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

    Pulse Generator, Permanent, Implantable

    PMA: P980035 · Supplement: S499 · Decision Jun 4, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Pulse Generator, Permanent, Implantable
    Trade Name
    Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG
    PMA Number
    P980035
    Supplement Number
    S499
    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
    June 4, 2017
    Date Received
    May 10, 2017
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    1) New supplier for material used in battery manufacturing; implementation of an update to FACTORYworks (FW) Release 9.3.; 2) updated test equipment for use in battery manufacturing; 3) changes to the acceptance parameter specification limits for certain wafers and associated process changes; 4) the addition of mixing equipment used in battery manufacturing; 5) an additional laser welder for use in battery manufacturing; and 6) changes to the manufacturing process flow at an integrated circuit component supplier as well as the addition of visual inspection requirements.

    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