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

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    PMA: P960040 · Supplement: S055 · Decision Jun 14, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Implantable Pulse Generator, Pacemaker (Non-Crt)
    Trade Name
    VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
    PMA Number
    P960040
    Supplement Number
    S055
    Device Class
    FDA Class 3
    Product Code
    LWP
    Generic Name
    Implantable pulse generator, pacemaker (non-CRT)
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    June 14, 2005
    Date Received
    May 26, 2005
    Supplement Type
    30-Day Notice
    Expedited Review
    N

    Advisory Committee Statement

    USE OF AN ALTERNATE EPOXY IN THE MANUFACTURE OF POWER MODULES FOR THE VITALITY FAMILY OF ICDS AND THE CONTAK RENEWAL FAMILY OF CRT-D DEVICES.

    Classifications

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

    Product Code Device Name
    LWP Implantable Pulse Generator, Pacemaker (Non-Crt)