BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Transurethral Occlusion Insert, Urinary Incontinence-Control, Female

    PMA: P990002 · Supplement: S002 · Decision Mar 21, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Transurethral Occlusion Insert, Urinary Incontinence-Control, Female
    Trade Name
    FEMSOFT URETHRAL INSERT
    PMA Number
    P990002
    Supplement Number
    S002
    Device Class
    FDA Class 3
    Product Code
    OCK
    Generic Name
    Transurethral occlusion insert, urinary incontinence-control, female
    Medical Specialty
    Unknown
    Advisory Committee
    Gastroenterology, Urology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 21, 2013
    Date Received
    December 26, 2012
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR LABELING MODIFICATIONS.

    Classifications

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

    Product Code Device Name
    OCK Transurethral Occlusion Insert, Urinary Incontinence-Control, Female