BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Ventricular (Assist) Bypass

    PMA: P870072 · Supplement: S006 · Decision Jan 21, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21

    Basic Information

    Device Name
    Ventricular (Assist) Bypass
    Trade Name
    THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM
    PMA Number
    P870072
    Supplement Number
    S006
    Device Class
    FDA Class 3
    Product Code
    DSQ
    Generic Name
    Ventricular (assist) bypass
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 21, 1998
    Date Received
    December 22, 1997
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N
    Docket Number
    N

    Advisory Committee Statement

    Approval for 1) changing the thread sealant/thread locking material for the stinless steel pneumatic driveline fitting to the polysulfone VAD case cap from room temperature vulcanizing (RTV) silicone to Master Bond Polymer System EP21LV, and 2) replacing the current two-piece welded hand pump bulb witha single-piece molded bulb.

    Classifications

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

    Product Code Device Name
    DSQ Ventricular (Assist) Bypass