BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pulse-Generator, Single Chamber, Single

    PMA: P860007 · Supplement: S018 · Decision Aug 19, 1996
    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
    S018
    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
    August 19, 1996
    Date Received
    March 8, 1996
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE USE OF AN ALTERNATE CONDUCTIVE EPOXY AND A PRODUCTION PROCESS CHANGE FOR AUTOMATED APPLICATION OF THIS EPOXY IN THE MANUFACTURE OF IMPLANTABLE PULSE GENERATORS

    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