| Impella CP/LD, Impella 2.5/5.0 (P140003/S033) | Abiomed, Inc. | 2018-07-10 |
| TMR Holmium Laser System (P970029/S037) | Cryolife, Inc. | 2018-07-10 |
| MULTI-LINK Vision/ MULTI-LINK Mini Vision Coronary Stent System, MULTI-LINK 8/ 8 SV/ 8 LL Coronary Stent System (P020047/S069) | Abbott Vascular | 2018-07-10 |
| Closer Vascular Sealing System (VSS) (P150022/S005) | Rex Medical, L.P. | 2018-07-10 |
| MynxGrip Vascular Closure Device (P040044/S081) | Cordis US Corporation | 2018-07-10 |
| GORE EXCLUDER AAA Endoprosthesis (P020004/S155) | W. L. Gore & Associates, Inc. | 2018-07-05 |
| INGEVITY MRI Passive Fixation Leads, INGEVITY non-MRI Passive Fixation Leads (P150012/S063) | Boston Scientific | 2018-07-05 |
| GORE TAG Thoracic Endoprosthesis (P040043/S102) | W. L. Gore & Associates, Inc. | 2018-07-05 |
| HeartMate 3 Left Ventricular Assist System (LVAS) (P160054/S007) | ABBOTT MEDICAL | 2018-07-05 |
| LifeVest Wearable Defibrillator (Model 4000) (P010030/S100) | Zoll Manufacturing Corporation | 2018-07-05 |
| GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P040037/S117) | W. L. Gore & Associates, Inc. | 2018-07-05 |
| GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P130006/S056) | W. L. Gore & Associates, Inc. | 2018-07-05 |
| GORE TIGRIS Vascular Stent (P160004/S014) | W. L. Gore & Associates, Inc. | 2018-07-05 |
| GORE VIABAHN VBX Balloon Expandable Endoprosthesis (P160021/S010) | W. L. Gore & Associates, Inc. | 2018-07-05 |
| GORE VIATORR TIPS Endoprosthesis (P040027/S064) | W. L. Gore & Associates, Inc. | 2018-07-05 |
| SynCardia temporary Total Artificial Heart (TAH-t) System- Companion 2 Driver System (P030011/S062) | Syncardia Systems, LLC | 2018-07-04 |
| AFX Endovascular AAA System (P040002/S060) | Endologix, LLC | 2018-07-03 |
| GORE VIATORR TIPS Endoprosthesis (P040027/S063) | W. L. Gore & Associates, Inc. | 2018-07-02 |
| GORE TAG Thoracic Endoprosthesis (P040043/S101) | W. L. Gore & Associates, Inc. | 2018-07-02 |
| ROTAPRO Rotational Atherectomy System (P900056/S171) | Boston Scientific Corp | 2018-07-02 |
| GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P040037/S116) | W. L. Gore & Associates, Inc. | 2018-07-02 |
| LIFEPAK 1000 DEFIBRILLATOR, LIFEPAK 20 DEFIBRILLATOR/ MONITOR, LIFEPAK 20E DEFIBRILLATOR/ MONITOR, LIFEPAK 15 MONITOR/DE (P160026) | Physio-Control, Inc. | 2018-07-02 |
| GORE TIGRIS Vascular Stent (P160004/S013) | W. L. Gore & Associates, Inc. | 2018-07-02 |
| GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P130006/S055) | W. L. Gore & Associates, Inc. | 2018-07-02 |
| GORE EXCLUDER AAA Endoprosthesis (P020004/S154) | W. L. Gore & Associates, Inc. | 2018-07-02 |
| CoreValve System, CoreValve Evolut R System, CoreValve Evolut PRO System (P130021/S050) | Medtronic, Inc. | 2018-07-02 |
| Hancock II Bioprosthesis (P980043/S067) | Medtronic, Inc. | 2018-06-29 |
| Hancock Valved Conduit (P870078/S042) | Medtronic, Inc. | 2018-06-29 |
| CVX-300-P Excimer Laser System (P910001/S097) | Spectranetics Corp. | 2018-06-29 |
| Hancock Modified Orifice Valved Conduit (P790007/S057) | Medtronic Heart Valves | 2018-06-29 |
| MitraClip Clip Delivery System (NTR and XTR) (P100009/S027) | ABBOTT MEDICAL | 2018-06-29 |
| Percepta Quad CRT-P MRI SureScan, Percepta CRT-P MRI SureScan, Serena Quad CRT-P MRI SureScan, Serena CRT-P MRI SureScan (P010015/S368) | Medtronic, Inc. | 2018-06-28 |
| Attain Bipolar OTW Lead and Attain OTW LV Lead (P010015/S374) | Medtronic, Inc. | 2018-06-28 |
| Revo MRI SureScan and CapSureFix MRI SureScan Lead (P090013/S281) | Medtronic, Inc. | 2018-06-28 |
| Attain Ability MRI SureScan Lead/Ability Plus MRI SureScan Lead and Attain Ability Straight MRI SureScan Lead and Attain (P080006/S121) | Medtronic, Inc. | 2018-06-28 |
