| SYNERGY XD Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY XD Everolimus-Eluting Platinum Chromium C (P150003/S066) | Boston Scientific Corporation | 2020-11-30 |
| InterStim Therapy System, Verify Evaluation System (SNS Urinary) (P080025/S216) | Medtronic Neuromodulation | 2020-11-30 |
| DUROLANE (P170007/S007) | Bioventus, LLC | 2020-11-29 |
| LCS Total Knee System (P830055/S259) | Depuy, Inc. | 2020-11-27 |
| Inspire Upper Airway Stimulator (P130008/S057) | Inspire Medical Systems | 2020-11-27 |
| LifePulse High Frequency Ventilator (P850064/S043) | Bunnell, Inc. | 2020-11-25 |
| LIAISON QuantiFERON-TB Gold Plus (P180047/S006) | DiaSorin, Inc. | 2020-11-25 |
| Sodium Hyaluronate Ophthalmic Viscoelastic Device (OVD), Healon GV PRO (P810031/S066) | Johnson & Johnson Surgical Vision, Inc. | 2020-11-25 |
| 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 IPG (P980035/S662) | Medtronic, Inc. | 2020-11-25 |
| Cologuard (P130017/S045) | Exact Sciences Corporation | 2020-11-25 |
| Juvéderm Voluma XC, Juvéderm Vollure XC, and Juvéderm Volbella XC (P110033/S057) | Allergan | 2020-11-25 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S457) | Medtronic, Inc. | 2020-11-25 |
| GORE VIATORR TIPS Endoprosthesis, GORE VIATORR TIPS Endoprosthesis with Controlled Expansion (P040027/S080) | W. L. Gore & Associates, Inc. | 2020-11-25 |
| Juvéderm Ultra, Juvéderm Ultra XC, Juvéderm Ultra Plus, and Juvéderm Ultra Plus XC (P050047/S079) | Allergan | 2020-11-25 |
| Clareon Intraocular Lenses with the AutonoMe Delivery System (P190018/S008) | Alcon Laboratories, LLC | 2020-11-24 |
| Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Sphera DR MRI IPG, Sphera SR MRI IPG (P980035/S661) | Medtronic, Inc. | 2020-11-24 |
| Patient-Fitted TMJ Reconstruction Prosthesis System (P980052/S008) | Stryker Leibinger, GmbH & Co KG | 2020-11-24 |
| IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter (P190008/S008) | Medtronic Vascular, Inc. | 2020-11-24 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S029) | Medinol, Ltd. | 2020-11-24 |
| IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter (P140010/S054) | Medtronic, Inc. | 2020-11-24 |
| HeartWare Ventricular Assist System (P100047/S159) | Medtronic | 2020-11-23 |
| VISTAKON (senofilcon A) ACUVUE OASYS Brand Contact Lenses for ASTIGMATISM with HYDRACLEAR Plus (P040045/S119) | Vistakon, Division of Johnson & Johnson Vision Car | 2020-11-23 |
| VisuMax Femtosecond Laser (P150040/S007) | Carl Zeiss Meditec, Inc. | 2020-11-23 |
| Rotablator Rotational Atherectomy System and ROTAPRO Rotational Atherectomy System (P900056/S191) | Boston Scientific Corp | 2020-11-23 |
| WOLVERINE Cutting Balloon Micro-Surgical Dilation Catheter (P950020/S110) | Boston Scientific Corp | 2020-11-20 |
| Cardiac Resynchronization Therapy (CRT) (P030054/S387) | ABBOTT MEDICAL | 2020-11-20 |
| AtriCure Synergy Ablation System (P100046/S011) | AtriCure, Inc. | 2020-11-20 |
| Tendril MRI (P140033/S062) | ABBOTT MEDICAL | 2020-11-20 |
| TherOx DownStream System (P170027/S001) | Zoll Circulation, Inc. | 2020-11-20 |
| InterStim Therapy System, Verify Evaluation System, InterStim Micro Implantable Neurostimulator (SNS Urinary) (P970004/S320) | Medtronic Neuromodulation | 2020-11-19 |
| Bausch + Lomb Ultra (samfilcon A) Visibility Tinted Soft (hydrophilic) Contact Lenses (P170035/S011) | Bausch and Lomb, Inc., | 2020-11-19 |
| Restore, Itrel, Synergy and Intellis, Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimu (P840001/S473) | Medtronic Neuromodulation | 2020-11-19 |
| SYNERGY Everolimus-Eluting Platinum Chromium Stent System, SYNERGY XD Everolimus-Eluting Platinum Chromium Coronary Sten (P150003/S067) | Boston Scientific Corporation | 2020-11-19 |
| InterStim Therapy System, Verify Evaluation System, InterStim Micro Implantable Neurostimulator (SNS Bowel) (P080025/S215) | Medtronic Neuromodulation | 2020-11-19 |
| Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System, Promus ELITE Everolimus-Eluting Platinum Coro (P110010/S184) | Boston Scientific Corp | 2020-11-19 |
| COBRA PzF NanoCoated Coronary Stent System (P160014/S017) | Celonova Biosciences, Inc. | 2020-11-19 |
| Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense Implantable Neurostimulator (P960009/S388) | Medtronic, Inc. | 2020-11-19 |
| Implantable System for Remodulin (P140032/S062) | Medtronic, Inc. | 2020-11-19 |
| VISTAKON (etafilcon A) Brand Contact Lenses (N18033/S108) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2020-11-19 |
| IDEAL IMPLANT Structured Breast Implant (P120011/S017) | Bimini Health Tech | 2020-11-19 |
| Zephyr Endobronchial Valve System (P180002/S017) | Pulmonx Corporation | 2020-11-19 |
| CERAMAX Ceramic Total Hip System (P070026/S077) | DePuy Orthopaedics, Inc. | 2020-11-19 |
| VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S120) | Vistakon, Division of Johnson & Johnson Vision Car | 2020-11-19 |
| SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S364) | Medtronic, Inc. | 2020-11-19 |
| Express SD Renal Premounted Stent System (P060006/S102) | Boston Scientific Corp | 2020-11-18 |
| Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic - Microfibrillar Form (P810006/S091) | Integra LifeSciences Corporation | 2020-11-18 |
| CapSureFix MRI Lead (P090013/S310) | Medtronic, Inc. | 2020-11-18 |
| Defibtech Automated External Defibrillator (AED) Systems (P160032/S003) | Defibtech, LLC | 2020-11-18 |
| CapSure Sense Lead, CapSure SP Novus Lead, and Vitatron Crystalline Lead (P830061/S186) | Medtronic Cardiac Rhythm Disease Management | 2020-11-18 |
| CollaCote, CollaTape, and CollaPlug Absorbable Collagen Wound Dressings for Dental Surgery (P840062/S077) | Integra Lifesciences Corp. | 2020-11-18 |
| Express LD Iliac Premounted Stent System (P090003/S050) | Boston Scientific Corporation | 2020-11-18 |
| Micra AV TPS and Micra TPS (P150033/S087) | Medtronic, Inc. | 2020-11-18 |
| Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation System and Pisces, Specify, and Vectris Spinal Cord Stimula (P840001/S474) | Medtronic Neuromodulation | 2020-11-18 |
| Attain Ability Lead, Attain Performa Lead, and Attain Stability Quad MRI Lead (P080006/S152) | Medtronic, Inc. | 2020-11-18 |
| 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, Cobalt (P010031/S721) | Medtronic Cardiac Rhythm Disease Management | 2020-11-18 |
| SelectSecure Lead (P030036/S124) | Medtronic Cardiac Rhythm Disease Management | 2020-11-18 |
| Attain Bipolar OTW Lead, Attain OTW LV Lead, Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena (P010015/S455) | Medtronic, Inc. | 2020-11-18 |
| CapSureFix Lead, CapSureFix Novus Lead, and Vitatron Crystalline Active Fixation Lead (P930039/S217) | Medtronic, Inc. | 2020-11-18 |
| HV Splitter/Adaptor Kit, IS-1 Connector Port Pin Plug Kit, Sprint Quattro Lead, Subcutaneous Lead, and Transvene CS/SVC (P920015/S247) | Medtronic, Inc. | 2020-11-18 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve (P980016/S760) | Medtronic Cardiac Rhythm Disease Management | 2020-11-18 |
| LifeVest Wearable Defibrillator (P010030/S143) | Zoll Manufacturing Corporation | 2020-11-18 |
| CapSure VDD-2 Lead, CareLink SmartSync Device Manager Programmer and Vitatron Brilliant S+ VDD Lead (P890003/S436) | Medtronic, Inc. | 2020-11-18 |
| Myocardial Pacing Lead (P120017/S024) | Medtronic, Inc. | 2020-11-18 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera (P980016/S758) | Medtronic Cardiac Rhythm Disease Management | 2020-11-18 |
| Activa Deep Brain Stimulation Therapy System (P960009/S389) | Medtronic, Inc. | 2020-11-18 |
| samaritan Public Access Automated External Defibrillators and Accessories (P160008/S015) | Heartsine Technologies, Ltd. | 2020-11-18 |
