BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Dilator, Cervical, Synthetic, Osmotic, Pregnancy Termination

    PMA: P820075 · Supplement: S007 · Decision Jan 3, 1996
    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) OSMOSTIC CERVICAL DILATOR
    PMA Number
    P820075
    Supplement Number
    S007
    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
    January 3, 1996
    Date Received
    May 22, 1995
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR RELOCATING CABOT'S LAMICEL PROCESSING EQUIPMENT AND THE ASSOCIATED METHODS OR PROCEDURESTO THE MEROCEL FACILITY AT 950 FLANDERS ROAD, MYSTIC, CONNECTICUT, 06355

    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