BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Dilator, Cervical, Synthetic, Osmotic, Pregnancy Termination

    PMA: P840045 · Supplement: S006 · Decision Oct 25, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    Dilator, Cervical, Synthetic, Osmotic, Pregnancy Termination
    Trade Name
    DILAPAN-S
    PMA Number
    P840045
    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 25, 2002
    Date Received
    March 31, 2000
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A NEW DEVICE DESIGN AND NEW MANUFACTURING LOCATION. THE DEVICE, AS MODIFIED AND WITH REVISED LABELING, WILL BE MARKETED UNDER THE TRADE NAME DILAPAN-S AND IS INDICATED FOR DILATATION OF THE CERVIX UTERI PRIOR TO TERMINATION OF PREGNANCY UP TO 16 WEEKS GESTATION. A SINGLE DILAPAN-S IS INSERTED INTO THE ENDOCERVICAL CANAL AND MAY REMAIN IN SITU FOR UP TO FOUR HOURS. THE DEVICE WILL BE MANUFACTURED AT A NEW FACILITY LOCATED AT GELMED INTERNATIONAL, IN THE CZECH REPUBLIC AND STERILIZED AT A CONTRACT STERILIZATION FACILITY LOCATED AT BIOSTER A.S., IN THE CZECH REPUBLIC.

    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