| Amplia MRI CRT-D, Amplia MRI quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia (P010031/S629) | Medtronic Cardiac Rhythm Disease Management | 2018-05-16 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S370) | Medtronic, Inc. | 2018-05-16 |
| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra XT DR MRI IPG, Astra S DR MRI IPG, (P980035/S551) | Medtronic, Inc. | 2018-05-16 |
| Pro-Kinetic Energy Coronary Stent System (P160003/S004) | Biotronik AG | 2018-05-16 |
| Ingevity Lead Family (P150012/S059) | Boston Scientific | 2018-05-16 |
| Revo MRI SureScan IPG (P090013/S283) | Medtronic, Inc. | 2018-05-16 |
| TatiCath Quartz Set (P130026/S032) | St Jude Medical | 2018-05-16 |
| Acuity Spiral Lead Family, Acuity X4 Lead Family (P010012/S483) | Boston Scientific Corp | 2018-05-16 |
| Astron Peripheral Self-Expanding Nitinol Stent System (P140030/S006) | Biotronik AG | 2018-05-16 |
| Astron Pulsar/Pulsar-18 Stent System (P140030/S007) | Biotronik AG | 2018-05-15 |
| EMBLEM MRI S-CD/ EMBLEM S-CD Pulse Generator (PG) (P110042/S107) | Boston Scientific Corporation | 2018-05-15 |
| Paradym CRT-D, Paradym RF CRT-D (ZL 102), Intensia CRT-D, Platinium CRT-D, Platinium 4LV CRT-D (P060027/S096) | MicroPort CRM USA, Inc. | 2018-05-14 |
| Reply SR, Reply DR, Esprit SR, Esprit DR (P950029/S122) | MicroPort CRM USA, Inc. | 2018-05-14 |
| Paradym VR, Paradym DR, Paradym RF VR, Paradym RF DR (ZL 102) Intensia VR ICD, Intensia DR, Platinium VR, Platinium DR (P980049/S131) | MicroPort CRM USA, Inc. | 2018-05-14 |
| Advisa DR IPG, Advisa DDR MRI IPG and Advisa SR MRI IPG (P980035/S547) | Medtronic, Inc. | 2018-05-08 |
| Revo MRI SureScan IPG (P090013/S279) | Medtronic, Inc. | 2018-05-08 |
| Spectranetics Laser Sheaths SLS (SLS ll/GlideLight) (P960042/S060) | Spectranetics (Philips) | 2018-05-08 |
| Consulta, Syncra and Viva CRT-P (P010015/S367) | Medtronic, Inc. | 2018-05-08 |
| S-ICD Battery Anode Laser Edge Weld Process (P110042/S109) | Boston Scientific Corporation | 2018-05-08 |
| CVX-300 Excimer Laser System/ELCA Coronary Atherectomy Catheter (P910001/S104) | Spectranetics Corp. | 2018-05-08 |
| Ovation iX Abdominal Stent Graft System (P120006/S030) | Endologix, LLC | 2018-05-08 |
| Edwards Intuity Elite Valve System, Aortic Valve Model 8300AB and Delivery System Model 8300DB (P150036/S029) | Edwards Lifesciences, LLC | 2018-05-07 |
| Edwards Pericardial Aortic Bioprosthesis, Edwards Inspiris Resilia Aortic Valve (P150048/S020) | Edwards Lifesciences, LLC | 2018-05-07 |
| Edwards Sapien XT Transcatheter Heart Valve (P130009/S089) | Edwards Lifesciences, LLC | 2018-05-07 |
| Edwards Sapien 3 Transcatheter Heart Valve (P140031/S065) | Edwards Lifesciences, LLC | 2018-05-07 |
| Carpentier-Edwards Perimount Pericardial Bioprosthesis (P860057/S178) | Edwards Lifesciences, LLC | 2018-05-07 |
| Reliance 4- Front Lead Family and Suture Sleeve Accessory (P910073/S145) | Boston Scientific | 2018-05-04 |
| Tridyne Vascular Sealant (P150016/S013) | Neomend, Inc. | 2018-05-04 |
| Evera MRI DF-1 ICD, Evera MRI ICD< Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, M (P980016/S669) | Medtronic Cardiac Rhythm Disease Management | 2018-05-04 |
| Gen V CryoConsole RoHS Compliant (P100010/S076) | Medtronic Cryocath, LP | 2018-05-04 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia (P010031/S627) | Medtronic Cardiac Rhythm Disease Management | 2018-05-04 |
| Gen V CryoConsole (P020045/S087) | Medtronic Cryocath, LP | 2018-05-04 |
| Arctic Front Advance Pro Cardiac Cryoablation Catheter (P100010/S070) | Medtronic Cryocath, LP | 2018-05-04 |
