BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pulse Generator, Permanent, Implantable

    PMA: P980035 · Supplement: S836 · Decision May 14, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

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    Basic Information

    Device Name
    Pulse Generator, Permanent, Implantable
    Trade Name
    Astra S DR MRI IPG (X3DR01);Astra S SR MRI IPG (X3SR01);Astra XT DR MRI IPG (X1DR01); Astra XT SR MRI IPG (X1SR01); Azur
    PMA Number
    P980035
    Supplement Number
    S836
    Device Class
    FDA Class 3
    Product Code
    NVZ
    Generic Name
    Pulse generator, permanent, implantable
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 14, 2026
    Date Received
    February 13, 2026
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for updates to the protection diode component and associated manufacturing changes for cardiac resynchronization therapy pacemakers (CRT-Ps) and implantable pulse generators (IPGs).

    Classifications

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

    Product Code Device Name
    NVZ Pulse Generator, Permanent, Implantable