BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Dilator, Cervical, Synthetic, Osmotic, Pregnancy Termination

    PMA: P820075 · Supplement: S006 · Decision Oct 10, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    Dilator, Cervical, Synthetic, Osmotic, Pregnancy Termination
    Trade Name
    LAMICEL(R) OSSMOTIC CERVICAL DILATOR
    PMA Number
    P820075
    Supplement Number
    S006
    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
    Decision Code
    APPR
    Decision Date
    October 10, 1995
    Date Received
    May 12, 1995
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR NEW ACCELERATED TESTING PROTOCOL TO ESTABLISH THE SHELF-LIFE OF YOUR PRODUCT TO 24 MONTHS

    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