| Promus ELITE Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S160) | Boston Scientific Corp | 2018-10-31 |
| Durata and Optisure High Voltage Leads (P950022/S123) | ABBOTT MEDICAL | 2018-10-31 |
| Micra TPS (P150033/S043) | Medtronic, Inc. | 2018-10-31 |
| Melody TPV System (P140017/S011) | Medtronic, Inc. | 2018-10-30 |
| Hancock Valved Conduit Low Porosity (P870078/S043) | Medtronic, Inc. | 2018-10-28 |
| Melody (P140017/S012) | Medtronic, Inc. | 2018-10-28 |
| Hancock Valved Conduit Modified Orifice (P790007/S058) | Medtronic Heart Valves | 2018-10-28 |
| Evera MRI, ICD, DF-1 ICD, S DR ICD, XT DR ICD, XT VR ICD; Mirro MRI DR ICD, VR ICD; Primo MRI DR ICD, VR ICD; Visia AF M (P980016/S690) | Medtronic Cardiac Rhythm Disease Management | 2018-10-26 |
| Amplia MRI CRT-D, Quad CRT -D; Brava CRT-D, Quad CRT-D; Claria MRI CRT-D, Quad CRT-D; Compia MRI CRT-D, MRI Quad CRT-D; (P010031/S647) | Medtronic Cardiac Rhythm Disease Management | 2018-10-26 |
| Zoll X Series Device (Oridion MicroMediCO2) (P160022/S004) | ZOLL Medical Corporation | 2018-10-26 |
| EXCOR Pediatric Ventricular Assist Device (P160035/S004) | Berlin Heart, Inc. | 2018-10-26 |
| Edwards Commander Delivery System (P140031/S076) | Edwards Lifesciences, LLC | 2018-10-25 |
| 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/S691) | Medtronic Cardiac Rhythm Disease Management | 2018-10-24 |
| Assurity MRI, Endurity MRI, Tendril MRI, MRI Activator, (P140033/S038) | ABBOTT MEDICAL | 2018-10-24 |
| EXCLUDER AAA Endoprosthesis (P020004/S159) | W. L. Gore & Associates, Inc. | 2018-10-24 |
| 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/S649) | Medtronic Cardiac Rhythm Disease Management | 2018-10-24 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S382) | Medtronic, Inc. | 2018-10-24 |
| Micra TPS (P150033/S044) | Medtronic, Inc. | 2018-10-24 |
| Durata, Optisure (P950022/S121) | ABBOTT MEDICAL | 2018-10-24 |
| Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) Electrode (P110042/S114) | Boston Scientific Corporation | 2018-10-24 |
| Quartet, Victory, Zephyr, Accent, Assurity, Assurity+Endurity, Identity XL, Identity ADx XL, Verity ADx XL, Sustain XL D (P880086/S303) | ABBOTT MEDICAL | 2018-10-24 |
| Allure, Allure Quadra, Quadra Allure MP (P030035/S174) | ABBOTT MEDICAL | 2018-10-24 |
| CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM (P100045/S032) | ABBOTT MEDICAL | 2018-10-24 |
| IsoFlex Optim (P960030/S060) | ABBOTT MEDICAL | 2018-10-24 |
| Tendril SDX Lead, Tendril ST Lead, OptiSense, Tendril STS Lead (P960013/S101) | ABBOTT MEDICAL | 2018-10-24 |
| Microny (P970013/S079) | ABBOTT MEDICAL | 2018-10-24 |
| 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/S566) | Medtronic, Inc. | 2018-10-24 |
| Unify, Unify Quadra, Unify Assura, Quadra Assura, Quadra Assura MP, QuickFlex u, Quartet, Quartet CRT Leads (P030054/S360) | ABBOTT MEDICAL | 2018-10-24 |
| Fortify, Fortify Assura, Ellipse (P910023/S412) | ABBOTT MEDICAL | 2018-10-24 |
| HeartWare Ventricular Assist System (P100047/S130) | Medtronic | 2018-10-23 |
| HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators and Accessories (P160008/S002) | Heartsine Technologies, Ltd. | 2018-10-22 |
| Mosaic Bioprosthesis and Hancock II Bioprosthesis (P980043/S068) | Medtronic, Inc. | 2018-10-22 |
| IFORIA 5/7, ILESTO 57/, INVENTRA 7, IPERIA 5/7, ITREVIA 5/7, ILIVIA 5/7, INTICA 5/7, INLEXA 5/7, LUMAX 300/340 and 500/5 (P050023/S124) | Biotronik, Inc. | 2018-10-22 |
| PSW 1802.U, ACTROS, AXOS, BA03, CYLOS, DROMOS, KAIROS, PHILOS, PHILOS II, PROTOS, EVIA, ENTOVIS, ECURO, EFFECTA, ESTELLA (P950037/S195) | Biotronik, Inc. | 2018-10-22 |
