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

    Pulse Generator, Permanent, Implantable

    PMA: P980035 · Supplement: S522 · Decision Oct 31, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Pulse Generator, Permanent, Implantable
    Trade Name
    Attesta DR MRI SureScan, L DR MRI SureScan, S DR MRI SureScan, SR MRI SureScan, Sphera DR MRI SureScan, L DR MRI SureSca
    PMA Number
    P980035
    Supplement Number
    S522
    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
    October 31, 2017
    Date Received
    October 6, 2017
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Implementation of the following previously accepted changes: modifications to heavy metal testing for silicone, additional vision system for inspection of final packaged devices, additional laser welder for use in manufacturing of the battery header subassembly, a change to the chemical used for the etch process for integrated circuit components, an update to the hybrid testing process, changes to the integrated circuit tests used for pacemaker devices, and an update to the software used in the final functional device tester.

    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