BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Catheter, Percutaneous, Long Term, Intraspinal

    PMA: P900052 · Supplement: S004 · Decision May 23, 1997
    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(R) EPIDURAL IMPLANTABLE ACCESS SYST
    PMA Number
    P900052
    Supplement Number
    S004
    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
    May 23, 1997
    Date Received
    February 23, 1996
    Supplement Type
    Normal 180 Day Track
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A CHANGE IN INDICATIONS FOR USE TO INCLUDE LONG-TERM, REPEATED ACCESS TO THE EPIDURAL SPACE FOR THE DELIVERY OF PRESERVATIVE-FREE MORPHINE SULFATE TO RELIEVE CHRONIC INTRACTABLE PAIN OF NON-MALIGNANT ORIGIN.

    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