| STRATOS, EVIA, ENTOIVS, ELUNA 8, EPYRA 8, and ETRINSA 8 (P070008/S097) | Biotronik, Inc. | 2018-10-22 |
| BELOS, LEXOS, LUMOS, and XELOS (P000009/S077) | Biotronik, Inc. | 2018-10-22 |
| Mosaic Bioprosthesis and Hancock II Bioprosthesis (P990064/S076) | Medtronic, Inc. | 2018-10-22 |
| EnVeo R and EnVeo PRO delivery catheter system (DCS) (P130021/S054) | Medtronic, Inc. | 2018-10-21 |
| 9600CR Crimper (P140031/S075) | Edwards Lifesciences, LLC | 2018-10-19 |
| Valiant Navion Thoracic Stent Graft System (P100040/S036) | Medtronic Vascular | 2018-10-19 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S039) | Boston Scientific Corporation | 2018-10-18 |
| Resolute Integrity Zotarolimus Eluting Coronary Stent System (P110013/S090) | Medtronic Vascular | 2018-10-18 |
| CapSure Epicardial Pacing Lead (P950024/S080) | Medtronic, Inc. | 2018-10-18 |
| 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, Mi (P980016/S688) | Medtronic Cardiac Rhythm Disease Management | 2018-10-18 |
| CapSure SP Novus Lead, CapSure Z Novus Lead, and Vitatron Impulse II Lead (P850089/S136) | Medtronic Cardiac Rhythm Disease Management | 2018-10-18 |
| CapSure VDD 2 Lead, Package Adaptor Cable and Vitatron Brilliant S+ VDD Lead (P890003/S397) | Medtronic, Inc. | 2018-10-18 |
| 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/S646) | Medtronic Cardiac Rhythm Disease Management | 2018-10-18 |
| Attesta MRI, Sphera MRI, Adapta, Versa, Sensia, Advisa, Advisa MRI, EnPulse and Kappa (P980035/S561) | Medtronic, Inc. | 2018-10-18 |
| Viva, Brava, Protecta, Protecta XT, COncerto, Concerto II, Consulta, Maximo II, InSync II Protect, Amplia, Compia and Cl (P010031/S644) | Medtronic Cardiac Rhythm Disease Management | 2018-10-18 |
| AED 3 BLS Device (P160022/S007) | ZOLL Medical Corporation | 2018-10-18 |
| Micra (P150033/S041) | Medtronic, Inc. | 2018-10-18 |
| Pulse Generator, Permanent Implantable (Device Reader/Interrogator) (P890003/S395) | Medtronic, Inc. | 2018-10-18 |
| SelectSecure Lead (P030036/S103) | Medtronic Cardiac Rhythm Disease Management | 2018-10-18 |
| Innova Vascular Self-Expanding Stent System (P140028/S033) | Boston Scientific Corporation | 2018-10-18 |
| Epic Vascular Self-Expanding Stent System (P110035/S047) | Boston Scientific Corp | 2018-10-18 |
| CapSure Sense Lead, CapSure SP Novus Lead and Vitatron Crystalline Lead (P830061/S162) | Medtronic Cardiac Rhythm Disease Management | 2018-10-18 |
| Y Adaptor/Extender Kit, IS-1 Connector Port Pin Plug Kit, Lead Adaptor, Sprint Quattro Lead, Subcutaneous Lead, and Tran (P920015/S218) | Medtronic, Inc. | 2018-10-18 |
| Revo MRI (P090013/S289) | Medtronic, Inc. | 2018-10-18 |
| Attain Bipolar OTW Lead, Attain OTW LV Lead, COnsulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena (P010015/S380) | Medtronic, Inc. | 2018-10-18 |
| Resolute Onyx Zotarolimus Eluting Coronary Stent System (P160043/S016) | Medtronic Vascular | 2018-10-18 |
| Perclose ProGlide Suture-Mediated Closure System (P960043/S101) | Abbott Vascular, Inc. | 2018-10-18 |
| Micra TPS (P150033/S042) | Medtronic, Inc. | 2018-10-18 |
| On-X Prosthetic Heart Valve, Model Onxa (P000037/S052) | On-X Life Technologies, Inc. | 2018-10-18 |
| 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/S564) | Medtronic, Inc. | 2018-10-18 |
| Attain Ability Lead and Attain Performa Lead (P080006/S126) | Medtronic, Inc. | 2018-10-18 |
| Evera MRI, Evera, Marquis, Secura, Maximo II, Intrinsic, Protecta, Protecta XT, Virtuoso II, VIsia AF, Primo DR and VR M (P980016/S685) | Medtronic Cardiac Rhythm Disease Management | 2018-10-18 |
