BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pulse Generator, Permanent, Implantable

    PMA: P990001 · Decision Sep 27, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Pulse Generator, Permanent, Implantable
    Trade Name
    DIVA PLATFORM IMPLANTABLE PULSE GENERATORS AND PRO VIT APPLICATION SOFTWARE VERSION 3.3.2
    PMA Number
    P990001
    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 27, 1999
    Date Received
    January 9, 1999
    Expedited Review
    N
    Docket Number
    99M-4281

    Advisory Committee Statement

    Approval for the Diva Platform Implantable Pulse Generators and the ProVit III Application Software (version 3.3.2) including the Diamond II Model 820 PUlse Generator; the Ruby II Model 720 Pulse Generator; the Topaz II Model 520 Pulse Generator; the Jade II Model 220 Pulse Generator; the Vita DDR Moel 810 Pulse Generator; the Vita DDD Model 710 Pulse Generator; the Vita VVIR Model 310 Pulse Generator.

    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