| Fortify Models CD1231-40, CD1231-40Q, CD2231-40, CD2231-40Q; Fortify Assura Models CD1257-40, CD1257-40Q, CD2257-40, CD2 (P910023/S406) | ABBOTT MEDICAL | 2018-04-04 |
| Epic Vascular Self-Expanding Stent System (P110035/S045) | Boston Scientific Corp | 2018-04-03 |
| Protecta ICD, Protecta VR ICD, ProtectaXT ICD, Secura DR ICD, Secura ICD (P980016/S660) | Medtronic Cardiac Rhythm Disease Management | 2018-04-03 |
| Angio Seal Vascular Closure Devices (P930038/S087) | Terumo Medical Corporation | 2018-04-03 |
| Consulta CRT-P, Syncra CRT-P, Viva CRT-P (P010015/S358) | Medtronic, Inc. | 2018-04-03 |
| Forify, Fortify Assura (P910023/S407) | ABBOTT MEDICAL | 2018-04-03 |
| CapSure Fix Novus Lead; Vitatron Crystalline Active Fixation Lead (P930039/S181) | Medtronic, Inc. | 2018-04-03 |
| CapSure Fix MRI Lead (P090013/S271) | Medtronic, Inc. | 2018-04-03 |
| Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG (P980035/S538) | Medtronic, Inc. | 2018-04-03 |
| VenaSeal Closure System (P140018/S010) | Medtronic Vascular, Inc. | 2018-04-03 |
| Unify, Unify Quadra, Unify Assura, Quadra Assura and Quadra Assura MP (P030054/S352) | ABBOTT MEDICAL | 2018-04-03 |
| Consulta CRT-D, Procteca CRT-D, Protecta XT CRT-D (P010031/S619) | Medtronic Cardiac Rhythm Disease Management | 2018-04-03 |
| Tendril SDX/ST/STS and Optisense Leads (LV Active) (P960013/S090) | ABBOTT MEDICAL | 2018-04-02 |
| Advisa DR IPG, Advisa DR MIR IPG and Advisa SR MRI IPG (P980035/S532) | Medtronic, Inc. | 2018-04-02 |
| QuickFlex u and Quartet leads (P030054/S323) | ABBOTT MEDICAL | 2018-04-02 |
| Tendril MRI Leads (MRI) (P140033/S002) | ABBOTT MEDICAL | 2018-04-02 |
| Consulta , Syncra and Viva CRT-P (P010015/S353) | Medtronic, Inc. | 2018-04-02 |
| Durata and Optisure Leads (HV Active and Passive) (P950022/S102) | ABBOTT MEDICAL | 2018-04-02 |
| IsoFlex Optim Leads (lV Passive) (P960030/S052) | ABBOTT MEDICAL | 2018-04-02 |
| LiveWire TC Steerable Electrophysiology Catheter (P960016/S074) | St Jude Medical | 2018-04-02 |
| GORE CARDIOFORM Septal Occluder (P050006/S060) | W. L. Gore & Associates, Inc. | 2018-03-30 |
| VASCADE VASCULAR CLOSURE SYSTEM (VCS) (P120016/S021) | Cardiva Medical, Inc. | 2018-03-30 |
| Inlexa 7 VR-T, Inlexa 3 VR-T, Llivia 7 VR-T, Intica 7 VR-T, Intica 5 VR-T, Iperia 7 VR-T, Itrevia 5 VR-T, Inventra 7 VR- (P050023/S118) | Biotronik, Inc. | 2018-03-30 |
| Edwards SAPIEN 3 Transcatheter Heart Valves (P140031/S060) | Edwards Lifesciences, LLC | 2018-03-29 |
| LiveWire TC Steerable Electrophysiology Catheter (P960016/S073) | St Jude Medical | 2018-03-29 |
| Trifecta Valve/Trifecta Valve with Glide Technology (Trifecta GT) (P100029/S032) | ABBOTT MEDICAL | 2018-03-29 |
| ELCA Laser Catheters (P910001/S103) | Spectranetics Corp. | 2018-03-29 |
| Carpentier-Edwards PERIMOUNT Magna Pericardial Aortic Bioprosthesis/with ThermaFix tissue process; Carpentier-Edwards PE (P860057/S176) | Edwards Lifesciences, LLC | 2018-03-29 |
| Edwards SAPIEN XT Transcatheter Heart Valves (P130009/S085) | Edwards Lifesciences, LLC | 2018-03-29 |
| Edwards Intuity Elite Valve System (P150036/S026) | Edwards Lifesciences, LLC | 2018-03-29 |
| WEBSTER Catheter / CELSIUS Catheter (P950005/S069) | Biosense Webster, Inc. | 2018-03-28 |
| Edwards Sapien 3 Transcatheter Heart Valve (P140031/S063) | Edwards Lifesciences, LLC | 2018-03-28 |
| TRYTON Side Branch Stent (P150039/S003) | Poseidon Medical, Inc. | 2018-03-28 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and Over-the-Wire) (P150003/S038) | Boston Scientific Corporation | 2018-03-28 |