| Talent Occluder (P100021/S071) | Medtronic Vascular | 2018-05-03 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia (P010031/S625) | Medtronic Cardiac Rhythm Disease Management | 2018-05-03 |
| Allure, Allure Quadra, Quadra Allure MP (P030035/S169) | ABBOTT MEDICAL | 2018-05-03 |
| Advisa DR IPG, Advisa DR/SR MRI IPG, Astra XT DR MRI IPG, Astra S DR/SR/XT MRI IPG, Azure S DR/SR MRI IPG, Azure XT DR/S (P980035/S548) | Medtronic, Inc. | 2018-05-03 |
| Endurant, Endurant II, Endurant IIs (P100021/S070) | Medtronic Vascular | 2018-05-03 |
| Evera NRI DF-1 ICD, Evera MRI ICD, Evera S DR/VR ICD, Evera XT DR/VR ICD, Mirro MRI DR/VR ICD, Primo MRI DR/VR ICD, Prot (P980016/S667) | Medtronic Cardiac Rhythm Disease Management | 2018-05-03 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S366) | Medtronic, Inc. | 2018-05-03 |
| Assurity, Assurity +, Endurity (P880086/S298) | ABBOTT MEDICAL | 2018-05-03 |
| Endurity MRI, Assurity MRI (P140033/S029) | ABBOTT MEDICAL | 2018-05-03 |
| Revo MRI SureScan IPG (P090013/S280) | Medtronic, Inc. | 2018-05-03 |
| Micra TPS (P150033/S035) | Medtronic, Inc. | 2018-05-03 |
| Valiant Captivia (P100040/S035) | Medtronic Vascular | 2018-05-03 |
| Amplia MR CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT_D, Claria MRI Quad CRT-D, Compia M (P010031/S623) | Medtronic Cardiac Rhythm Disease Management | 2018-05-03 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, Mirro MRI VR ICD, (P980016/S665) | Medtronic Cardiac Rhythm Disease Management | 2018-05-03 |
| Heart Light Catheter with Excalibur Balloon (P150026/S002) | Cardiofocus, Inc. | 2018-05-02 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S365) | Medtronic, Inc. | 2018-05-02 |
| Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra XT DR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra (P980035/S546) | Medtronic, Inc. | 2018-05-02 |
| Impella CP with SmartAssist (P140003/S030) | Abiomed, Inc. | 2018-05-02 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia (P010031/S624) | Medtronic Cardiac Rhythm Disease Management | 2018-05-02 |
| Micra TPS (P150033/S034) | Medtronic, Inc. | 2018-05-02 |
| SynCardia temporary Total Artificial Heart (TAH-t) (P030011/S051) | Syncardia Systems, LLC | 2018-05-02 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, Mirro MRI VR ICD, (P980016/S666) | Medtronic Cardiac Rhythm Disease Management | 2018-05-02 |
| Revo MRI SureScan IPG (P090013/S278) | Medtronic, Inc. | 2018-05-02 |
| Misago RX Self-expanding Peripheral Stent (P140002/S012) | Terumo Medical Corporation | 2018-04-30 |
| Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Relia IPG, Sphera DR MRI IPG, Sphera SR MRI IPG (P980035/S545) | Medtronic, Inc. | 2018-04-30 |
| Impella 2.5 System, Impella CP System, Impella CP Optical System, Impella 5.0 System, and Impella LD System (P140003/S029) | Abiomed, Inc. | 2018-04-30 |
| Impella RP System (P170011/S005) | Abiomed, Inc. | 2018-04-30 |
| MynxGrip, Mynx Ace Vascular Closure Device (VCD) (P040044/S080) | Cordis US Corporation | 2018-04-27 |
| Angio-Seal Vascular Closure Devices (P930038/S088) | Terumo Medical Corporation | 2018-04-26 |
| THE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEM (P000039/S060) | ABBOTT MEDICAL | 2018-04-26 |
| Ventak AV Acid Ventak Prizm DR/VR, Vitality, Cofient, and Teligen Automatic Implantable Cardioverter Defibrillator Syste (P960040/S423) | Boston Scientific | 2018-04-25 |
| Contak Renewal Models H125 and H120 with the Model 2865 Version 1.8 Application Software (P030005/S175) | Guidant Corp. | 2018-04-25 |
| PRO-Kinetic Energy Coronary Stent System (P160003/S002) | Biotronik AG | 2018-04-25 |
| Subcutaneous Implantable Defibrillator (S-ICD) System (P110042/S106) | Boston Scientific Corporation | 2018-04-25 |
