PMA records

PMA, Device, Applicant table
PMADeviceApplicantDecision date
P980044S067SUPARTZ FXSeikagaku Corp.2026-09-04
P960058S177HiResolution Bionic Ear SystemAdvanced Bionics2026-09-04
P230030S024FARASTAR™ Pulsed Field Ablation (PFA) Generator; FARASTAR™ Mapping System Module (MSM); FARASTAR™ Recording System ModulFarapulse, Inc.2026-09-04
P230011S008TruSight Oncology ComprehensiveIllumina, Inc.2026-09-04
P220013S028TactiFlex™ Duo Ablation Catheter, Sensor Enabled™ (A-TFDM-D, A-TFDM-F, A-TFDM-J, A-TFDM-DD, A-TFDM-DF, A-TFDM-FF, A-TFDMABBOTT MEDICAL2026-09-04
P200010S024Guardant360® CDxGuardant Health, Inc.2026-09-04
P080020S056Gel-OneSeikagaku Corp.2026-09-04
P070026S129CERAMAX CERAMIC HIP SYSTEMDePuy Orthopaedics, Inc.2026-09-04
N16837S039Artegraft Collagen Vascular GraftLeMaitre Vascular, Inc.2026-09-04
P910056S063enVista hydrophobic acrylic intraocular lensBausch & Lomb, Inc.2026-09-03
P830055S374LCS(R) TOTAL KNEE SYSTEM, specifically ATTUNE™ Cruciate Retaining (CR), Posterior Stabilized (PS) and Revision Femoral CDepuy, Inc.2026-09-03
P250003S009Embrace Hydrogel Embolic SystemInstylla, Inc.2026-09-03
P240005S007enVista Envy™ hydrophobic acrylic intraocular lens (IOL)Bausch & Lomb, Inc.2026-09-03
P170012S032HEMOBLAST™ BellowsDilon Technologies, Inc.2026-09-03
P160055S056RxSight Light Adjustable Lens and Light Delivery DeviceRxsight, Inc.2026-09-03
P060022S038Akreos posterior chamber intraocular lensBausch & Lomb, Inc.2026-09-03
P040042S060Therapy™ Dual-8™ Ablation CatheterIrvine Biomedical,Inc.(Ibi)2026-09-03
P040014S052Therapy™ (including Bi-Directional and 4mm Thermistor) Ablation CatheterIrvine Biomedical, Inc.2026-09-03
P230003S019Alinity m HR HPVAbbott Molecular, Inc.2026-09-02
P210011S002xT CDxTempus AI, Inc.2026-09-02
P170038S032CentriMag™ Circulatory Support SystemAbbott2026-09-02
P160026S069LIFEPAK® 35 monitor/defibrillatorPhysio-Control, Inc.2026-09-02
P080011S204BIOFINITY (COMFILCON A)CooperVision, Inc.2026-09-02
P040045S145VISTAKON (SENOFILCON A) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKERVistakon, Division of Johnson & Johnson Vision Car2026-09-02
P030031S142THERMOCOOL SMARTTOUCH® SF CatheterBiosense Webster, Inc.2026-09-02
P010029S043EUFLEXXA® (1% sodium hyaluronate)Ferring Pharmaceuticals, Inc.2026-09-02
P160035S058EXCOR Pediatric Ventricular Assist DeviceBerlin Heart, Inc.2026-09-01
P160030S058Freestyle Libre Flash Glucose Monitoring SystemAbbott Diabetes Care, Inc.2026-09-01
P150021S061Freestyle Libre Pro Flash Glucose Monitoring SystemAbbott Diabetes Care, Inc.2026-09-01
P010014S118Oxford Partial Knee Anatomic Vivacit-E Meniscal BearingsBiomet Manufacturing Corp2026-09-01
P250016S004Belotero® Intense (+) LidocaineMerz North America, Inc.2026-08-31
P240042S004Tendyne Transcatheter Mitral Valve SystemABBOTT MEDICAL2026-08-31
P240027S006SpineSeal Spine SealantPramand, LLC2026-08-31
P240015S002Womed LeafWomed Sas2026-08-31
P170002S059RHA 2, RHA 3, RHA 4Teoxane S.A.2026-08-31
P230035S010AGENT Paclitaxel-Coated Balloon CatheterBoston Scientific Corporation2026-08-28
P200049S021Amplatzer™ Amulet™ Left Atrial Appendage OccluderABBOTT MEDICAL2026-08-28
P170024S027Surpass Elite™ Flow DiverterStryker Neurovascular2026-08-28
P170002S058RHA 2, RHA 3, RHA 4Teoxane S.A.2026-08-28
P160026S072Physio-Control LIFEPAK®35 monitor/defibrillatorPhysio-Control, Inc.2026-08-28