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

    Paste, Injectable For Vocal Cord Augmentation

    PMA: N16420 · Supplement: S007 · Decision Jan 3, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Paste, Injectable For Vocal Cord Augmentation
    Trade Name
    MENTOR POLYTEF PASTE FOR INJECTION
    PMA Number
    N16420
    Supplement Number
    S007
    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
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    January 3, 2005
    Date Received
    December 9, 2004
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE IN VENDOR OF A RAW MATERIAL FOR POLYTEF PASTE FOR INJECTION.

    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