BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pulse Generator, Permanent, Implantable

    PMA: P880006 · Supplement: S071 · Decision Aug 3, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Pulse Generator, Permanent, Implantable
    Trade Name
    SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS
    PMA Number
    P880006
    Supplement Number
    S071
    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
    August 3, 2011
    Date Received
    May 2, 2011
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODEL 3330 PROGRAMMER SOFTWARE VERSION 10.1.2, WHICH INCLUDES MINOR MODIFICATIONS TO THE PACING LEAD IMPEDANCE FEATURE.

    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