BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Catheter, Percutaneous, Long Term, Intraspinal

    PMA: P900052 · Supplement: S008 · Decision Sep 23, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    Catheter, Percutaneous, Long Term, Intraspinal
    Trade Name
    PORTACATH/II EPIDURAL LOW PROFILE IMPLANTABLE ACCESS SYSTEM
    PMA Number
    P900052
    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
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    September 23, 1999
    Date Received
    September 7, 1999
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    The 30-day Notice requested a manufacturing process change for the Port-A-Cath(R) Epidural Implantable Access System and for the Port-A-Cath(R)II Epidural Low Profile(TM) Implantable Access System. This change would allow the use of an automated turbidometric assay method for determination of pyrogens using the LAL-5000 System with PYROS Software.

    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