| CapSureFix Novus MRi SureScan Lead and CapSureFix Novus MRI SureScan Lead (P930039/S186) | Medtronic, Inc. | 2018-06-28 |
| Lutonix Drug Coated Ballon (P130024/S023) | Lutonix | 2018-06-28 |
| Attain StarFix Lead (P060039/S088) | Medtronic, Inc. | 2018-06-28 |
| IS-1 Plug, Sprint Quattro Secure S MRI SureScan Lead, Sprint Quattro Secure MRI SureScan and Sprint Quattro MRI SureScan (P920015/S213) | Medtronic, Inc. | 2018-06-28 |
| Epic Vascular Self-Expanding Stent System (P110035/S046) | Boston Scientific Corp | 2018-06-28 |
| Lutonix Drug Coated Balloon (P170003/S003) | Lutonix | 2018-06-28 |
| Vitatron Crystalline Active Fixation Lead and Vitatron Pirouet Lead (P930039/S189) | Medtronic, Inc. | 2018-06-28 |
| CapSure Sense MRI SureScan Lead and CapSure Sense MRI SureScan Lead (P830061/S157) | Medtronic Cardiac Rhythm Disease Management | 2018-06-28 |
| SLS II/GlideLight catheters (P960042/S062) | Spectranetics (Philips) | 2018-06-28 |
| RF Contactr, RF Conductr and RF Marinr (P930029/S060) | Medtronic, Inc. | 2018-06-28 |
| Sprint Quattro Lead, Subcutaneous Lead and Transvene CS/SVC Lead (P920015/S215) | Medtronic, Inc. | 2018-06-28 |
| Attain Ability Lead and Attain Performa Lead (P080006/S123) | Medtronic, Inc. | 2018-06-28 |
| SelectSecure MRI SureScan Lead (P030036/S100) | Medtronic Cardiac Rhythm Disease Management | 2018-06-28 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S040) | Boston Scientific Corporation | 2018-06-28 |
| Vitatron Brilliant S+ VDD Lead (P890003/S392) | Medtronic, Inc. | 2018-06-28 |
| Vitatron Excellence SS+ Lead (P850089/S134) | Medtronic Cardiac Rhythm Disease Management | 2018-06-28 |
| Amplia MRI and Amplia MRI Quad CRT-D SureScan, Compia MRI and Compia MRI Quad CRT-D SureScan and Claria MRI and Claria M (P010031/S626) | Medtronic Cardiac Rhythm Disease Management | 2018-06-28 |
| Vitatron Crystalline Lead and Vitatron Excellence + Lead (P830061/S160) | Medtronic Cardiac Rhythm Disease Management | 2018-06-28 |
| Advisa MRI DR SureScan, Advisa MRI SR SureScan, Implantable Pulse Generators (IPGs), Attesta DR MRI SureScan (ATDR01), A (P980035/S549) | Medtronic, Inc. | 2018-06-28 |
| Transvene CS/SVC Lead (P980050/S118) | Medtronic, Inc. | 2018-06-28 |
| Innova Self-Expanding Stent System (P140028/S032) | Boston Scientific Corporation | 2018-06-28 |
| Evera MRIS XT DR/XT VR/S DR/S VR SureScan, Visia AF MRI XT and S VR SureScan, Primo MRI SureScan and Mirro MRI SureScan (P980016/S668) | Medtronic Cardiac Rhythm Disease Management | 2018-06-28 |
| SelectSecure Lead (P030036/S102) | Medtronic Cardiac Rhythm Disease Management | 2018-06-28 |
| Attain Ability Lead / Attain Performa Lead (P080006/S124) | Medtronic, Inc. | 2018-06-27 |
| HeartWare Ventricular Assist System (P100047/S123) | Medtronic | 2018-06-27 |
| Durata and Optisure Leads (P950022/S119) | ABBOTT MEDICAL | 2018-06-27 |
| Edwards Pericardial Aortic Bioprosthesis (P150048/S005) | Edwards Lifesciences, LLC | 2018-06-27 |
| Zilver Vascular Stent (P050017/S016) | Cook Ireland, Ltd. | 2018-06-26 |
| BioGlue Surgical Adhesive (P010003/S030) | Cryolife, Inc. | 2018-06-25 |
| HeartWare HVAD System (P100047/S110) | Medtronic | 2018-06-22 |
| Brava Quad CRT-D, Viva Quad S/XT CRT-D (P010031/S635) | Medtronic Cardiac Rhythm Disease Management | 2018-06-22 |
| PROMUS Element Plus/Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S157) | Boston Scientific Corp | 2018-06-21 |
| LifeStent 5mm Vascular Stent System (P070014/S056) | Bard Peripheral Vascular, Inc. | 2018-06-20 |
| Edwards Pericardial Aortic Bioprosthesis, Inspiris Resilia Aortic Model 11500A (P150048/S021) | Edwards Lifesciences, LLC | 2018-06-20 |
| Evia DR,DR-T,SR,SR-T; Entovis DR,DR-T,SR-T; Estella DR,DR-T,SR,SR-T; Effecta D,S; Edora 8 DR, 8 SR; Etrinsa 8 DR-T,SR-T, (P950037/S187) | Biotronik, Inc. | 2018-06-19 |
