BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    PMA: P010015 · Supplement: S317 · Decision May 6, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Implantable Pulse Generator, Pacemaker (Non-Crt)
    Trade Name
    PERCEPTA QUAD CRT-P MRI SURESCAN, SERENA QUAD CRT-P MRI SURESCAN, SOLARA QUAD CRT-P MRI SURESCAN, IMPLANTABLE PULSE GENE
    PMA Number
    P010015
    Supplement Number
    S317
    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 6, 2017
    Date Received
    December 6, 2016
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the Percepta/Percepta Quad, Serena/Serena Quad and Solara/Solara Quad CRT-P MRI SureScan Implantable Pulse Generators with Cardiac Resynchronization Therapy.

    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)