BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Dilator, Cervical, Synthetic, Osmotic, Pregnancy Termination

    PMA: P820075 · Decision Jun 21, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    Dilator, Cervical, Synthetic, Osmotic, Pregnancy Termination
    Trade Name
    LAMICEL(TM)
    PMA Number
    P820075
    Device Class
    FDA Class 3
    Product Code
    LOB
    Generic Name
    dilator, cervical, synthetic, osmotic, pregnancy termination
    Medical Specialty
    Unknown
    Advisory Committee
    Obstetrics/Gynecology
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    June 21, 1983
    Date Received
    October 7, 1982
    Expedited Review
    N
    Docket Number
    83M-0216

    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