BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pulse Generator, Permanent, Implantable

    PMA: P890003 · Supplement: S260 · Decision Sep 5, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Pulse Generator, Permanent, Implantable
    Trade Name
    CARELINK PROGRAMMER MODEL 2090 AND MODEL 9790/C PROGRAMMER
    PMA Number
    P890003
    Supplement Number
    S260
    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
    September 5, 2013
    Date Received
    September 13, 2012
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MULTIPLE DESIGN CHANGES, PACKAGING CHANGES, LABELING CHANGES, MANUFACTURING PROCESS CHANGES, AND A MANUFACTURING FACILITY TRANSFER TO TECHNICAL SERVICES FOR ELECTRONICS, INC., TSE TAIWAN MANUFACTURING FACILITY, WITH PACKAGING ACTIVITIES TO OCCUR AT THE TSE FACILITY IN JACKSON, MINNESOTA FOR THE 2090 EC/ECL ECG CABLE AND LEAD WIRES AND 148743 ECG PLUG.

    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