| Cardiac Resynchronization Therapy-Defibrillator (CRT-D) (P060027/S101) | MicroPort CRM USA, Inc. | 2020-06-24 |
| (MBX, MHY, NHL, PJS) -Master Percept and Activa Deep Brain Stimulation Therapy Systems (P960009/S361) | Medtronic, Inc. | 2020-06-24 |
| Restylane Refyne and Restylane Defyne Injectable Gels (P140029/S022) | Q-Med AB | 2020-06-24 |
| cobas HPV Mg/Mn (P100020/S052) | Roche Molecular Systems, Inc. | 2020-06-24 |
| C-flex Intraocular Lens, C-flex Aspheric Intraocular Lens, 6.0 mm Aspheric Intraocular Lens, and RayOneAspheric the lens (P060011/S024) | Rayner Intraocular Lenses , Ltd. | 2020-06-24 |
| Implantable Cardioverter Defibrillator (ICD) (P980049/S135) | MicroPort CRM USA, Inc. | 2020-06-24 |
| Lifeline/ReviveR, Lifeline/ReviveR Auto, Lifeline/ReviveR VIEW, Lifeline/ReviveR VIEW AUTO, Lifeline/ReviveR ECG, and Li (P160032/S007) | Defibtech, LLC | 2020-06-23 |
| Arctic Front Advance, Arctic Front Advance Pro and Freezor MAX Cardiac Cryoablation Catheters (P100010/S098) | Medtronic Cryocath, LP | 2020-06-23 |
| Carpentier-Edwards PERIMOUNT Magna Ease Aortic Heart Valve (P860057/S197) | Edwards Lifesciences, LLC | 2020-06-23 |
| Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Sphera DR MRI IPG, Sphera SR MRI IPG (P980035/S630) | Medtronic, Inc. | 2020-06-23 |
| Attain Stability Quard MRI Lead (P080006/S148) | Medtronic, Inc. | 2020-06-23 |
| HeartWare Ventricular Assist System (P100047/S164) | Medtronic | 2020-06-22 |
| ADVIA Centaur HCV, and Atellica HCV (P030056/S017) | Siemens Healthcare Diagnostics | 2020-06-21 |
| Imageready MR Conditional Pacing System and Ingevity Pace/Sense Lead (P150012/S095) | Boston Scientific | 2020-06-19 |
| Bellafill Dermal Filler (P020012/S036) | Tiger Aesthetics Medical, LLC | 2020-06-19 |
| COBRA PzF NanoCoated Coronary Stent System (P160014/S015) | Celonova Biosciences, Inc. | 2020-06-18 |
| LIFEPAK Automated External Defibrillators (AEDs) (P160026/S019) | Physio-Control, Inc. | 2020-06-18 |
| Isoflex (P960030/S069) | ABBOTT MEDICAL | 2020-06-18 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S437) | Medtronic, Inc. | 2020-06-18 |
| cobas® EZH2 Mutation Test (P200014) | Roche Molecular System, Inc. | 2020-06-18 |
| Tendril MRl (P140033/S059) | ABBOTT MEDICAL | 2020-06-18 |
| Inspire IV IPG (P130008/S053) | Inspire Medical Systems | 2020-06-18 |
| Durata and Optisure High Voltage Leads (P950022/S133) | ABBOTT MEDICAL | 2020-06-18 |
| digene HC2 High-Risk HPV DNA Test and digene HC2 HPV DNA Test (P890064/S041) | Qiagen Gaithersburg, Inc. | 2020-06-18 |
| Tendril SDX, OptiSense, Tendril STS, Tendril ST (P960013/S113) | ABBOTT MEDICAL | 2020-06-18 |
| NexGen LPS-Flex / LPS Mobile Bearing Knee System (P060037/S063) | Zimmer, Inc. | 2020-06-18 |
| Quickflex µ, Quartet (P030054/S379) | ABBOTT MEDICAL | 2020-06-18 |
| Artic Front Advance Pro Cardiac Cryoablation Catheter (P100010/S105) | Medtronic Cryocath, LP | 2020-06-18 |
| DIAMONDBACK 360 Coronary Orbital Atherectomy System (OAS) (P130005/S029) | Cardiovascular Systems, Inc. | 2020-06-18 |
| Micra Transcatheter Pacing System (P150033/S070) | Medtronic, Inc. | 2020-06-17 |
| GEM215 Growth Factor Enhanced Matrix (P040013/S023) | Lynch Biologics, LLC | 2020-06-17 |
| OptiSense Steroid Eluting Cardiac Lead (P960013/S112) | ABBOTT MEDICAL | 2020-06-17 |
| LifeVest Wearable Defibrillator (P010030/S139) | Zoll Manufacturing Corporation | 2020-06-17 |
| Mara Water Vapor Ablation System (P160047/S008) | CooperSurgical, Inc. | 2020-06-17 |
