BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pulse Generator, Permanent, Implantable

    PMA: P910023 · Supplement: S098 · Decision Apr 5, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Pulse Generator, Permanent, Implantable
    Trade Name
    SJM ICD'S PHOTON MICRO, EPIC, EPIC +, ATLAS, ATLAS + (ICDS)
    PMA Number
    P910023
    Supplement Number
    S098
    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
    April 5, 2006
    Date Received
    February 2, 2006
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MINOR MODIFICATIONS TO THE DESIGN OF THE HIGH VOLTAGE CAPACITOR, BATTERY, FEEDTHRUS/HEADERS AND DISCRETE COMPONENTS. SPECIFICALLY, ALTERATION OF THE BATTERY PIN CONFIGURATION, MODIFICATION OF THE FEEDTHRU WIRE TUBING LENGTHS AND OF THE METHOD USED FOR APPLYING INSULATION, CHANGE IN THE VALUE OF C36 CAPACITOR FROM 10NF TO 680PF, QUALIFICATION OF AN ALTERNATE ACCELEROMETER SUBSTRATE WITH INTEGRATED RESISTOR CAPACITOR, AND THE SHIFTING OF THE ANCHOR BRIDGE TO FEEDTHRU FLANGE FROM 0.17" TO 0.18".

    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