BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Catheter, Percutaneous, Long Term, Intraspinal

    PMA: P860064 · Supplement: S008 · Decision Aug 8, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    Catheter, Percutaneous, Long Term, Intraspinal
    Trade Name
    DUPEN LONG TERM EPIDURAL CATHETER
    PMA Number
    P860064
    Supplement Number
    S008
    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
    August 8, 1997
    Date Received
    May 5, 1997
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A CHANGE IN THE STERILANT FORM 12% FREON/ 88% ETHYLENE OSIDE TO 100% ETHYLENE OXIDE AND TO CHANGE THE STERILIZATION FACILITY FROM DAVOL, INC., A C.R. BARD FACILITY IN CRANSTON, R.I., TO A CONTRACT STERILIZER, SOREX MEDICAL, INC., IN SALT LAKE CITY, UTAH.

    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