| IntellaNav XP and IntellaNav MiFi XP ablation catheters (P020025/S128) | Boston Scientific | 2020-06-17 |
| LOTUS Edge Valve System (P180029/S022) | Boston Scientific Corporation | 2020-06-17 |
| LCS Total Knee System (P830055/S247) | Depuy, Inc. | 2020-06-16 |
| Clareon lntraocular Lenses with the AutonoMe Delivery System (P190018/S004) | Alcon Laboratories, LLC | 2020-06-16 |
| Rotablator Rotational Atherectomy System, ROTAPRO Rotational Atherectomy System (P900056/S185) | Boston Scientific Corp | 2020-06-16 |
| VISTAKON (Senofilcon A) Brand Contact Lenses (P040045/S115) | Vistakon, Division of Johnson & Johnson Vision Car | 2020-06-16 |
| FoundationOne CDx (F1CDx) (P170019/S016) | Foundation Medicine, Inc. | 2020-06-16 |
| AMS 800 Series Product Line/Artificial Urinary Sphincter with and without InhibiZone Treatment (P000053/S113) | Boston Scientific Corp | 2020-06-16 |
| AMS 700 Series Product Line/Inflatable Penile Prosthesis (IPP) with and without Inhibizone Treatment (N970012/S178) | Boston Scientific Corp | 2020-06-16 |
| ReActiv8 Implantable Neurostimulation System (P190021) | Mainstay Medical Limited | 2020-06-16 |
| Alto Abdominal Stent Graft System (P120006/S035) | Endologix, LLC | 2020-06-16 |
| Cologuard (P130017/S041) | Exact Sciences Corporation | 2020-06-15 |
| (Pacemaker Devices) ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT, ALTRUA, INSIGNIA I, NEXUS I (N970003/S251) | Boston Scientific Corp | 2020-06-15 |
| (CRT-P Resynchronization Devices) INVIVE, INTUA, VISIONIST, VALITUDE (P030005/S197) | Guidant Corp. | 2020-06-15 |
| (Pacemaker Devices) INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI (P150012/S092) | Boston Scientific | 2020-06-15 |
| iSert Preloaded Posterior Chamber One-Piece Intraocular Lens (IOL) (P080004/S034) | Hoya Surgical Optics, Inc. | 2020-06-15 |
| Apollo Onyx Delivery Micro Catheter (P030004/S017) | Ev3 Neurovascular | 2020-06-15 |
| LATITUDE Programming System, Altrua/Insignia I/Nexus I (P910077/S177) | Boston Scientific | 2020-06-15 |
| Orsiro Sirolimus Eluting Coronary Stent System (P170030/S006) | Biotronik AG | 2020-06-15 |
| (ICD Devices) TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT, PERCIV (P960040/S450) | Boston Scientific | 2020-06-15 |
| (CRT-D Resynchronization Devices) COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTU (P010012/S518) | Boston Scientific Corp | 2020-06-15 |
| LCS Total Knee System (P830055/S248) | Depuy, Inc. | 2020-06-15 |
| HeartMate 3 (HM3) Left Ventricular Assist System (LVAS) (P160054/S030) | ABBOTT MEDICAL | 2020-06-13 |
| WOLVERINE Coronary Cutting Balloon (P950020/S108) | Boston Scientific Corp | 2020-06-12 |
| Inspire Upper Airway Stimulation (P130008/S052) | Inspire Medical Systems | 2020-06-12 |
| Innova Vascular Self-Expanding Stent System (P140028/S060) | Boston Scientific Corporation | 2020-06-12 |
| LATITUDE Wave Communicators (P910077/S179) | Boston Scientific | 2020-06-12 |
| ELUVIA Drug-Eluting Vascular Stent System (P180011/S032) | Boston Scientific Corp | 2020-06-12 |
| Juvederm Voluma XC for Chin Augmentation (P110033/S047) | Allergan | 2020-06-12 |
| BD Onclarity HPV Assay (P160037/S004) | Becton, Dickinson and Company | 2020-06-12 |
| Aptima HPV 16 18/45 Genotype Assay (P120007/S027) | Gen-Probe Incorporated | 2020-06-11 |
| TECNIS Toric 1-Piece Intraocular Lenses (IOL) (P980040/S111) | Johnson & Johnson Surgical Vision, Inc. | 2020-06-11 |
