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

    Pulse Generator, Permanent, Implantable

    PMA: P980035 · Supplement: S821 · Decision Sep 5, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Research PMA P980035 in seconds

    The Research Assistant summarizes PMA approval history, supplements and related safety signals — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    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); Az
    PMA Number
    P980035
    Supplement Number
    S821
    Device Class
    FDA Class 3
    Product Code
    NVZ
    Generic Name
    Pulse generator, permanent, implantable
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    September 5, 2025
    Date Received
    August 18, 2025
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    implementation of a new visual inspection procedure

    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