BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Transurethral Occlusion Insert, Urinary Incontinence-Control, Female

    PMA: P990002 · Supplement: S001 · Decision Dec 28, 2000
    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
    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
    December 28, 2000
    Date Received
    December 14, 2000
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO ADD THE PRECAUTION "AVOID HEAT" TO THE LABELING. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME FEMSOFT(R) INSERT AND IS INDICATED FOR THE MANAGEMENT OF STRESS URINARY INCONTINENCE IN ADULT FEMALES.

    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