| Evolut R, Evolut PRO and Evolut PRO+ Transcatheter Aortic Valves (TAV)s (P130021/S077) | Medtronic, Inc. | 2020-06-11 |
| LOTUS Edge Valve System (P180029/S024) | Boston Scientific Corporation | 2020-06-11 |
| X Series and Propaq MD (P160022/S018) | ZOLL Medical Corporation | 2020-06-11 |
| Perceval Sutureless Heart Valve and Perceval Plus Sutureless Heart Valve (P150011/S020) | Corcym S.r.l. | 2020-06-11 |
| Aptima HPV Assay (P100042/S030) | Gen-Probe Incorporated | 2020-06-11 |
| Rayner C-flex, C-flex Aspheric, Aspheric Intracular lenses and RayOne Aspheric (P060011/S022) | Rayner Intraocular Lenses , Ltd. | 2020-06-10 |
| HEMOBLAST Bellows (P170012/S022) | Dilon Technologies, Inc. | 2020-06-10 |
| Alinity m HCV (P190025/S002) | Abbott Molecular, Inc. | 2020-06-09 |
| Promus Premier, Promus Elite Everolimus-Eluting Platinum Chromium Coronary Stent (P110010/S179) | Boston Scientific Corp | 2020-06-09 |
| Activa Deep Brain Stimulation Therapy System (P960009/S375) | Medtronic, Inc. | 2020-06-09 |
| Implantable System for Remodulin (P140032/S056) | Medtronic, Inc. | 2020-06-09 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S062) | Boston Scientific Corporation | 2020-06-09 |
| Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul (P840001/S462) | Medtronic Neuromodulation | 2020-06-09 |
| InterStim Therapy System and Verify Evaluation System (SNS Bowel) (P080025/S206) | Medtronic Neuromodulation | 2020-06-09 |
| InterStim Therapy System and Verify Evaluation System (SNS Urinary) (P970004/S311) | Medtronic Neuromodulation | 2020-06-09 |
| SynchroMed Infusion System and Ascenda Intrathecal Catheters (P860004/S359) | Medtronic, Inc. | 2020-06-09 |
| Consulta CRT-P,Percepta Bipolar CRT-P,Percepta Quadripolar CRT-P,Serena Bipolar CRT-P,Serena Quadripolar CRT-P,Solara Bi (P010015/S436) | Medtronic, Inc. | 2020-06-08 |
| Amplia MRI CRTD-D,Amplia MRI Quad CRT-D,Brava CRT-D,Brava Quad CRT-D,Claria MRI CRT-D,Claria MRI Quad CRT-D,Cobalt MRI C (P010031/S702) | Medtronic Cardiac Rhythm Disease Management | 2020-06-08 |
| 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,Astra X (P980035/S627) | Medtronic, Inc. | 2020-06-08 |
| 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,Evera XT D (P980016/S741) | Medtronic Cardiac Rhythm Disease Management | 2020-06-08 |
| Progensa PCA3 Assay (P100033/S011) | Gen-Probe Incorporated | 2020-06-08 |
| Micra AV TPS, Micra TPS (P150033/S074) | Medtronic, Inc. | 2020-06-08 |
| TriVisc (P160057/S001) | Channel-Markers Medical, LLC | 2020-06-07 |
| GenVisc 850 (P140005/S004) | Channel-Markers Medical, LLC | 2020-06-07 |
| Alinity i HBsAg Qualitative II Reagent Kit and Alinity i HBsAg Qualitative II Confirmatory Kit (P110029/S030) | Abbott Laboratories | 2020-06-05 |
| NexGen LPS-Flex and LPS-Mobile Bearing Knee (P060037/S064) | Zimmer, Inc. | 2020-06-05 |
| Alinity i Anti-HCV Reagent Kit (P050042/S040) | Abbott Laboratories, Inc. | 2020-06-05 |
| AED 3 Defibrillator with Uni-Padz (P160015/S004) | ZOLL Medical Corporation | 2020-06-05 |
| Proclaim DRG IPG (P150004/S033) | ABBOTT MEDICAL | 2020-06-05 |
| Alinity i Anti-HBc IgM Reagent Kit (P060035/S028) | Abbott Laboratories | 2020-06-05 |
| KARL STORZ Photodynamic D-Light C PDD System (P050027/S021) | KARL STORZ Endoscopy-America, Inc. | 2020-06-05 |
| Alinity i Free PSA assay (P980007/S041) | Abbott Laboratories | 2020-06-05 |
| Alinity i Anti-HBc Reagent Kit (P080023/S031) | Abbott Laboratories | 2020-06-05 |
| Proclaim family of SCS IPGs (P010032/S156) | ABBOTT MEDICAL | 2020-06-05 |