BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pulse-Generator, Single Chamber, Single

    PMA: P860007 · Supplement: S020 · Decision Jul 6, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Pulse-Generator, Single Chamber, Single
    Trade Name
    INTERTACH II MODELS 262-16
    PMA Number
    P860007
    Supplement Number
    S020
    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
    July 6, 1998
    Date Received
    May 19, 1998
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for alternate Polyethylene Terephthalate Glycol (PETG) packaging material for the Intetach II, Model 262-16 pulse generator.

    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