| HeartMate 3 Left Ventricular Assist System (P160054/S008) | ABBOTT MEDICAL | 2018-10-18 |
| CapSureFix MRI Lead (P090013/S290) | Medtronic, Inc. | 2018-10-18 |
| CapSureFix Lead, CapSureFix Novus Lead, and Vitatron Crystalline Active Fixation Lead (P930039/S191) | Medtronic, Inc. | 2018-10-18 |
| Consulta CRT-P, Syncra CRT-P and Viva CRT-P (P010015/S378) | Medtronic, Inc. | 2018-10-18 |
| Attain StarFix Lead (P060039/S090) | Medtronic, Inc. | 2018-10-18 |
| Myocardial Pacing Lead (P120017/S014) | Medtronic, Inc. | 2018-10-18 |
| GORE Conformable TAG Thoracic Endoprosthesis (P040043/S105) | W. L. Gore & Associates, Inc. | 2018-10-17 |
| Spectranetics Laser Sheaths SLS (P960042/S064) | Spectranetics (Philips) | 2018-10-15 |
| AngioSculpt PTCA Scoring Balloon Catheter (P050018/S025) | Spectranetics Corp. | 2018-10-15 |
| Astron Stent System (P140030/S008) | Biotronik AG | 2018-10-15 |
| CVX-300 Excimer Laser System and ELCA Coronary Atherectomy Catheters (P910001/S107) | Spectranetics Corp. | 2018-10-15 |
| TactiCath Quartz Equipment (P130026/S034) | St Jude Medical | 2018-10-15 |
| GORE TAG Thoracic Endoprosthesis (P040043/S104) | W. L. Gore & Associates, Inc. | 2018-10-11 |
| GORE EXCLUDER AAA Endoprosthesis (P020004/S158) | W. L. Gore & Associates, Inc. | 2018-10-11 |
| GORE VIABAHN Endoprosthesis and Gore VIABAHN Endoprosthesis with Heparin Endoprosthesis (P040037/S122) | W. L. Gore & Associates, Inc. | 2018-10-11 |
| GORE TIGRIS Vascular Stent (P160004/S021) | W. L. Gore & Associates, Inc. | 2018-10-11 |
| Flair Endovascular Stent Graft (P060002/S040) | Bard Peripheral Vascular | 2018-10-11 |
| GORE EXCLUDER AAA Endoprosthesis (P020004/S157) | W. L. Gore & Associates, Inc. | 2018-10-11 |
| GORE VIATORR TIPS Endoprosthesis (P040027/S067) | W. L. Gore & Associates, Inc. | 2018-10-11 |
| GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P130006/S061) | W. L. Gore & Associates, Inc. | 2018-10-11 |
| GORE VIABAHN VBX Balloon Expandable Endoprostheis (P160021/S014) | W. L. Gore & Associates, Inc. | 2018-10-11 |
| LifeStream Balloon Expandable Vascular Covered Stent (P160024/S003) | Bard Peripheral Vascular, Inc. | 2018-10-11 |
| Express LD Iliac Premounted System (P090003/S044) | Boston Scientific Corporation | 2018-10-10 |
| CRT-Ds Autogen, Inogen, Dynagen, Origen, Resonate, Momentum, Vigilant, Perciva, Punctua, Energen, and Incepta (P010012/S490) | Boston Scientific Corp | 2018-10-10 |
| Express SD Renal Monorail Premounted System (P060006/S094) | Boston Scientific Corp | 2018-10-10 |
| ZENITH TX2 TAA ENDVASCULAR GRAFT (P070016/S009) | William Cook Europe Aps | 2018-10-10 |
| SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM (P110042/S115) | Boston Scientific Corporation | 2018-10-10 |
| ZENITH FLEX AAA ENDOVASCULAR GRAFT (P020018/S055) | Cook, Inc. | 2018-10-10 |
| ICDs Autogen, Inogen, Dynagen, Origen, Resonate, Momentum, Vigilant, Perciva, Punctua, Energen, and Incepta (P960040/S429) | Boston Scientific | 2018-10-10 |
| samaritan Public Access Automated External Defibrillators and Accessories (P160008/S001) | Heartsine Technologies, Ltd. | 2018-10-09 |
| QuickFlex u 1258T LV Lead (P030054/S359) | ABBOTT MEDICAL | 2018-10-09 |
| Medtronic CareLink, CareLink Encore (P890003/S398) | Medtronic, Inc. | 2018-10-05 |
| Medtronic Core Valve Evolut R and PRO R System (P130021/S053) | Medtronic, Inc. | 2018-10-05 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent Systems (P160043/S019) | Medtronic Vascular | 2018-10-05 |