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

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    PMA: P010015 · Supplement: S051 · Decision Sep 10, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Implantable Pulse Generator, Pacemaker (Non-Crt)
    Trade Name
    INSYNC PULSE GENERATOR; INSYNC III
    PMA Number
    P010015
    Supplement Number
    S051
    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
    September 10, 2008
    Date Received
    August 11, 2008
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    ADDITION FO AN ETO STERILIZER AT THE TOLOCHENAZ, SWITZERLAND FACILITY AND CHANGES TO THE ETHYLENE OXIDE STERILIZATION LETHALITY MODEL. THE ADDITION OF THE ETO STERILIZER IS NOT APPLICABLE TO THE FOLLOWING DEVICES: CONSULTA, MAXIMO II, SECURA DR/VR FAMILY, AND MAXIMO II DDR/VR FAMILY.

    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)