BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Cochlear

    PMA: P960058 · Supplement: S037 · Decision Jul 23, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Implant, Cochlear
    Trade Name
    HIRESOLUTION BIONIC EAR SYSTEM
    PMA Number
    P960058
    Supplement Number
    S037
    Device Class
    FDA Class 3
    Product Code
    MCM
    Generic Name
    Implant, cochlear
    Medical Specialty
    Unknown
    Advisory Committee
    Ear, Nose, Throat
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 23, 2004
    Date Received
    May 10, 2004
    Supplement Type
    Special (Immediate Track)
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR EXPANSION OF THE IN-PROCESS INSPECTION PROCEDURE FOR THE HIRES 90K IMPLANT. NAMELY, THE PMA SUPPLEMENT PROPOSED TO ADD AN ADDITIONAL VISUAL INSPECTION STEP TO ENSURE WELD INTEGRITY BY USING A MINIMUM OF 80X MAGNIFICATION TO VERIFY THE FOLLOWING: 1) COMPLETE CLOSURE OF THE WELD HOLD, 2) ACCEPTABLE WELD QUALITY, AND 3) ABSENCE OF FOREIGN MATERIAL AT THE WELD SITE.

    Classifications

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

    Product Code Device Name
    MCM Implant, Cochlear