| Nucleus 24 Cochlear Implant (P970051/S188) | Cochlear Americas | 2020-04-02 |
| REBEL Platinum Chromium Coronary Stent System (P130030/S068) | Boston Scientific Corp | 2020-04-02 |
| SynchroMed Infusion System and Ascenda Intrathecal Catheters (P860004/S353) | Medtronic, Inc. | 2020-04-02 |
| Senza Spinal Cord Stimulation (SCS) System (P130022/S031) | Nevro Corporation | 2020-04-02 |
| DUOVISC Ophthalmic Viscoelastic System (consists of PROVISC and VISCOAT), DISCOVISC Ophthalmic Viscosurgical Device (P840064/S071) | Alcon Laboratories | 2020-04-02 |
| Endurant, Endurant II, and Endurant lls Stent Graft System (P100021/S080) | Medtronic Vascular | 2020-04-02 |
| Sientra OPUS Silicone Gel Breast Implants (P070004/S031) | Tiger Aesthetics Medical, LLC | 2020-04-02 |
| Nucleus Hybrid Cochlear Implant (P130016/S039) | Cochlear Americas | 2020-04-02 |
| PROVISC Ophthalmic Viscosurgical Device (P890047/S054) | Alcon Research, Ltd. | 2020-04-02 |
| Amplia MRI CRTD, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRTD, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia MR (P010031/S693) | Medtronic Cardiac Rhythm Disease Management | 2020-04-02 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR/VR ICD, Evera XT DR/VR ICD, Mirro MRI DR ICD, Mirro MRI VR ICD, Primo MRI (P980016/S732) | Medtronic Cardiac Rhythm Disease Management | 2020-04-02 |
| Implantable System for Remodulin (P140032/S050) | Medtronic, Inc. | 2020-04-02 |
| VisuMax Femtosecond Laser (P150040/S005) | Carl Zeiss Meditec, Inc. | 2020-04-02 |
| ICD Devices: TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT and PERC (P960040/S446) | Boston Scientific | 2020-04-01 |
| CRT-D Resynchronization Devices: COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM (P010012/S514) | Boston Scientific Corp | 2020-04-01 |
| Biofinity Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S104) | CooperVision, Inc. | 2020-04-01 |
| LATITUDE NXT System - LATITUDE NXT Patient Management System, LATITUDE Wave Communicator and LATITUDE NXT System Server (P910077/S176) | Boston Scientific | 2020-04-01 |
| CRT-P Resynchronization Devices: INVIVE, INTUA, VISIONIST, VALITUDE (P030005/S193) | Guidant Corp. | 2020-04-01 |
| HeartWare Ventricular Assist System (P100047/S155) | Medtronic | 2020-04-01 |
| Micra Transcatheter Pacing System and Micra AV TPS (P150033/S069) | Medtronic, Inc. | 2020-04-01 |
| Pacemaker Devices - INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI (P150012/S088) | Boston Scientific | 2020-04-01 |
| Subcutaneous ICD Devices: EMBLEM S-ICD (P110042/S133) | Boston Scientific Corporation | 2020-04-01 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S024) | Boston Scientific Corp | 2020-04-01 |
| Impella RP System (P170011/S021) | Abiomed, Inc. | 2020-04-01 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella LD and Impella 5.5 with SmartAssist Systems (P140003/S068) | Abiomed, Inc. | 2020-04-01 |
| Pacemaker Devices - ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT, (INSIGNIA and ALTRUA 2 supported (N970003/S247) | Boston Scientific Corp | 2020-04-01 |
| Edwards SAPIEN 3 Transcatheter Heart Valves and Edwards SAPIEN 3 Ultra Transcatheter Heart Valves (P140031/S111) | Edwards Lifesciences, LLC | 2020-04-01 |
| PATHWAY Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody (P990081/S042) | Ventana Medical Systems, Inc. | 2020-03-31 |
| Visian Implantable Collamer Lens (P030016/S040) | STAAR Surgical Company | 2020-03-31 |
