BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pulse Generator, Permanent, Implantable

    PMA: P990001 · Supplement: S028 · Decision Jul 10, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Pulse Generator, Permanent, Implantable
    Trade Name
    VITATRON
    PMA Number
    P990001
    Supplement Number
    S028
    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
    July 10, 2007
    Date Received
    February 26, 2007
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATIONS TO THE VITATRON FAMILY APPLICATION SOFTWARE MODELS THAT SUPPORT THE DIVA, DEMA AND SELECTION AFM 902 DEVICES (VSC02 VERSION 9.1 SR1), C-SERIES DEVICES A1 MODELS (VSF04 VERSION 1.3), C-SERIES DEVICES A3 MODELS (VSF12 VERSION 1.2, AND T-SERIES DEVICES (VSF08 VERSION 1.6). THE MODIFICATIONS WILL UPDATE THE EMI BEHAVIOR OF YOUR DEVICE, CORRECT THE ISSUE OF DA+ INHIBITION OF PACING BELOW THE PROGRAMMED THRESHOLD, IDENTIFY TO THE USER INACCURATE COULOMB COUNTS, ALLOW THE APPLICATION SUITE TO BE SPLIT INTO SEVERAL APPLICATION PACKAGES, AND MINOR SOFTWARE ENHANCEMENTS.

    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