BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pulse Generator, Permanent, Implantable

    PMA: P890003 · Supplement: S242 · Decision Dec 21, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Pulse Generator, Permanent, Implantable
    Trade Name
    CARELINK PROGRAMMER CRM PROGRAMMER
    PMA Number
    P890003
    Supplement Number
    S242
    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
    December 21, 2011
    Date Received
    November 25, 2011
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR COMPONENTS CHANGING FROM LEAD-CONTAINING TO LEAD-FREE USED IN THE MEDTRONIC 2090 PROGRAMMER, 5388 DUAL CHAMBER EPG, AND 5348 SINGLE CHAMBER EPG.

    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