BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pulse-Generator, Single Chamber, Single

    PMA: P860007 · Supplement: S021 · Decision Dec 2, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Pulse-Generator, Single Chamber, Single
    Trade Name
    IMPLANTABLE PACEMAKER LEADS
    PMA Number
    P860007
    Supplement Number
    S021
    Device Class
    FDA Class 3
    Product Code
    LWW
    Generic Name
    PULSE-GENERATOR, SINGLE CHAMBER, SINGLE
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 2, 1999
    Date Received
    October 25, 1999
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Express GMP Supplement
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the manufacturing and labeling facility located at Guidant Corp., St. Paul, MN 55112-5798.

    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