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

    Permanent Pacemaker Electrode

    PMA: P960006 · Supplement: S007 · Decision Dec 13, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24

    Basic Information

    Device Name
    Permanent Pacemaker Electrode
    Trade Name
    SWEETIP RX/SWEET PICOTIP RX/FLEXTEND
    PMA Number
    P960006
    Supplement Number
    S007
    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
    December 13, 2002
    Date Received
    November 13, 2002
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE IN THE MANUFACTURING PROCESS TO THE PARAMETRIC RELEASE METHOD, WHICH INVOLVES STERILE PRODUCT RELEASE BASED ON CONFORMANCE TO PRE-DEFINED STERILIZATION PARAMETERS RATHER THAN A RELEASE BASED ON DEMONSTRATING NO GROWTH IN BIOLOGICAL INDICATOR.

    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