BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Aortic Valve, Prosthesis, Percutaneously Delivered

    PMA: P130009 · Supplement: S034 · Decision Oct 9, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24

    Basic Information

    Device Name
    Aortic Valve, Prosthesis, Percutaneously Delivered
    Trade Name
    EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES
    PMA Number
    P130009
    Supplement Number
    S034
    Device Class
    FDA Class 3
    Product Code
    NPT
    Generic Name
    Aortic valve, prosthesis, percutaneously delivered
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 9, 2015
    Date Received
    April 15, 2015
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    15M-4017

    Advisory Committee Statement

    APPROVAL FOR THE SAPIEN XT TRANSCATHETER HEART VALVE, MODEL 9300TFX, AND ACCESSORIES. THIS DEVICE IS INDICATED FOR USE IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO EITHER SEVERE NATIVE CALCIFIC AORTIC STENOSIS OR FAILURE (STENOSED, INSUFFICIENT, OR COMBINED) OF A SURGICAL BIOPROSTHETIC AORTIC VALVE WHO ARE JUDGED BY A HEART TEAM, INCLUDING A CARDIAC SURGEON, TO BE AT HIGH OR GREATER RISK FOR OPEN SURGICAL THERAPY (I.E., SOCIETY OF THORACIC SURGEONS OPERATIVE RISK SCORE >8% OR AT A >15% RISK OF MORTALITY AT 30 DAYS).

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NPT Aortic Valve, Prosthesis, Percutaneously Delivered