BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Catheter, Percutaneous, Long Term, Intraspinal

    PMA: P900052 · Supplement: S016 · Decision Apr 20, 2009
    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 AND PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM
    PMA Number
    P900052
    Supplement Number
    S016
    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 20, 2009
    Date Received
    August 11, 2008
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A LABEL CLAIM ¿DOES NOT CONTAIN NATURAL RUBBER LATEX.¿

    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