BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pulse Generator, Permanent, Implantable

    PMA: P980035 · Supplement: S374 · Decision Mar 19, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Pulse Generator, Permanent, Implantable
    Trade Name
    ADVISA SR MRI A3SR01; IMPLANTABLE PULSE GENERATOR, DR MRI A2DR01 IMPLANTABLE PULSE GENERATOR, SOFTWARE MODEL 9995
    PMA Number
    P980035
    Supplement Number
    S374
    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
    March 19, 2015
    Date Received
    April 23, 2014
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADVISA SR MRI A3SR01 IMPLANTABLE PULSE GENERATOR IN COMBINATION WITH THE CAPSUREFIX MRI SURESCAN LEAD MODEL 5086MRI TO BE MARKETED AS THE ADVISA SR MRI SURESCAN. IN ADDITION YOU REQUESTED APPROVAL FOR MODIFICATIONS TO THE ADVISA SR MRI AND ADVISA DR MRI SOFTWARE APPLICATION MODEL 9995.

    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