| Diamondback 360 Coronary Orbital Atherectomy System (P130005/S024) | Cardiovascular Systems, Inc. | 2018-06-12 |
| Trifecta Valve, Trifecta Valve with Glide Technology (Trifecta GT ) (P100029/S034) | ABBOTT MEDICAL | 2018-06-12 |
| St.Jude Medical Biocor, Epic and Epic Supra Valves (P040021/S036) | ABBOTT MEDICAL | 2018-06-12 |
| Siello S 45, Siello S 53, Siello S 60, Solia S 45, Solia S 53, Solia S 60 (P950037/S189) | Biotronik, Inc. | 2018-06-12 |
| CapSure Epicardial Pacing Lead (P950024/S079) | Medtronic, Inc. | 2018-06-11 |
| Attain Bipolar OTW Lead, Attain OTW LV Lead, Consulta CRT-P, Percepta Bipolar/Quadripolar CRT-P, Serena Bipolar/ Quadrip (P010015/S373) | Medtronic, Inc. | 2018-06-11 |
| CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead (P930039/S188) | Medtronic, Inc. | 2018-06-11 |
| Y Adaptor/Extender Kit, DF-1/IS-1 Connector Port Pin Plug, HV Splitter/Adaptor Kit, Lead Adaptor, Sprint Quatro Lead, Su (P920015/S214) | Medtronic, Inc. | 2018-06-11 |
| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR/SR MRI IPG, Astra XT/ S DR MRI IPG, Astra S/XT SR MRI IPG, Attesta D (P980035/S556) | Medtronic, Inc. | 2018-06-11 |
| CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead (P850089/S133) | Medtronic Cardiac Rhythm Disease Management | 2018-06-11 |
| Evera MRI 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/S673) | Medtronic Cardiac Rhythm Disease Management | 2018-06-11 |
| Myocardial Pacing Lead (P120017/S013) | Medtronic, Inc. | 2018-06-11 |
| Attain StarFix Lead (P060039/S087) | Medtronic, Inc. | 2018-06-11 |
| Transvene CS/SVC Lead (P980050/S117) | Medtronic, Inc. | 2018-06-11 |
| CapSureFix MRI Lead, Revo MRI SureScan IPG (P090013/S286) | Medtronic, Inc. | 2018-06-11 |
| Attain Ability Lead, Attain Performa Lead (P080006/S122) | Medtronic, Inc. | 2018-06-11 |
| Adhesive, CapSure Sense Lead, CapSure SP Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead (P830061/S159) | Medtronic Cardiac Rhythm Disease Management | 2018-06-11 |
| ACE Header, Defibrillation Support Device (DISD), End Cap, Epicardial Patch Lead, Upsizing Sleeve (P900061/S149) | Medtronic Cardiac Rhythm Disease Management | 2018-06-11 |
| CapSure VDD 2 Lead, Vitatron Brilliant S+ VDD Lead (P890003/S391) | Medtronic, Inc. | 2018-06-11 |
| Anchoring Sleeve Kit, SelectSecure Lead (P030036/S101) | Medtronic Cardiac Rhythm Disease Management | 2018-06-11 |
| 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/S631) | Medtronic Cardiac Rhythm Disease Management | 2018-06-11 |
| Revo MRI SureScan IPG (P090013/S285) | Medtronic, Inc. | 2018-06-08 |
| Consulta CRT-P, Percepta Bipolar/Quadripolar CRT-P, Serena Bipolar/Quadripolar CRT-P, Solara Bipolar/Quadripolar CRT-P, (P010015/S372) | Medtronic, Inc. | 2018-06-08 |
| Advisa DR IPG, Advisa DR/SR MRI IPG (P980035/S555) | Medtronic, Inc. | 2018-06-08 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S004) | Medinol, Ltd. | 2018-06-07 |
| NIRxcell CoCr Coronary Stent on RX System (P110004/S027) | Medinol, Ltd. | 2018-06-07 |
| Impella 5.0 System (P140003/S036) | Abiomed, Inc. | 2018-06-07 |
| Percepta Bipolar/Quadripolar CRT-P, Serena Bipolar/Quadripolar CRT-P, Solara Bipolar/Quadripolar CRT-P (P010015/S371) | Medtronic, Inc. | 2018-06-05 |
| Astra XT/S DR MRI IPG, Astra S/XT SR MRI IPG, Azure S/XT DR MRI IPG, Azure S/XT SR MRI IPG (P980035/S553) | Medtronic, Inc. | 2018-06-05 |
| Evera MRI DF-1, Evera MRI ICD's; Mirro MIR DR, Mirro MIR VR ICD's; Primo MRI DR, Primo MRI VR ICD's; Visia AF MRI DF1, V (P980016/S663) | Medtronic Cardiac Rhythm Disease Management | 2018-06-05 |
| Gore Viabahn VBX Balloon Expandable Endoprosthesis (P160021/S008) | W. L. Gore & Associates, Inc. | 2018-06-01 |
| Gore Viabahn Endoprosthesis, Gore Viabahn Endoprosthesis with Heaparin Bioactive Surface (P130006/S053) | W. L. Gore & Associates, Inc. | 2018-06-01 |
