BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pulse Generator, Permanent, Implantable

    PMA: P950037 · Supplement: S092 · Decision Feb 11, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Pulse Generator, Permanent, Implantable
    Trade Name
    ESTELLA AND EFFECTA PULSE GENERATORS
    PMA Number
    P950037
    Supplement Number
    S092
    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
    February 11, 2011
    Date Received
    December 13, 2010
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ICS 3000 PROGRAMMER APPLICATION SOFTWARE VERSION PSW 1004.U, AND THE ESTELLA DR; ESTELLA DR-T; ESTELLA SR; ESTELLA SR-T; ECURO DR; ECURO DR-T; ECURO SR; ECURO SR-T; EFFECTA D; EFFECTA DR; EFFECTA S; AND EFFECTA SR. THE DEVICE, AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAMES LISTED ABOVE, AND IS INDICATED FOR THE APPROVED INDICATION FOR USE.

    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