| Mitroflow Aortic Pericardial Heart Valve (P060038/S031) | Corcym Canada Corp | 2018-03-28 |
| Edwards Sapien XT Transcatheter Heart Valve (P130009/S088) | Edwards Lifesciences, LLC | 2018-03-28 |
| Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) EMBLEM MRI S-ICD and S-ICD Pulse Generator (P110042/S105) | Boston Scientific Corporation | 2018-03-28 |
| Edwards Pericardial Aortic Bioprosthesis, Edwards Inspiris Resilia Aortic Valve (P150048/S018) | Edwards Lifesciences, LLC | 2018-03-27 |
| Edwards Intuity Elite Valve System (P150036/S027) | Edwards Lifesciences, LLC | 2018-03-27 |
| Primo MRI DR/VR SureScan; Mirro MRI DR/VR SureScan (P980016/S659) | Medtronic Cardiac Rhythm Disease Management | 2018-03-27 |
| VenaSeal Closure System (P140018/S009) | Medtronic Vascular, Inc. | 2018-03-27 |
| Carpentier-Edwards Perimount Pericardial Aortic Bioprosthesis, Carpentier-Edwards Perimount Theon Percardial Aortic Biop (P860057/S175) | Edwards Lifesciences, LLC | 2018-03-27 |
| Durata and Optisre Family of High Voltage Leads (P950022/S116) | ABBOTT MEDICAL | 2018-03-27 |
| Gore Cardioform Septal Occluder (P050006/S062) | W. L. Gore & Associates, Inc. | 2018-03-26 |
| Latitude Programming System (P910077/S165) | Boston Scientific | 2018-03-26 |
| Invive, Intua, Visionist, Valitude (P030005/S172) | Guidant Corp. | 2018-03-26 |
| Cognis, Energen, Punctua, Incepta, Origen, Inogen, Dynagen, Autogen, Resonate, Momentum, Vigiliant, Perciva (P010012/S477) | Boston Scientific Corp | 2018-03-26 |
| TactiCath Quartz Set (P130026/S028) | St Jude Medical | 2018-03-26 |
| Teligen, Energen, Punctua, Incepta, Origen, Inogen, Dynagen, Autogen, Resonate, Momentum, Vigilant, Perciva (P960040/S418) | Boston Scientific | 2018-03-26 |
| Ingenio MRI, Vitalio MRI, Formio MRI, Essentio MRI, Proponent MRI, Accolade MRI (P150012/S052) | Boston Scientific | 2018-03-26 |
| Advantio, Ingenio, Vitalio, Formio, Essentio, Accolade, Proponent (N970003/S224) | Boston Scientific Corp | 2018-03-26 |
| SYNERGY Everolimus-Eluting Platinum Chronium Coronary Stent System (P150003/S032) | Boston Scientific Corporation | 2018-03-23 |
| Gore Cardioform Septal Occluder (P050006/S063) | W. L. Gore & Associates, Inc. | 2018-03-23 |
| Excluder AAA Endoprosthesis (P020004/S151) | W. L. Gore & Associates, Inc. | 2018-03-22 |
| Coseal Surgical Sealant Spray Set (P030039/S022) | Baxter Bio Science | 2018-03-22 |
| Coseal Surgical Sealant (P030039/S020) | Baxter Bio Science | 2018-03-22 |
| Impella CP System (P140003/S026) | Abiomed, Inc. | 2018-03-22 |
| ProCol Vascular Bioprosthesis (P020049/S005) | LeMaitre Vascular, Inc. | 2018-03-22 |
| RSONATE, MOMENTUM and VIGILANT NG4 CRT-DS (P010012/S480) | Boston Scientific Corp | 2018-03-22 |
| FlexAbility Ablation Catheter, Sensor Enabled (P110016/S050) | ABBOTT MEDICAL | 2018-03-22 |
| RESONATE, MOMENTUM, VIGILANT, and PERCIVA NG4 ICDs (P960040/S421) | Boston Scientific | 2018-03-22 |
| QuickFlex u, Quartet (P030054/S350) | ABBOTT MEDICAL | 2018-03-21 |
| Gore Tag Thoracic Endoprosthesis (P040043/S098) | W. L. Gore & Associates, Inc. | 2018-03-21 |
| IsoFlex (P960030/S058) | ABBOTT MEDICAL | 2018-03-21 |
| Tendril SDX, OptiSense, Tendril STS, Tendril ST (P960013/S097) | ABBOTT MEDICAL | 2018-03-21 |
| Attesta DR MRI SueScan, Attesta L DR MRI SureScan, Attesta S DR MRI SureScan, Attesta SR MRI SureScan, Sphera DR MRI Sur (P980035/S537) | Medtronic, Inc. | 2018-03-21 |