| Gore Tigris Vascular Stent (P160004/S011) | W. L. Gore & Associates, Inc. | 2018-06-01 |
| 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/S634) | Medtronic Cardiac Rhythm Disease Management | 2018-06-01 |
| Visitag Surpoint External Processing Unit (EPU) (P030031/S086) | Biosense Webster, Inc. | 2018-06-01 |
| Implantable Cardioverter Defibrillator (ICD), Dynagen EL/Mini ICD, Inogen EL/Mini ICD, Origen EL ICD/Mini ICD, Autogen E (P960040/S425) | Boston Scientific | 2018-06-01 |
| HeartMate 3 Left Ventricular Assist System (LVAS) (P160054/S009) | ABBOTT MEDICAL | 2018-06-01 |
| S-ICD Pulse Generator, Emblem S-ICD, Emblem MRI S-ICD (P110042/S108) | Boston Scientific Corporation | 2018-06-01 |
| Gore Viabahn Endoprosthesis, Gore Viabahn Endoprosthesis with Heaparin Bioactive Surface (P040037/S114) | W. L. Gore & Associates, Inc. | 2018-06-01 |
| Cardiac Resynchronization Therapy Defibrillator (CRT-D), Dynagen CRT-D/X4 CRT-D, Inogen CRT-D/X4 CRT-D, Origen CRT-D/X4 (P010012/S485) | Boston Scientific Corp | 2018-06-01 |
| HeartMate ll Left Ventricular Assist System (LVAS) (P060040/S070) | ABBOTT MEDICAL | 2018-06-01 |
| 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 DF2 IC (P980016/S676) | Medtronic Cardiac Rhythm Disease Management | 2018-06-01 |
| SAPIEN XT Transcatheter Heart Valve (P130009/S090) | Edwards Lifesciences, LLC | 2018-05-31 |
| CapSureFix MRI Lead (P090013/S284) | Medtronic, Inc. | 2018-05-31 |
| SLS II/Glide Light Catheters (P960042/S061) | Spectranetics (Philips) | 2018-05-31 |
| CapSure Sense Lead (P830061/S158) | Medtronic Cardiac Rhythm Disease Management | 2018-05-31 |
| GORE Cardioform Septal Occluder (P050006/S068) | W. L. Gore & Associates, Inc. | 2018-05-31 |
| SAPIEN 3 Transcatheter Heart Valve (P140031/S066) | Edwards Lifesciences, LLC | 2018-05-31 |
| Edwards INSPIRIS RESILIA Aortic Valve and Edwards Pericardial Aortic Bioprosthesis (P150048/S022) | Edwards Lifesciences, LLC | 2018-05-31 |
| Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis; Theon Pericardial Aortic BIoprosthesis with ThermaFix tis (P860057/S179) | Edwards Lifesciences, LLC | 2018-05-31 |
| Adapta, Versa, Sensia IPG, Advisa SR MRI IPG, Attesta DR/SR MRI IPG, Sphera DR/SR MRI IPG (P980035/S554) | Medtronic, Inc. | 2018-05-31 |
| HeartMate 3 Left Ventricular Assist System (P160054/S006) | ABBOTT MEDICAL | 2018-05-31 |
| CapSureFix Novus Lead (P930039/S187) | Medtronic, Inc. | 2018-05-31 |
| EDWARDS INTUITY ELITE Valve System (P150036/S030) | Edwards Lifesciences, LLC | 2018-05-31 |
| XIENCE Xpedition Everolimus Eluting Coronary Stent System, SV (2.25), LL; XIENCE Alpine Everolimus Eluting Coronary Sten (P110019/S098) | Abbott Vascular | 2018-05-30 |
| Consulta CRT-P, Syncra CRT-P and Viva CRT-P (P010015/S369) | Medtronic, Inc. | 2018-05-30 |
| Viva, Brava, Protecta, Protecta XT, Concerto, Concerto II, Consulta, Maximo II, InSync II Protect, Amplia, Compia and Cl (P010031/S628) | Medtronic Cardiac Rhythm Disease Management | 2018-05-30 |
| MyCareLink Monitor 4G Cellular Modem (P890003/S390) | Medtronic, Inc. | 2018-05-30 |
| Absorb GT1 Bioresorbable Vascular Scaffold (BVS) System (P150023/S010) | Abbott Vascular, Inc. | 2018-05-30 |
| Adapta, Versa, Sensia, Advisa, Advisa MRI, EnPulse and Kappa (P980035/S550) | Medtronic, Inc. | 2018-05-30 |
| Micra (P150033/S036) | Medtronic, Inc. | 2018-05-30 |
| Revo MRI (P090013/S282) | Medtronic, Inc. | 2018-05-30 |
| Evera MRI, Evera, Marquis, Secura, Maximo II, Intrinsic, Protecta, Protecta XT, Virtuoso II and Visia AF (P980016/S670) | Medtronic Cardiac Rhythm Disease Management | 2018-05-30 |
| Everolimus Eluting Coronary Stent System (P070015/S141) | Abbott Vascular, Inc. | 2018-05-30 |
| Tendril MRI (P140033/S030) | ABBOTT MEDICAL | 2018-05-29 |
| OneStep Pacing Cable Assembly used wit R Series Device (P160022/S002) | ZOLL Medical Corporation | 2018-05-29 |
