| Amplatzer Patent FOramen Ovale Occluder (P120021/S011) | ABBOTT MEDICAL | 2019-03-25 |
| Amplatzer Duct Occluder, Amplatzer Duct Occluder II and Amplatzer Piccolo Occluder (P020024/S056) | ABBOTT MEDICAL | 2019-03-25 |
| Biocor and Epic Valves (P040021/S040) | ABBOTT MEDICAL | 2019-03-25 |
| Amplatzer Muscular VSD Occluder (P040040/S036) | ABBOTT MEDICAL | 2019-03-25 |
| St. Jude Medical Masters Mechanical Heart Valve, Regent Mechanical Heart Valve, Masters Valves Graft (P810002/S109) | ABBOTT MEDICAL | 2019-03-25 |
| Trifecta and Trifecta GT surgical Heart Valve (P100029/S039) | ABBOTT MEDICAL | 2019-03-25 |
| Amplatzer Septal Occluder and Amplatzer Cribriform Occluder (P000039/S065) | ABBOTT MEDICAL | 2019-03-25 |
| GORE CARDIOFORM Septal Occuluder (P050006/S073) | W. L. Gore & Associates, Inc. | 2019-03-25 |
| LIFEPAK 15 monitor/defibrillator (P160026/S004) | Physio-Control, Inc. | 2019-03-24 |
| GORE VIABAHN Endoprosthesis (P040037/S123) | W. L. Gore & Associates, Inc. | 2019-03-22 |
| GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P130006/S062) | W. L. Gore & Associates, Inc. | 2019-03-22 |
| Consulta CRT-P; Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P; Serena Bipolar CRT-P, Serena Quadripolar CRT-P; Sola (P010015/S395) | Medtronic, Inc. | 2019-03-21 |
| GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P130006/S067) | W. L. Gore & Associates, Inc. | 2019-03-21 |
| X Series/Propaq MD (P160022/S009) | ZOLL Medical Corporation | 2019-03-21 |
| Adapta, Versa, Sensia IPG; Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG; Astra S DR MRI IPG, Astra S SR MRI IPG, (P980035/S579) | Medtronic, Inc. | 2019-03-21 |
| Amplia MRI CRT-D, Amplia Quad CRT-D; Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia MRI (P010031/S660) | Medtronic Cardiac Rhythm Disease Management | 2019-03-21 |
| GORE VIATORR TIPS Endoprosthesis and GORE VIATORR TIPS Endoprosthesis with Controlled Expansion (P040027/S070) | W. L. Gore & Associates, Inc. | 2019-03-21 |
| Angio-Seal Vascular Closure Devices (P930038/S092) | Terumo Medical Corporation | 2019-03-21 |
| EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System (P110023/S025) | Medtronic Vascular, Inc. | 2019-03-21 |
| 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/S700) | Medtronic Cardiac Rhythm Disease Management | 2019-03-21 |
| OPTIMIZER Smart System (P180036) | Impulse Dynamics (Usa), Inc. | 2019-03-21 |
| COBRA PzF NanoCoated Coronary Stent System (P160014/S008) | Celonova Biosciences, Inc. | 2019-03-21 |
| GORE VIABAHN Endoprosthesis (P040037/S128) | W. L. Gore & Associates, Inc. | 2019-03-21 |
| Zilver Vascular Stent (P050017/S017) | Cook Ireland, Ltd. | 2019-03-21 |
| Perceval Sutureless Heart Valve and Perceval Plus Sutureless Heart Valve (P150011/S016) | Corcym S.r.l. | 2019-03-20 |
| Solo Smart Heart Valve (P130011/S007) | Corcym Canada Corp | 2019-03-20 |
| Impella 2.5 (P140003/S048) | Abiomed, Inc. | 2019-03-20 |
| CVX-300 Excimer Laser System and ELCA Coronary Atherectomy Catheters (P910001/S109) | Spectranetics Corp. | 2019-03-20 |
| CardioMEMS HF System (P100045/S038) | ABBOTT MEDICAL | 2019-03-20 |
| Edwards SAPIEN 3 (XT) Transcatheter Heart Valves (P130009/S097) | Edwards Lifesciences, LLC | 2019-03-19 |
| PLATINIUM VR 1210; PLATINIUM VR 1240; PLATINIUM DR 1510; PLATINIUM DR 1540; PLATINIUM CRT-D 1711; PLATINIUM CRT-D 1741; (P980049/S133) | MicroPort CRM USA, Inc. | 2019-03-19 |
| Wolverine Coronary Cutting Balloon (P950020/S096) | Boston Scientific Corp | 2019-03-19 |
| Edwards SAPIEN 3, SAPIEN 3 Ultra Transcatheter Heart Valves (P140031/S082) | Edwards Lifesciences, LLC | 2019-03-19 |