| Assurity MRI, Endurity MRI (P140033/S028) | ABBOTT MEDICAL | 2018-04-25 |
| Contak CD,Easytrak, Livian, Cognis and Acuity Spirial Automatic Implantable Cardiac Resynchronization Therapy Defibrill (P010012/S482) | Boston Scientific Corp | 2018-04-25 |
| Allure RF, Allure Quadra RF, Allure Quadra, Allure, Quadra Allure MP,Quadra Allure MP RF (P030035/S168) | ABBOTT MEDICAL | 2018-04-25 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, M (P980016/S664) | Medtronic Cardiac Rhythm Disease Management | 2018-04-25 |
| Astron Pulsar/Pulsar-18 Stent System (P160025/S001) | Biotronik AG | 2018-04-25 |
| Artic Front Advance Cardiac CryoAblation Catheter (P100010/S078) | Medtronic Cryocath, LP | 2018-04-25 |
| Assurity, Assurity +, Endurity, Endurity Core (P880086/S297) | ABBOTT MEDICAL | 2018-04-25 |
| Acuity Steerable Lead System (P050046/S028) | Guidant Corp. | 2018-04-25 |
| SynCardia temporary Toatl Artificial Heart (TAH-t) System - Companion 2 Driver System (P030011/S061) | Syncardia Systems, LLC | 2018-04-25 |
| Imageready MR Conditional Pacing System and Ingevity Pace/Sense Lead (P150012/S058) | Boston Scientific | 2018-04-25 |
| Ellipse VR, Ellipse DR, Fortify, Fortify Assura (P910023/S408) | ABBOTT MEDICAL | 2018-04-25 |
| Ventak(R) PRX (TM) Model 1700,1705 Pulse Generator (P910077/S166) | Boston Scientific | 2018-04-25 |
| Unify, Unify Quadra, Unify Assura, Quadra Assura, Quadra Assura MP (P030054/S353) | ABBOTT MEDICAL | 2018-04-25 |
| Ventak and Automatic Implantable Cardioverter Defibrillator (AICD) Systems (P830060/S082) | Boston Scientific | 2018-04-25 |
| Thinline Endocardial Pacing Leads (P960004/S083) | Boston Scientific | 2018-04-25 |
| Ventak(R) P2 System (P930035/S029) | Boston Scientific | 2018-04-25 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia (P010031/S622) | Medtronic Cardiac Rhythm Disease Management | 2018-04-25 |
| Reply SR, Reply DR, Esprit SR, Esprit DR (P950029/S121) | MicroPort CRM USA, Inc. | 2018-04-25 |
| Astron Peripheral Self-Expanding Nitinol Stent System (P140030/S004) | Biotronik AG | 2018-04-25 |
| Endotak Lead System (P910073/S148) | Boston Scientific | 2018-04-25 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S363) | Medtronic, Inc. | 2018-04-25 |
| Pulsar/Pulsar Max Implantable Pulse Generator System with Consult Software (N970003/S228) | Boston Scientific Corp | 2018-04-25 |
| Paradym RF CRT-d 9750, Platinium CRT-D 1711, Platinium CRT-D 1741, Platinium 4 LV CRT-D 1744 (P060027/S095) | MicroPort CRM USA, Inc. | 2018-04-25 |
| Sweet Tip(R) RX Steroid Eluting Lead (P960006/S047) | Boston Scientific | 2018-04-25 |
| Revo MRI SureScan IPG (P090013/S275) | Medtronic, Inc. | 2018-04-25 |
| Paradym RF VR 9250, Paradym RF DR 9550, Platinium VR 1210, Platinium VR 1240, Platinium DR 1510, Platinium DR 1540 (P980049/S130) | MicroPort CRM USA, Inc. | 2018-04-25 |
| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra XT DR MRI IPG, Astra S DR MRI IPG, (P980035/S544) | Medtronic, Inc. | 2018-04-25 |
| Prostar XL Percutaneous Vascular Surgical System and Perclose ProGlide Suture-Mediated Closure System (P960043/S100) | Abbott Vascular, Inc. | 2018-04-24 |
| Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Intrinsic 30 ICD, Marquis VR ICD, Maxim (P980016/S658) | Medtronic Cardiac Rhythm Disease Management | 2018-04-24 |
| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, EnPulse Ei IPG, EnPulse E2 IPG, Kappa D (P980035/S534) | Medtronic, Inc. | 2018-04-24 |
| Revo MRI SureScan IPG (P090013/S270) | Medtronic, Inc. | 2018-04-24 |
| MyCareLink Monitor (P890003/S385) | Medtronic, Inc. | 2018-04-24 |
| StarClose SE Vascular Closure System (P050007/S036) | Abbott Vascular Devices | 2018-04-24 |