BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

    PMA: P080006 · Supplement: S078 · Decision Apr 28, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode
    Trade Name
    ATTAIN PERFORMA
    PMA Number
    P080006
    Supplement Number
    S078
    Device Class
    FDA Class 3
    Product Code
    OJX
    Generic Name
    Drug eluting permanent left ventricular (lv) pacemaker electrode
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    April 28, 2015
    Date Received
    April 3, 2015
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    THE FOLLOWING MANUFACTURING CHANGES:1) THE ADDITION OF AN ALTERNATIVE TESTING SYSTEM FOR ELECTRODE COMPONENTS; 2) USE OF FACTORYWORKS RELEASE 7.9 MANUFACTURING SOFTWARE; 3) A REDUCTION IN THE EXPOSURE TIME DURING ETHYLENE OXIDE HALF-CYCLE TESTING; 4) A REDUCTION IN THE FREQUENCY OF ENVIRONMENTAL MONITORING TESTING IN SPECIFICMANUFACTURING AREAS; 5) AN UPDATE TO THE MAXIMUM STERILIZATION LOAD PROFILE TEMPERATURE; AND 6) USE OF FACTORYWORKS RELEASE 7.11 MANUFACTURING SOFTWARE.

    Classifications

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

    Product Code Device Name
    OJX Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode