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

    Dilator, Cervical, Synthetic, Osmotic, Pregnancy Termination

    PMA: P820075 · Supplement: S008 · Decision Jul 9, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    Dilator, Cervical, Synthetic, Osmotic, Pregnancy Termination
    Trade Name
    LAMICEL OSMOTIC CERVICAL DILATOR
    PMA Number
    P820075
    Supplement Number
    S008
    Device Class
    FDA Class 3
    Product Code
    LOB
    Generic Name
    dilator, cervical, synthetic, osmotic, pregnancy termination
    Medical Specialty
    Unknown
    Advisory Committee
    Obstetrics/Gynecology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    July 9, 1999
    Date Received
    June 24, 1999
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    The 30-Day Notice requested a change in the approved sterilization process of e-beam to gamma radiation process.

    Classifications

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

    Product Code Device Name
    LOB Dilator, Cervical, Synthetic, Osmotic, Pregnancy Termination