BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pulse-Generator, Program Module

    PMA: P880065 · Supplement: S004 · Decision Apr 21, 1999
    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
    S004
    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
    April 21, 1999
    Date Received
    February 19, 1998
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a manufacturing site located at SCIMED Life Systems, Inc., Two SCIMED Place, Maple Grove, MN 55311.

    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