BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Device, Hemostasis, Vascular

    PMA: P990037 · Supplement: S013 · Decision Feb 21, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33

    Basic Information

    Device Name
    Device, Hemostasis, Vascular
    Trade Name
    DUETT SEALING DEVICE
    PMA Number
    P990037
    Supplement Number
    S013
    Device Class
    FDA Class 3
    Product Code
    MGB
    Generic Name
    Device, hemostasis, vascular
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    February 21, 2003
    Date Received
    January 23, 2003
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE IN THE MANUFACTURING PROCEDURES TO PROPOSE REDUCTION IN POUCH AND SEAL STRENGTH TOLERANCE, TOLERANCE CHANGE TO THE KNOB BASE AND HUB BASE, CHANGES TO THE SEALING ACHANGE IN THE MANUFACTURING PROCEDURES TO PROPOSE REDUCTION IN POUCH AND SEAL STRENGTH TOLERANCE, TOLERANCE CHANGE TO THE KNOB BASE AND HUB BASE, CHANGES TO THE SEALING AND PILOT BALLOONS, SLEEVE MARKING CHANGES AND REDUCTION IN THE BIOBURDEN MONITORING LIMITS FOR THE DUETT FAMILY OF SEALING DEVICES.ND PILOT BALLOONS, SLEEVE MARKING CHANGES AND REDUCTION IN THE BIOBURDEN MONITORING LIMITS FOR THE DUETT FAMILY OF SEALING DEVICES.

    Classifications

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

    Product Code Device Name
    MGB Device, Hemostasis, Vascular