BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

    PMA: P060027 · Supplement: S107 · Decision Jul 23, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
    Trade Name
    Platinium CRT-D 1711; Platinium CRT-D 1741; Platinium 4LV CRT-D 1744; ENERGYA CRT-D 3711; ENERGYA CRT-D 3741; ENERGYA 4L
    PMA Number
    P060027
    Supplement Number
    S107
    Device Class
    FDA Class 3
    Product Code
    NIK
    Generic Name
    Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 23, 2025
    Date Received
    April 18, 2025
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the addition of Mylar spacers to our ALIZEA/CELEA pacemakers, allow hybrid tab replacements to occur at Microport’s Saluggia, Italy facility, and changes in manufacturing processes of other MicroPort’s pacemaker, ICD, and CRT-D systems.

    Classifications

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

    Product Code Device Name
    NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)