BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Transurethral Occlusion Insert, Urinary Incontinence-Control, Female

    PMA: P960020 · Supplement: S001 · Decision Apr 1, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Transurethral Occlusion Insert, Urinary Incontinence-Control, Female
    Trade Name
    RELIANCE URINARY CONTROL INSERT & SIZING DEVICE
    PMA Number
    P960020
    Supplement Number
    S001
    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
    April 1, 1999
    Date Received
    March 17, 1999
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    Approval for suspension of postapproval study because company is discontinuing manufacture and distribution of device.

    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