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

    Permanent Pacemaker Electrode

    PMA: P960004 · Supplement: S022 · Decision Jul 2, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24

    Basic Information

    Device Name
    Permanent Pacemaker Electrode
    Trade Name
    THINLINE II STEROX /FINELINE II STEROX ENDOCARDIAL PACING LEADS
    PMA Number
    P960004
    Supplement Number
    S022
    Device Class
    FDA Class 3
    Product Code
    DTB
    Generic Name
    permanent pacemaker Electrode
    Regulation Number
    870.3680
    Medical Specialty
    Cardiovascular
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    July 2, 2003
    Date Received
    June 3, 2003
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    ADDITION OF A BIOCOMPATIBLE ADHESIVE TO THE LEAD WHICH WILL ENHANCE THE ABILITY TO MAINTAIN THE POSITION OF THE DRUG-ELUTING COLLAR AT ITS DESIGNED LOCATION.

    Classifications

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

    Product Code Device Name
    DTB Permanent Pacemaker Electrode