BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Transcervical Contraceptive Tubal Occlusion Device

    PMA: P020014 · Supplement: S007 · Decision Apr 8, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Transcervical Contraceptive Tubal Occlusion Device
    Trade Name
    CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL
    PMA Number
    P020014
    Supplement Number
    S007
    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
    April 8, 2004
    Date Received
    March 24, 2004
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Express GMP Supplement
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A MANUFACTURING SITE LOCATED AT VENUSA, LTD., CHIHUAHUA, MEXICO.

    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