BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Permanent Defibrillator Electrodes

    PMA: P030036 · Supplement: S009 · Decision Feb 25, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36

    Basic Information

    Device Name
    Permanent Defibrillator Electrodes
    Trade Name
    SELECTSECURE LEAD
    PMA Number
    P030036
    Supplement Number
    S009
    Device Class
    FDA Class 3
    Product Code
    NVY
    Generic Name
    Permanent defibrillator electrodes
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 25, 2009
    Date Received
    August 22, 2008
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FOLLOWING CHANGES: 1) A CHANGE IN THE MANUFACTURING FACILITY FOR THE DRUG VIAL FILLING PROCESS; 2) THE ADDITION OF A CONTRACT LABORATORY FOR DRUG RELEASE TESTING; AND 3) A CHANGE IN A QUALITY CONTROL TEST USED TO DETERMINE A SPECIFIC ATTRIBUTE OF AN INCOMING RAW MATERIAL.

    Classifications

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

    Product Code Device Name
    NVY Permanent Defibrillator Electrodes