BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Catheter, Percutaneous, Long Term, Intraspinal

    PMA: P900052 · Supplement: S013 · Decision Apr 5, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    Catheter, Percutaneous, Long Term, Intraspinal
    Trade Name
    PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM
    PMA Number
    P900052
    Supplement Number
    S013
    Device Class
    FDA Class 3
    Product Code
    LNY
    Generic Name
    CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL
    Medical Specialty
    Unknown
    Advisory Committee
    General Hospital
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 5, 2007
    Date Received
    July 26, 2006
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A SECOND OPERATOR INSPECTION FOR OUTLET TUBE AND INSERT HOLE ALIGNMENT TO CONFIRM PROPER ALIGNMENT OF THE OUTLET TUBE.

    Classifications

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

    Product Code Device Name
    LNY Catheter, Percutaneous, Long Term, Intraspinal