BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Transcervical Contraceptive Tubal Occlusion Device

    PMA: P020014 · Supplement: S013 · Decision Sep 19, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Transcervical Contraceptive Tubal Occlusion Device
    Trade Name
    ESSURE PERMANENT BIRTH CONTROL SYSTEM
    PMA Number
    P020014
    Supplement Number
    S013
    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
    Approved
    Decision Code
    APPR
    Decision Date
    September 19, 2006
    Date Received
    July 17, 2006
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGES TO THE PATIENT INFORMATION BOOKLET.

    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