BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Paste, Injectable For Vocal Cord Augmentation

    PMA: N16420 · Supplement: S004 · Decision Dec 8, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Paste, Injectable For Vocal Cord Augmentation
    Trade Name
    POLYTEF PASTE FOR VOCAL CORD INJECTION
    PMA Number
    N16420
    Supplement Number
    S004
    Device Class
    FDA Class 3
    Product Code
    LTG
    Generic Name
    PASTE, INJECTABLE FOR VOCAL CORD AUGMENTATION
    Medical Specialty
    Unknown
    Advisory Committee
    Ear, Nose, Throat
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 8, 1993
    Date Received
    December 24, 1992
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Classifications

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

    Product Code Device Name
    LTG Paste, Injectable For Vocal Cord Augmentation