINETIC ENERGY COBALT CHROMIUM (CoCr) CORONARY STENT SYSTEM (P160003) | Biotronik AG | 2017-02-14 |
| Visia AF Software SW035 Version 8.1 (P890003/S371) | Medtronic, Inc. | 2017-02-14 |
| CAPSURE SP, CAPSURE, CAPSURE 2 LEADS, EXCELLENCE S, IMPULSE, IMPLUSE II EXCELLENCE SS, LEADS (P850089/S123) | Medtronic Cardiac Rhythm Disease Management | 2017-02-14 |
| EMBLEM SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) (P110042/S075) | Boston Scientific Corporation | 2017-02-14 |
| EPICARDIAL PATCH LEAD (P900061/S145) | Medtronic Cardiac Rhythm Disease Management | 2017-02-14 |
| MEDTRONIC(R) CAPSURE(R) EPI PACING LEAD MODEL 4695 (P950024/S072) | Medtronic, Inc. | 2017-02-14 |
| DYNAGEN, INOGEN, ORIGEN, AUTOGEN CARDIAC RESYNCHRONIZATION THERAPYN DEFIBRILLATOR (CRT_D) (P010012/S444) | Boston Scientific Corp | 2017-02-14 |
| CARDIOMEMS HF SYSTEM (P100045/S018) | ABBOTT MEDICAL | 2017-02-14 |
| CARDIOMEMS HF SYSTEM (P100045/S014) | ABBOTT MEDICAL | 2017-02-14 |
| DYNAGEN, INOGEN, ORIGEN, AUTOGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) (P960040/S388) | Boston Scientific | 2017-02-14 |
| IS-1 CONNECTOR PORT PIN PLUG KIT, SPRINT QUATTRO LEAD, SUBCUTANEOUS LEAD, TRANSVENE CS/SVC LEAD (P920015/S195) | Medtronic, Inc. | 2017-02-14 |
| ATTAIN STARFIX MODEL 4195 LEAD (P060039/S077) | Medtronic, Inc. | 2017-02-14 |
| CAPSURE SENSE LEAD, CAPSURE SP NOVUS LEAD, VITATRON CRYSTALLINE LEAD, VITATRON EXCELLENCE PS+ LEAD (P830061/S142) | Medtronic Cardiac Rhythm Disease Management | 2017-02-14 |
| MEDTRONIC ATTAIN ABILITY MODEL 4196 LEAD (P080006/S106) | Medtronic, Inc. | 2017-02-14 |
| Visia AF software SW035 Version 8.1 (P980016/S615) | Medtronic Cardiac Rhythm Disease Management | 2017-02-14 |
| TRANSVENE CS/SVC LEAD (P980050/S109) | Medtronic, Inc. | 2017-02-14 |
| INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM (P140028/S024) | Boston Scientific Corporation | 2017-02-13 |