BEUDAMED
    FDA PMA FDA Class 3 🇺🇸 United States

    Implant, Cochlear

    PMA: P940022 · Decision Mar 22, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Implant, Cochlear
    Trade Name
    CLARION(TM) MULTI-STRATEGY COCHLEAR IMPLANT
    PMA Number
    P940022
    Device Class
    FDA Class 3
    Product Code
    MCM
    Generic Name
    Implant, cochlear
    Medical Specialty
    Unknown
    Advisory Committee
    Ear, Nose, Throat
    Decision Code
    APCB
    Decision Date
    March 22, 1996
    Date Received
    June 30, 1994
    Expedited Review
    N
    Docket Number
    96M-0490

    Advisory Committee Statement

    APPROVAL FOR THE CLARION MULTI-STRATEGY COCHLEAR IMPLANT FOR USE IN AN ADULT POPLUATION

    Classifications

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

    Product Code Device Name
    MCM Implant, Cochlear