| Evia HF, HF-T, Entovis HF, HF-T, Edora 8 HF-T, Enitra HF-T, Etrinsa 8 HF-T, Epyra 8 HF-T, Eluna 8 HF-T, Edora 8 HF-T QP, (P070008/S091) | Biotronik, Inc. | 2018-06-19 |
| EMBLEM S-ICD Pulse Generator (PG), EMBLEM MRI S-ICD Pulse Generator (PG) (P110042/S110) | Boston Scientific Corporation | 2018-06-19 |
| lesto 7 DR-T, lperia 7 DR-T, lforia 7 DR-T, lnventra 7 DR-T, llesto 5 DR-T, ltrevia 5 DR-T, lforia 5 DR-T, lperia 5 DR-T (P050023/S117) | Biotronik, Inc. | 2018-06-19 |
| Allure, Allure Quadra, Quadra Allure MP, and Anthem (P030035/S170) | ABBOTT MEDICAL | 2018-06-15 |
| Relay Thoracic Stent-Graft with Plus Delivery System (P110038/S018) | Bolton Medical, Inc. | 2018-06-15 |
| Ellipse, Fortify, Fortify Assura and Quadra Assura MP (P910023/S409) | ABBOTT MEDICAL | 2018-06-15 |
| SmartAblate System (P990071/S039) | Biosense Webster, Inc. | 2018-06-15 |
| Quadra Assura, Unify, Unify Assura and Unify Quadra (P030054/S354) | ABBOTT MEDICAL | 2018-06-15 |
| 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/S633) | Medtronic Cardiac Rhythm Disease Management | 2018-06-15 |
| 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/S675) | Medtronic Cardiac Rhythm Disease Management | 2018-06-15 |
| LUTONIX® 035 Drug Coated Balloon PTA Catheter (P170003/S002) | Lutonix | 2018-06-15 |
| Assurity, Assurity +, Endurity, Accent and Victory XL (P880086/S300) | ABBOTT MEDICAL | 2018-06-15 |
| Assurity MRI and Endurity MRI (P140033/S032) | ABBOTT MEDICAL | 2018-06-15 |
| Astra XT DR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MIR IPG (P980035/S557) | Medtronic, Inc. | 2018-06-14 |
| GORE Viabahn Balloon Expandable VBX Endoprosthesis (P160021/S009) | W. L. Gore & Associates, Inc. | 2018-06-14 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S005) | Medinol, Ltd. | 2018-06-14 |
| GORE Viabahn Endoprosthesis with Heparin Bioactive Surface (P130006/S054) | W. L. Gore & Associates, Inc. | 2018-06-14 |
| NIRxcell CoCr Coronary Stent on RX System (P110004/S030) | Medinol, Ltd. | 2018-06-14 |
| GORE Viabahn Endoprosthesis with Heparin Bioactive Surface (P040037/S115) | W. L. Gore & Associates, Inc. | 2018-06-14 |
| GORE Tigris Vascular Stent (P160004/S012) | W. L. Gore & Associates, Inc. | 2018-06-14 |
| Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis / with ThermalFix tissue process/ RSR Pericardial Aortic B (P860057/S172) | Edwards Lifesciences, LLC | 2018-06-13 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D; Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D. Claria MI Quad CRT-D, Compia M (P010031/S632) | Medtronic Cardiac Rhythm Disease Management | 2018-06-13 |
| EDWARDS INTUITY Valve System (P150036/S022) | Edwards Lifesciences, LLC | 2018-06-13 |
| Tridyne Vascular Sealant (P150016/S014) | Neomend, Inc. | 2018-06-13 |
| 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/VR IC (P980016/S674) | Medtronic Cardiac Rhythm Disease Management | 2018-06-13 |
| FlexAbility Ablation Catheter, Sensor Enabled (FlexAbility SE) (P110016/S057) | ABBOTT MEDICAL | 2018-06-13 |
| Evia HF /HF-T; Entovis HF/ HF-T ; Edora 8 HF-T; Entira 8 HF-1; Etrinsa 8 HF-T; Epyra 8 HF-T; Eluna 8 HF-T; Edora 8HF-T Q (P070008/S093) | Biotronik, Inc. | 2018-06-13 |
| llesto 7 VT-T / 5 VR-T , 7 VR-T DX; Ifora 7 VR-T /5 VR-T /7 VR-T DX , 5 VR-T DX ; Itrevia 7 VT-T/ DX (GBLi), Intica 5 VR (P050023/S120) | Biotronik, Inc. | 2018-06-13 |
| Edwards Pericardial Aortic Bioprosthesis/ Edwards INSPIRIS RESILIA Aortic Valve (P150048/S011) | Edwards Lifesciences, LLC | 2018-06-13 |
| Evia DR /DR-T /SR/SR-T ;/Entovis DR /DR-T /SR /SR-T; Estella DR / DR-T/ SR /SR-T; Effecta D /S ;/ Endora 8 DR/ 8 SR; / (P950037/S191) | Biotronik, Inc. | 2018-06-13 |