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    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Laparoscopic Contraceptive Tubal Occlusion Device

    PMA: P070022 · Decision Jul 6, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7

    Basic Information

    Device Name
    Laparoscopic Contraceptive Tubal Occlusion Device
    Trade Name
    ADIANA PERMANENT CONTRACEPTION SYSTEM
    PMA Number
    P070022
    Device Class
    FDA Class 3
    Product Code
    KNH
    Generic Name
    Laparoscopic contraceptive tubal occlusion device
    Regulation Number
    884.5380
    Medical Specialty
    Obstetrics/Gynecology
    Advisory Committee
    Obstetrics/Gynecology
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    July 6, 2009
    Date Received
    August 10, 2007
    Expedited Review
    N
    Docket Number
    09M-0317

    Advisory Committee Statement

    APPROVAL FOR THE ADIANA PERMANENT CONTRACEPTION SYSTEM. THE DEVICE IS INDICATED FOR WOMEN WHO DESIRE PERMANENT BIRTH CONTROL (FEMALE STERILIZATION) BY OCCLUSION OF THE FALLOPIAN TUBES.

    Classifications

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

    Product Code Device Name
    KNH Laparoscopic Contraceptive Tubal Occlusion Device