| PLATINIUM VR 1210; PLATINIUM VR 1240; PLATINIUM DR 1510; PLATINIUM DR 1540; PLATINIUM CRT-D 1711; PLATINIUM CRT-D 1741; (P060027/S098) | MicroPort CRM USA, Inc. | 2019-03-19 |
| Edwards SAPIEN 3 Transcatheter Heart Valves (P140031/S083) | Edwards Lifesciences, LLC | 2019-03-19 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S005) | Boston Scientific Corp | 2019-03-18 |
| GORE TAG Thoracic Endoprosthesis (P040043/S109) | W. L. Gore & Associates, Inc. | 2019-03-18 |
| GORE TIGRIS Vascular Stent (P160004/S026) | W. L. Gore & Associates, Inc. | 2019-03-18 |
| GORE CARDIOFORM Septal Occluder (P050006/S074) | W. L. Gore & Associates, Inc. | 2019-03-18 |
| GORE Carotid Stent (P180010/S004) | W. L. Gore & Associates, Inc. | 2019-03-18 |
| GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P040037/S129) | W. L. Gore & Associates, Inc. | 2019-03-18 |
| GORE VIABAHN VBX Balloon Expandable Endoprosthesis (P160021/S019) | W. L. Gore & Associates, Inc. | 2019-03-18 |
| GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P130006/S068) | W. L. Gore & Associates, Inc. | 2019-03-18 |
| GORE VIABAHN VBX Balloon Expandable Endoprosthesis Manufacturing Expansion (P160021/S018) | W. L. Gore & Associates, Inc. | 2019-03-18 |
| GORE VIATORR TIPS Endoprosthesis (P040027/S071) | W. L. Gore & Associates, Inc. | 2019-03-18 |
| GORE EXCLUDER AAA Endoprosthesis (P020004/S163) | W. L. Gore & Associates, Inc. | 2019-03-18 |
| COBRA PzF NanoCoated Coronary Stent System (P160014/S006) | Celonova Biosciences, Inc. | 2019-03-15 |
| TactiCath Quartz Contract Force Ablation Catheter (P130026/S040) | St Jude Medical | 2019-03-14 |
| MynxGrip, Mynx Ace and Mynx Control Vascular Closure Device (VCD) (P040044/S083) | Cordis US Corporation | 2019-03-14 |
| Supera Peripheral Stent System (P120020/S022) | Abbott Vascular (Idef Technologies Inc) | 2019-03-14 |
| INGEVITY Distal Tip Laser Weld Process (P150012/S072) | Boston Scientific | 2019-03-14 |
| MitraClip NT Clip Delivery System and MitraClip NTR/XTR Clip Delivery System (P100009/S028) | ABBOTT MEDICAL | 2019-03-14 |
| XACT Carotid Stent System (P040038/S035) | Abbott Vascular, Inc. | 2019-03-14 |
| Resolute Onyx RX Zotarolimus Eluting Coronary Stent System / Resolute Onyx OTW Zotarolimus Eluting Coronary Stent System (P160043/S018) | Medtronic Vascular | 2019-03-14 |
| Implantable Cardioverter Defibrillator (P960040/S435) | Boston Scientific | 2019-03-13 |
| Edwards SAPIEN 3 Transcatheter Heart Valve and Accessories (P140031/S084) | Edwards Lifesciences, LLC | 2019-03-13 |
| PSW 1803.U /HMSC 3.40.2 / CardioMessenger Smart (P070008/S098) | Biotronik, Inc. | 2019-03-13 |
| Cardiac Resynchronization Therapy Defibrillator (P010012/S499) | Boston Scientific Corp | 2019-03-13 |
| LifeVest Wearable Defibrillator (P010030/S114) | Zoll Manufacturing Corporation | 2019-03-13 |
| PSW 1803.U / HMSC 3.40.2 / CardioMessenger Smart (P950037/S197) | Biotronik, Inc. | 2019-03-13 |
| HeartWare Ventricular Assist System (HVAD) (P100047/S135) | Medtronic | 2019-03-13 |
| Assurity, Assurity+, Endurity, Accent family of Pacemakers (P880086/S304) | ABBOTT MEDICAL | 2019-03-13 |
| Venovo Venous Stent System (P180037) | Bard Peripheral Vascular, Inc. | 2019-03-13 |
| PSW 1803.U / HMSC 3.40.2 /CardioMessenger Smart (P000009/S078) | Biotronik, Inc. | 2019-03-13 |
| Acticor 7 VR-T / Rivacor 7 VR-T /5VR-T /3 VR-T / Acticor 7 VR-T DX / Rivacor 7 VR-T DX /Rivacor 5 VR-T DX ; Acticor 7 DR (P050023/S125) | Biotronik, Inc. | 2019-03-13 |
| Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs (P910023/S414) | ABBOTT MEDICAL | 2019-03-13 |
| Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programmer Software (P140033/S041) | ABBOTT MEDICAL | 2019-03-13 |
| Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+ (P030054/S364) | ABBOTT MEDICAL | 2019-03-13 |
| Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps (P030035/S175) | ABBOTT MEDICAL | 2019-03-13 |
| CardioMEMS HF System (P100045/S035) | ABBOTT MEDICAL | 2019-03-13 |
| WATCHMAN Left Atrial Appendage Closure Device and Delivery System (P130013/S027) | Boston Scientific Corp | 2019-03-12 |
| Sprint Quattro Lead (P920015/S227) | Medtronic, Inc. | 2019-03-08 |
| Resolute Integrity Zotarolimus-Eluting Coronary Stent System (P110013/S094) | Medtronic Vascular | 2019-03-08 |
| Celsius RMT Catheter; Navistar RMT Thermocool Catheter; Celsius RMT Thermocool Catheter; Navistar RMT Catheter (P950005/S071) | Biosense Webster, Inc. | 2019-03-08 |
| Navistar RMT Catheter (P990025/S057) | Biosense Webster, Inc. | 2019-03-08 |
| Navistar RMT Thermocool Catheter; Celsius Thermocool Catheter; Celsius RMT Thermocool Catheter (P030031/S096) | Biosense Webster, Inc. | 2019-03-08 |
| Navistar RMT Thermocool Catheter (P040036/S066) | Biosense Webster, Inc. | 2019-03-08 |
| Endurant Stent Graft System, Endurant II Stent Graft System, Endurant II Aorto-Uni-Iliac (AUI) Stent Graft System, Endur (P100021/S072) | Medtronic Vascular | 2019-03-08 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System (P160043/S021) | Medtronic Vascular | 2019-03-08 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System (P160043/S022) | Medtronic Vascular | 2019-03-07 |
| CardioMEMS HF System (P100045/S037) | ABBOTT MEDICAL | 2019-03-07 |
| GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P130006/S066) | W. L. Gore & Associates, Inc. | 2019-03-06 |
| Micra TPS (P150033/S049) | Medtronic, Inc. | 2019-03-06 |
| GORE Carotid Stent (P180010/S003) | W. L. Gore & Associates, Inc. | 2019-03-06 |
| GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P040037/S127) | W. L. Gore & Associates, Inc. | 2019-03-06 |
| Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG; Azure S DR MRI IPG, Azure S SR MRI IP (P980035/S578) | Medtronic, Inc. | 2019-03-06 |
| GORE TIGRIS Vascular Stent (P160004/S025) | W. L. Gore & Associates, Inc. | 2019-03-06 |
| Percepta Bipolar CRT-P; Percepta Quadripolar CRT-P; Serena Bipolar CRT-P; Serena Quadripolar CRT-P; Solara Bipolar CRT-P (P010015/S393) | Medtronic, Inc. | 2019-03-06 |
| Angio-Seal Vascular Closure Devices (P930038/S091) | Terumo Medical Corporation | 2019-03-06 |
| GORE VIABAHN VBX Balloon Expandable Endoprosthesis (P160021/S017) | W. L. Gore & Associates, Inc. | 2019-03-06 |
| Sprint Quattro Secure and Sprint Quattro Secure S (P920015/S225) | Medtronic, Inc. | 2019-03-05 |
| Implantable Cardioverter Defibrillator ICDs (P980049/S134) | MicroPort CRM USA, Inc. | 2019-03-05 |
| AMPLATZER Duct Occluder, Occluder II; AMPLATZER Piccolo Occluder (P020024/S055) | ABBOTT MEDICAL | 2019-03-05 |
| AMPLATZER PFO Occluder (P120021/S010) | ABBOTT MEDICAL | 2019-03-05 |
| TactiCatch Quartz Contact Force Ablation Catheter (P130026/S042) | St Jude Medical | 2019-03-05 |
| AMPLATZER Muscular VSD Occluder (P040040/S035) | ABBOTT MEDICAL | 2019-03-05 |
| Livewire TC Cables; Safire Ablation Catheter; Safire Cable (P960016/S077) | St Jude Medical | 2019-03-05 |
| FlexAbility and FlexAbility SE Ablation Catheter; FlexAbility Cables, Sensor Enabled (P110016/S059) | ABBOTT MEDICAL | 2019-03-05 |
| Secura DR ICD, Maximo II DR ICD, Protecta XT DR ICD, Protecta DR ICD, Secura VR ICD, Maximo II VR ICD, Protecta XT VR IC (P980016/S698) | Medtronic Cardiac Rhythm Disease Management | 2019-03-05 |
| AMPLATZER Septal Occluder, AMPLATZER Multi-Fenestrated Septal Occluder (P000039/S064) | ABBOTT MEDICAL | 2019-03-05 |