BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Paste, Injectable For Vocal Cord Augmentation

    PMA: N16420 · Supplement: S005 · Decision May 30, 2001
    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 INJECTION
    PMA Number
    N16420
    Supplement Number
    S005
    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
    May 30, 2001
    Date Received
    December 26, 2000
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A MANUFACTURING SITE LOCATED AT MENTOR CORPORATION, MINNEAPOLIS, MN, AND APPROVAL FOR TWO STERILIZATION SITES LOCATED AT STERIS ISOMEDIX, INC., MINNEAPOLIS, MN, AND BIOTEST LABORATORIES, INC., MINNEAPOLIS, MN.

    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