| VENTANA PD-L1(SP142) Assay (P160002/S011) | Ventana Medical Systems, Inc. | 2020-03-31 |
| VENTANA PD-L1 (SP263) Assay (P160046/S007) | Ventana Medical Systems, Inc. | 2020-03-31 |
| VENTANA ALK (D5F3) CDx Assay (P140025/S012) | Ventana Medical Systems, Inc. | 2020-03-31 |
| INFORM HER2 Dual ISH DNA Probe Cocktail (P100027/S032) | Ventana Medical Systems, Inc. | 2020-03-31 |
| Thermocool Smarttouch Bi-Directional Navigation Catheter, Thermocool Smarttouch SF Uni-Directional Navigation Catheter, (P040036/S071) | Biosense Webster, Inc. | 2020-03-31 |
| Gel-One (P080020/S037) | Seikagaku Corp. | 2020-03-31 |
| PATHWAY Anti-c-KIT (9.7) Primary Antibody (P020055/S022) | Ventana Medical Systems, Inc. | 2020-03-31 |
| Thermocool Smarttouch Bi-Directional Navigation Catheter, Thermocool Smarttouch SF Uni-Directional Navigation Catheter, (P030031/S103) | Biosense Webster, Inc. | 2020-03-31 |
| Collamer Intraocular Lens (P990013/S040) | Starr Surgical Co. | 2020-03-31 |
| Inoue Balloon Catheter (P910054/S007) | Toray Industries (America), Inc. | 2020-03-30 |
| Impella RP System (P170011/S022) | Abiomed, Inc. | 2020-03-30 |
| HeartMate 3 Left Ventricular Assist System (LVAS) (P160054/S027) | ABBOTT MEDICAL | 2020-03-30 |
| HeartWare Ventricular Assist System (P100047/S156) | Medtronic | 2020-03-30 |
| C-flex lntraocular Lens, C-flex Aspheric lntraocular Lens, 6.0 mm Aspheric lntraocular Lens, and RayOne Aspheric (P060011/S020) | Rayner Intraocular Lenses , Ltd. | 2020-03-30 |
| Obalon Balloon System (P160001/S046) | Medtimo, Inc. | 2020-03-30 |
| Inspire Stimulation and Sensing Leads (P130008/S050) | Inspire Medical Systems | 2020-03-30 |
| COBRA PzF NanoCoated Coronary Stent System (P160014/S010) | Celonova Biosciences, Inc. | 2020-03-29 |
| Activa Deep Brain Stimulation Therapy System (P960009/S370) | Medtronic, Inc. | 2020-03-27 |
| Veryan BioMimics 3D Vascular Stent System (P180003/S001) | Veryan Medical, Ltd. | 2020-03-27 |
| SpinalStim (P850007/S044) | Orthofix, Inc. | 2020-03-27 |
| Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Lea (P840001/S457) | Medtronic Neuromodulation | 2020-03-27 |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled (P130026/S057) | St Jude Medical | 2020-03-27 |
| LifeVest Wearable Defibrillator (P010030/S132) | Zoll Manufacturing Corporation | 2020-03-26 |
| enVista Hydrophobic Acrylic Intraocular Lens (IOL) (P910056/S039) | Bausch & Lomb, Inc. | 2020-03-26 |
| Reply SR and Reply DR Pacemakers (P950029/S125) | MicroPort CRM USA, Inc. | 2020-03-26 |
| VNS Therapy System (P970003/S232) | LivaNova USA, Inc. | 2020-03-26 |
| Tendril SDX, OptiSense, Tendril STS, and Tendril ST (P960013/S111) | ABBOTT MEDICAL | 2020-03-26 |
| Restylane® Kysse (P140029/S021) | Q-Med AB | 2020-03-26 |
| Durata, Optisure (P950022/S130) | ABBOTT MEDICAL | 2020-03-26 |
| Isoflex (P960030/S068) | ABBOTT MEDICAL | 2020-03-26 |
| Tendril MRI (P140033/S056) | ABBOTT MEDICAL | 2020-03-26 |
| Quickflex, Quartet (P030054/S377) | ABBOTT MEDICAL | 2020-03-26 |
| StarClose SE Vascular Closure System (P050007/S039) | Abbott Vascular Devices | 2020-03-25 |
| Prismaflex TPE2000 Set (P830063/S015) | Vantive US Healthcare, LLC | 2020-03-25 |
| WOLVERINE Coronary Cutting Balloon (P950020/S105) | Boston Scientific Corp | 2020-03-25 |
| KARL STORZ Photodynamic Diagnostic D-Light C System (P050027/S020) | KARL STORZ Endoscopy-America, Inc. | 2020-03-25 |
