BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Cochlear

    PMA: P960058 · Supplement: S027 · Decision Nov 6, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Implant, Cochlear
    Trade Name
    CLARION CII BIONIC EAR SYSTEM (PEDIATRIC)
    PMA Number
    P960058
    Supplement Number
    S027
    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
    November 6, 2002
    Date Received
    October 25, 2002
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A REVISION TO THE PACKAGE INSERT (DOCUMENT NUMBER 9196252-001) THAT MODIFIED THE PERCENTAGE OF PATIENTS WHO PREFERRED HIGH RESOLUTION SOUND PROCESSING TO CONVENTIONAL SOUND PROCESSING. THIS MODIFICATION IS BASED ON UPDATED DATA RECEIVED FROM PATIENTS AT THE 12-MONTH FOLLOW-UP VISIT WHICH SHOWED THAT THREE OF THE FIVE PATIENTS WHO ORIGINALLY PREFERRED THEIR CONVENTIONAL STRATEGY AT THE THREE-MONTH EXPERIMENTAL STRATEGY VISIT SWITCHED THEIR PREFERENCE TO HIRES. THUS, 48 OF 50 PATIENTS (96%) ULTIMATELY PREFERRED HIRES.

    Classifications

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

    Product Code Device Name
    MCM Implant, Cochlear