BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pulse-Generator, Program Module

    PMA: P880065 · Supplement: S003 · Decision Sep 8, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Pulse-Generator, Program Module
    Trade Name
    MANSFIELD SCI. AORTIC VALVULOPLASTY CATHETER
    PMA Number
    P880065
    Supplement Number
    S003
    Device Class
    FDA Class 3
    Product Code
    LOT
    Generic Name
    PULSE-GENERATOR, PROGRAM MODULE
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 8, 1997
    Date Received
    March 5, 1997
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for: 1) an alternate manufacturing and sterilization facility; 2) use of the Oxyfume 2000 sterilant gas mixture for sterilization; 3) use of a parametric release instead of the biological indicators product release process; and 4) use of a revised labeling format, which replaces the Mansfield name with the SCIMED(R) name.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LOT Pulse-Generator, Program Module