| Biofinity Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S103) | CooperVision, Inc. | 2020-03-24 |
| Medtronic Open Pivot Heart Valve, Medtronic Open Pivot Aortic Valved Graft (P990046/S057) | Medtronic Ats Medical, Inc. | 2020-03-24 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent Systems (P160043/S033) | Medtronic Vascular | 2020-03-24 |
| Resolute Integrity Zotarolimus-Eluting Coronary Stent Systems (P110013/S101) | Medtronic Vascular | 2020-03-24 |
| SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S334) | Medtronic, Inc. | 2020-03-23 |
| myChoice CDx (P190014/S002) | Myriad Genetic Laboratories, Inc. | 2020-03-23 |
| Alinity m HCV (P190025) | Abbott Molecular, Inc. | 2020-03-23 |
| IsoMed Infusion System (P990034/S039) | Medtronic, Inc. | 2020-03-23 |
| HeartWare Ventricular Assist System (P100047/S158) | Medtronic | 2020-03-20 |
| EMBLEM S-ICD System (P110042/S132) | Boston Scientific Corporation | 2020-03-20 |
| Guardian Connect System (P160007/S032) | Medtronic Minimed | 2020-03-20 |
| Activa Deep Brain Stimulation Therapy System (P960009/S369) | Medtronic, Inc. | 2020-03-20 |
| VNS Therapy System (P970003/S225) | LivaNova USA, Inc. | 2020-03-20 |
| NeuroPace RNS System (P100026/S079) | NeuroPace, Inc. | 2020-03-20 |
| Open Pivot Heart Valves and Open Pivot Aortic Valved Graft (P990046/S056) | Medtronic Ats Medical, Inc. | 2020-03-20 |
| InterStim Therapy System, Verify Evaluation System (SNS Urinary) (P970004/S308) | Medtronic Neuromodulation | 2020-03-20 |
| Medtronic CoreValve Evolut R System, Medtronic CoreValve Evolut PRO System (P130021/S073) | Medtronic, Inc. | 2020-03-20 |
| LUTONIX 035 Drug Coated Balloon PTA Catheter (P130024/S031) | Lutonix | 2020-03-20 |
| CentriMag Circulatory Support System (P170038/S001) | Abbott | 2020-03-20 |
| Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Lea (P840001/S456) | Medtronic Neuromodulation | 2020-03-20 |
| InterStim Therapy System, Verify Evaluation System (SNS Bowel) (P080025/S203) | Medtronic Neuromodulation | 2020-03-20 |
| MULTI-LINK 8, MULTI-LINK 8 SV/LL CORONARY STENT SYSTEMS (P020047/S072) | Abbott Vascular | 2020-03-19 |
| BD Onclarity HPV Assay (P160037/S006) | Becton, Dickinson and Company | 2020-03-19 |
| SURGIFOAM Absorbable Gelatin Sponge, U.S.P. (P990004/S037) | Ferrosan Meidcal Devices A/S | 2020-03-19 |
| Restylane Refyne, Restylane Defyne Injectable Gels (P140029/S024) | Q-Med AB | 2020-03-19 |
| XIENCE PRIME, XIENCE PRIME SV/LL, XIENCE Xpedition, XIENCE Xpedition SV/LL, XIENCE Alpine, and XIENCE Sierra EVEROLIMUS (P110019/S108) | Abbott Vascular | 2020-03-19 |
| ADVIA Centaur and Atellica IM HBeAg (P090024/S007) | Siemens Healthcare Diagnostics | 2020-03-19 |
| ADVIA Centaur HBsAg (P030049/S014) | Siemens Healthcare Diagnostics | 2020-03-19 |
| Gelfoam (absorbable gelatin) Sterile Sponge (N18286/S035) | Pfizer, Inc. | 2020-03-19 |
| ADVIA Centaur and Atellica IM HBc IgM (P030040/S016) | Siemens Healthcare Diagnostics | 2020-03-19 |
| ADVIA Centaur and Atellica IM PSA (P950021/S020) | Siemens Healthcare Diagnostics | 2020-03-19 |
| Attain Stability Quad MRI Lead (P080006/S145) | Medtronic, Inc. | 2020-03-19 |
| PD-L1 IHC 22C3 pharmDx (P150013/S017) | Agilent Technologies, Inc. | 2020-03-19 |
| Lotrafilcon A Soft Contact Lenses and Lotrafilcon B Soft Contact Lenses (P010019/S076) | Alcon Laboratories, Inc. | 2020-03-19 |
| ADVIA Centaur and Atellica IM AFP (P930036/S013) | Siemens Healthcare Diagnostics, Inc. | 2020-03-19 |