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

    Pulse-Generator, Single Chamber, Single

    PMA: P860007 · Supplement: S023 · Decision Dec 22, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Pulse-Generator, Single Chamber, Single
    Trade Name
    INTERTACH
    PMA Number
    P860007
    Supplement Number
    S023
    Device Class
    FDA Class 3
    Product Code
    LWW
    Generic Name
    PULSE-GENERATOR, SINGLE CHAMBER, SINGLE
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    December 22, 2004
    Date Received
    December 3, 2004
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    USE OF A NEW BIOLOGICAL INDICATOR FOR THE STERILIZATION PROCESS.

    Classifications

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

    Product Code Device Name
    LWW Pulse-Generator, Single Chamber, Single