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

    Permanent Pacemaker Electrode

    PMA: P960030 · Supplement: S004 · Decision Oct 8, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24

    Basic Information

    Device Name
    Permanent Pacemaker Electrode
    Trade Name
    PASSIVE PLUS DX STEROID ELUTING, ENDOCARDIAL PACING LEADS
    PMA Number
    P960030
    Supplement Number
    S004
    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
    October 8, 1998
    Date Received
    September 16, 1998
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    The 30-day Notice requested that FDA review a change in material from ETR and MDX silicone rubber to liquid silicone rubber, and a change in the manufacturing process, from transfer molding to liquid injection molding, using an approved vendor. These changes apply to the fins, tines, and suture sleeve components of the Passive Plus(R) Endocardial Pacing Leads.

    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