| Attain StarFix Lead (P060039/S102) | Medtronic, Inc. | 2020-11-18 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, and Crome MRI CRT-D (P010031/S722) | Medtronic Cardiac Rhythm Disease Management | 2020-11-18 |
| Implantable System for Remodulin (P140032/S061) | Medtronic, Inc. | 2020-11-18 |
| 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/S658) | Medtronic, Inc. | 2020-11-18 |
| CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, and Vitatron Impulse II Lead (P850089/S150) | Medtronic Cardiac Rhythm Disease Management | 2020-11-18 |
| SynchroMed Intrathecal Catheters (P860004/S363) | Medtronic, Inc. | 2020-11-18 |
| CapSure Epicardial Pacing Lead (P950024/S095) | Medtronic, Inc. | 2020-11-18 |
| Integra Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template and Integra Omnigraft Dermal Regenerat (P900033/S091) | Integra Lifesciences Corp. | 2020-11-18 |
| 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, Cobalt (P010031/S719) | Medtronic Cardiac Rhythm Disease Management | 2020-11-18 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, and Crome MRI ICD (P980016/S761) | Medtronic Cardiac Rhythm Disease Management | 2020-11-18 |
| Transvene CS/SVC Lead (P980050/S129) | Medtronic, Inc. | 2020-11-18 |
| Cerene Cryotherapy Device (P180032/S002) | Channel Medsystems, Inc. | 2020-11-18 |
| HeartWare Left Ventricular Assist System (P100047/S163) | Medtronic | 2020-11-18 |
| Deflux Injectable Gel (P000029/S091) | Palette Life Sciences | 2020-11-18 |
| Helistat and Helitene Absorbable Collagen Hemostatic Agents (P850010/S091) | Integra LifeSciences Corporation | 2020-11-18 |
| Percepta Quadripolar CRT-P, Serena Quadripolar CRT-P, and Solara Quadripolar CRT-P (P010015/S454) | Medtronic, Inc. | 2020-11-18 |
| Epicardial Patch Lead (P900061/S161) | Medtronic Cardiac Rhythm Disease Management | 2020-11-18 |
| Surpass Evolve Flow Diverter System (P170024/S005) | Stryker Neurovascular | 2020-11-17 |
| Edora 8 HF-T QP, Edora 8 HF-T, Evity 8 HF-T QP, Evity 8 HF-T, Enitra 8 HF-T QP, Enitra 8 HF-T, Enticos 8 HF-T QP, and En (P070008/S119) | Biotronik, Inc. | 2020-11-17 |
| Biofinity (comfilcon A) XR Toric and Toric Multifocal Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S119) | CooperVision, Inc. | 2020-11-17 |
| LifeVest Wearable Defibrillator (P010030/S145) | Zoll Manufacturing Corporation | 2020-11-17 |
| Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Enticos 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6 DR, Edora 8 (P950037/S216) | Biotronik, Inc. | 2020-11-17 |
| LVIS and LVIS Jr. (P170013/S001) | MicroVention, Inc. | 2020-11-17 |
| Gel-One (P080020/S040) | Seikagaku Corp. | 2020-11-17 |
| Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Relia IPG, Sphera DR MRI IPG, and Sphera SR MRI IPG (P980035/S655) | Medtronic, Inc. | 2020-11-16 |
| Inspire II Upper Airway Stimulator (P130008/S055) | Inspire Medical Systems | 2020-11-16 |
| EMBLEM S-ICD Pulse Generator and EMBLEM MRI S-ICD Pulse Generator (P110042/S147) | Boston Scientific Corporation | 2020-11-16 |
| VALITUDE, VALITUDE X4, VISIONIST and VISIONIST X4 (P030005/S204) | Guidant Corp. | 2020-11-16 |
| ESSENTIO MRI, PROPONENT MRI, and ACCOLADE MRI (P150012/S103) | Boston Scientific | 2020-11-16 |
| ALTRUA 2, ESSENTIO, PROPONENT, and ACCOLADE (N970003/S258) | Boston Scientific Corp | 2020-11-16 |
| Protege/Prodigy/Proclaim XR family of SCS IPGs, SCS EPG and SCS Percutaneous Permanent and Trial leads (P010032/S165) | ABBOTT MEDICAL | 2020-11-15 |
| Orsiro Sirolimus Eluting Coronary Stent System (P170030/S012) | Biotronik AG | 2020-11-13 |
| PATHWAY Anti-c-KIT (9.7) Primary Antibody (P020055/S023) | Ventana Medical Systems, Inc. | 2020-11-13 |
| Orsiro Sirolimus Eluting Coronary Stent System (P170030/S013) | Biotronik AG | 2020-11-13 |