BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Transcervical Contraceptive Tubal Occlusion Device

    PMA: P020014 · Supplement: S048 · Decision Dec 14, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Transcervical Contraceptive Tubal Occlusion Device
    Trade Name
    ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL
    PMA Number
    P020014
    Supplement Number
    S048
    Device Class
    FDA Class 3
    Product Code
    HHS
    Generic Name
    Transcervical contraceptive tubal occlusion device
    Regulation Number
    884.5380
    Medical Specialty
    Obstetrics/Gynecology
    Advisory Committee
    Obstetrics/Gynecology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    December 14, 2016
    Date Received
    November 21, 2016
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Establishment of a new site for manufacturing the delivery wire (component of the Essure delivery system) at 340 Lake Hazeltine Drive, Chaska, Minnesota.

    Classifications

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

    Product Code Device Name
    HHS Transcervical Contraceptive Tubal Occlusion Device