| Impella 2.5 and Impella CP Ventricular Support Systems (P140003/S035) | Abiomed, Inc. | 2018-05-25 |
| IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PT A) Balloon Catheter (P140010/S039) | Medtronic, Inc. | 2018-05-25 |
| Gore Tigris Vascular Stent (P160004/S009) | W. L. Gore & Associates, Inc. | 2018-05-24 |
| Carbomedics Prosthetic Heart Valve (P900060/S057) | Corcym S.r.l. | 2018-05-24 |
| Gore Tag Thoracic Endoprosthesis (P040043/S099) | W. L. Gore & Associates, Inc. | 2018-05-24 |
| HeartWare Ventricular Assist System (P100047/S121) | Medtronic | 2018-05-24 |
| Impella 2.5, Impella CP Ventricular Support Systems (P140003/S034) | Abiomed, Inc. | 2018-05-24 |
| Gore Viatorr Tips Endoprosthesis; Gore Viatorr Tips Endoprosthesis with Controlled Expansion (P040027/S061) | W. L. Gore & Associates, Inc. | 2018-05-24 |
| Gore Viabahn VBX Balloon Expandable Endoprosthesis (P160021/S006) | W. L. Gore & Associates, Inc. | 2018-05-24 |
| Misago RX Self-Expanding Peripheral Stent (P140002/S016) | Terumo Medical Corporation | 2018-05-24 |
| Gore Viabahn Endoprosthesis, Gore Viabahn Endoprosthesis with Heparin Bioactive Surface (P130006/S051) | W. L. Gore & Associates, Inc. | 2018-05-24 |
| Gore Helex Septal Occluder, Gore CardioForm Septal Occluder (P050006/S065) | W. L. Gore & Associates, Inc. | 2018-05-24 |
| Gore Viabahn Endoprosthesis, Gore Viabahn Endoprosthesis with Heparin Bioactive Surface (P040037/S112) | W. L. Gore & Associates, Inc. | 2018-05-24 |
| Gore Excluder AAA Endoprosthesis and Gore Excluder Iliac Branch Endoprsthesis (P020004/S152) | W. L. Gore & Associates, Inc. | 2018-05-24 |
| MitraClip System (NTR and XTR) (P100009/S025) | ABBOTT MEDICAL | 2018-05-23 |
| XIENCE Sierra Everolimus Eluting Coronary Stent System (P110019/S094) | Abbott Vascular | 2018-05-22 |
| Rebel Platinum Chromium Coronary Stent System (P130030/S051) | Boston Scientific Corp | 2018-05-22 |
| Promus Premier Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S156) | Boston Scientific Corp | 2018-05-22 |
| Rebel Platinum Chromium Coronary Stent System (Monorail) (P130030/S049) | Boston Scientific Corp | 2018-05-21 |
| EXCOR Pediatric Ventricular Assist Device (P160035/S001) | Berlin Heart, Inc. | 2018-05-21 |
| 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/S672) | Medtronic Cardiac Rhythm Disease Management | 2018-05-21 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solar Bipolar CRT-P, (P010015/S357) | Medtronic, Inc. | 2018-05-21 |
| 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/S630) | Medtronic Cardiac Rhythm Disease Management | 2018-05-21 |
| Gore Viatorr Tips Endoprosthesis (P040027/S060) | W. L. Gore & Associates, Inc. | 2018-05-18 |
| MFC-CPRD Cable Assembly used with X Series and R Series Device (P160022/S003) | ZOLL Medical Corporation | 2018-05-18 |
| Adapta, Versa, Sensia IPG, Attesta IPG, Relia IPG, Sphera IPG (P980035/S552) | Medtronic, Inc. | 2018-05-18 |
| LifeVest Wearable Defibrillator (P010030/S105) | Zoll Manufacturing Corporation | 2018-05-18 |
| Impella 2.5 and Impella CP Ventricular Support System (P140003/S032) | Abiomed, Inc. | 2018-05-18 |
| Watchman Left Atrial Appendage Closure Technology (P130013/S019) | Boston Scientific Corp | 2018-05-18 |
| HeartMate 3 Left Ventricular Assist System (P160054/S010) | ABBOTT MEDICAL | 2018-05-18 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XR DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, M (P980016/S671) | Medtronic Cardiac Rhythm Disease Management | 2018-05-16 |
| Fineline ll Lead Family (P960004/S084) | Boston Scientific | 2018-05-16 |
| Astron Pulsar/Pulsar-18 Stent Systems (P160025/S004) | Biotronik AG | 2018-05-16 |
| Endotak Reliance IS-1 Lead Family, Endotak Reliance IS4 Lead Family, Reliance 4-Front Lead Family (P910073/S149) | Boston Scientific | 2018-05-16 |