| Durata, Optisure (P950022/S118) | ABBOTT MEDICAL | 2018-03-21 |
| Gore Excluder AAA Endoprosthesis (P020004/S150) | W. L. Gore & Associates, Inc. | 2018-03-21 |
| OptiSense; Tendril STS, Tendril SDX, Tendril ST (P960013/S096) | ABBOTT MEDICAL | 2018-03-20 |
| S.M.A.R.T. Control Nitinol Stent System (P020036/S038) | Cordis US Corporation | 2018-03-20 |
| Platinium CRT-D 1741; Platinium 4LV CRT-D 1744 (P060027/S094) | MicroPort CRM USA, Inc. | 2018-03-20 |
| 6996T Tunneling Tool Sterile Barrier System (P920015/S208) | Medtronic, Inc. | 2018-03-20 |
| S.M.A.R.T. and S.M.A.R.T. Control Vascular Stent Systems (P120002/S013) | Cordis US Corporation | 2018-03-20 |
| Tendril (P140033/S027) | ABBOTT MEDICAL | 2018-03-20 |
| Platinium VR 1240; Platinium DR 1540 (P980049/S129) | MicroPort CRM USA, Inc. | 2018-03-20 |
| QuickFlex, Quartet (P030054/S349) | ABBOTT MEDICAL | 2018-03-20 |
| IsoFlex (P960030/S057) | ABBOTT MEDICAL | 2018-03-20 |
| Durata, Optisure (P950022/S117) | ABBOTT MEDICAL | 2018-03-20 |
| Precise Nitinol Stent Systems (P030047/S035) | Cordis US Corporation | 2018-03-20 |
| ROTAPRO Advancer; ROTAPRO; ROTAPRO Console (P900056/S166) | Boston Scientific Corp | 2018-03-19 |
| WATCHMAN Left Atrial Appendage CLosure (LAAC) Device with Delivery System (P130013/S018) | Boston Scientific Corp | 2018-03-19 |
| CapSure Sense Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead, and Vitatron Excellence + Lead (P830061/S154) | Medtronic Cardiac Rhythm Disease Management | 2018-03-16 |
| End Cap and Upsizing Sleeve (P900061/S148) | Medtronic Cardiac Rhythm Disease Management | 2018-03-16 |
| Edwards Pericardial Aortic Bioprosthesis and INSPIRIS RESILIA Aortic Valve (P150048/S009) | Edwards Lifesciences, LLC | 2018-03-16 |
| CapSure VDD 2 Lead, Servuce Kit-Pacemaker Repair Kit, and Vitatron Brilliant S+ VDD Lead (P890003/S387) | Medtronic, Inc. | 2018-03-16 |
| Transvene CS/SVC Lead (P980050/S114) | Medtronic, Inc. | 2018-03-16 |
| SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-t) SYSTEM (P030011/S060) | Syncardia Systems, LLC | 2018-03-16 |
| Anchoring Sleeve Kit and SelectSecure Lead (P030036/S099) | Medtronic Cardiac Rhythm Disease Management | 2018-03-16 |
| CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead, and Vitatron Pirouet Lead (P930039/S180) | Medtronic, Inc. | 2018-03-16 |
| RF Marinr, Unipolar Mapping RF Marinr, RF Conductr MC, RF Enhancr, and RF Contactr (P930029/S059) | Medtronic, Inc. | 2018-03-16 |
| Myocardial Pacing Lead (P120017/S012) | Medtronic, Inc. | 2018-03-16 |
| Attain Ability Lead and Attain Performa Lead (P080006/S118) | Medtronic, Inc. | 2018-03-16 |
| CapSure Epicardial Pacing Lead (P950024/S078) | Medtronic, Inc. | 2018-03-16 |
| Attain StarFix Lead (P060039/S084) | Medtronic, Inc. | 2018-03-16 |
| Wolverine Coronary Cutting Balloon Monorail (MR) and Over-the-Wire (OTW) (P950020/S089) | Boston Scientific Corp | 2018-03-16 |
| DF-1 Connector Port Pin Plug, IS-1 COnnector Port Pin Plug Kit, Springt Quattro Lead, Subcutaneous Lead, and Transvene C (P920015/S207) | Medtronic, Inc. | 2018-03-16 |
| CapSure SP and Z Novus Lead, Vitatron Excellence SS+ Lead and Vitatron Impulse II Lead (P850089/S130) | Medtronic Cardiac Rhythm Disease Management | 2018-03-16 |
| Resolute Onyx Coronary Stent System (P160043/S011) | Medtronic Vascular | 2018-03-15 |
| HeartWare Ventricular Assist System (P100047/S111) | Medtronic | 2018-03-15 |
| Arctic Front Advance Cardiac CryoAblation Catheter (P100010/S075) | Medtronic Cryocath, LP | 2018-03-15 |