BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    PMA: P010015 · Supplement: S430 · Decision May 17, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Implantable Pulse Generator, Pacemaker (Non-Crt)
    Trade Name
    CaareLink SmartSync Percepta Serena Solara Application, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipol
    PMA Number
    P010015
    Supplement Number
    S430
    Device Class
    FDA Class 3
    Product Code
    LWP
    Generic Name
    Implantable pulse generator, pacemaker (non-CRT)
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 17, 2020
    Date Received
    February 28, 2020
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for CareLink SmartSync Common Application version 3.2.01, CareLink SmartSync Azure Astra Application version 3.2.02, CareLink SmartSync Percepta Serena Solara Application version 3.2.02.

    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)