FDA.reportPublic FDA data

PMA records

PMA, Device, Applicant table
PMADeviceApplicantDecision date
P970004S455InterStim™ Therapy System, Verify™ Evaluation SystemMedtronic Neuromodulation2026-08-08
P960009S540Activa™ Deep Brain Stimulation Therapy System; Percept™ PC BrainSense™Medtronic, Inc.2026-08-08
P860004S459SynchroMed™ Infusion System; Ascenda™ Intrathecal CathetersMedtronic, Inc.2026-08-08
P840001S630Master Restore™; Itrel™; Synergy™; Intellis™; Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems and Pisces™; Specify™Medtronic Neuromodulation2026-08-08
P960016S094Ampere GeneratorSt Jude Medical2026-08-07
P240042S003Tendyne™ Transcatheter Mitral Valve SystemABBOTT MEDICAL2026-08-07
P220013S033TactiSys Quartz Equipment; Ampere GeneratorABBOTT MEDICAL2026-08-07
P210036S009PerClot® Polysaccharide Hemostatic SystemBaxter Healthcare Corporation2026-08-07
P210036S008PerClot® Polysaccharide Hemostatic SystemBaxter Healthcare Corporation2026-08-07
P200035S041OrganOx metra SystemOrganox Limited2026-08-07
P200010S032Guardant360® CDxGuardant Health, Inc.2026-08-07
P190006S113Axonics Sacral Neuromodulation SystemBoston Scientific Corporation2026-08-07
P180046S113Axonics Sacral Neuromodulation SystemBoston Scientific Corporation2026-08-07
P170030S065ORSIRO Sirolimus Eluting Coronary Stent SystemBiotronik AG2026-08-07
P130026S102TactiSys Quartz Equipment; Ampere GeneratorSt Jude Medical2026-08-07
P110016S095Ampere GeneratorABBOTT MEDICAL2026-08-07
P060019S059Ampere GeneratorIrvine Biomedical, Inc.2026-08-07
P040042S059Ampere GeneratorIrvine Biomedical,Inc.(Ibi)2026-08-07
P040014S051Ampere GeneratorIrvine Biomedical, Inc.2026-08-07
P020012S051SANAE®Tiger Aesthetics Medical, LLC2026-08-07
P240013S030Sphere-9 Catheter AFR-00001Medtronic, Inc.2026-08-06
P230030S018FARAPULSE™ Pulsed Field Ablation SystemFarapulse, Inc.2026-08-06
P180011S069Eluvia™ Drug-Eluting Vascular Stent SystemBoston Scientific Corp2026-08-06
P170008S064EluNIR™ Ridaforolimus Eluting Coronary Stent SystemMedinol, Ltd.2026-08-06
P160026S071LIFEPAK® 35 monitor/defibrillatorPhysio-Control, Inc.2026-08-06
P140028S087Innova™ Self Expanding Stent SystemBoston Scientific Corporation2026-08-06
P110035S078Epic™ Vascular Self-Expanding Stent SystemBoston Scientific Corp2026-08-06
P100016S026CT LUCIA 602; CT LUCIA 202; CT LUCIA 611P; CT LUCIA 621PCarl Zeiss Meditec Production, LLC2026-08-06
P100010S152Stop AF FirstMedtronic Cryocath, LP2026-08-06
P830055S360ATTUNE Revision Knee SystemDepuy, Inc.2026-08-05
P250016S001Belotero® Intense (+) LidocaineMerz North America, Inc.2026-08-05
P230013S032Edwards EVOQUE Tricuspid Valve Replacement SystemEdwards Lifesciences, LLC2026-08-05
P220015DilightTM (roflufocon E) Overnight Orthokeratology Contact LensTianjin MasterVision Technology Co., Ltd.2026-08-05
P220014S012CraniSeal Dural SealantPramand, LLC2026-08-05
P160035S059EXCOR Pediatric Ventricular Assist DeviceBerlin Heart, Inc.2026-08-05
P160017S139MiniMed 770G Insulin Pump; MiniMed 780G Insulin PumpMedtronic Minimed, Inc.2026-08-05
P100047S240HeartWare™ HVAD™ SystemMedtronic2026-08-05
P030036S161SelectSecure Lead 3830Medtronic Cardiac Rhythm Disease Management2026-08-05
P030004S042Onyx™ Liquid Embolic System (LES)Ev3 Neurovascular2026-08-05
P930038S107Angio Seal VIP Vascular Closure DeviceTerumo Medical Corporation2026-08-04