BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Catheter, Percutaneous, Long Term, Intraspinal

    PMA: P900052 · Supplement: S012 · Decision Dec 17, 2002
    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, PORT-A-CATH EPIDURAL LOW PROFILE IMPLANTABLE ACCESS SYSTEM
    PMA Number
    P900052
    Supplement Number
    S012
    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
    December 17, 2002
    Date Received
    October 30, 2002
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR: 1) THE ADDITION OF PROCEDURAL ACCESSORIES TO THE PORT-A-CATH EPIDURAL SYSTEM KIT, 2) AN ALTERNATE PACKAGING CONFIGURATION AND 3) CHANGE IN ETHYLENE OXIDE RESIDUAL LIMITS. THESE ADDED ACCESSORIES ARE EXACTLY THE SAME AS THOSE DESCRIBED IN P900052/S005 FOR PORT-A-CATH II EPIDURAL LOW-PROFILE SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PORT-A-CATH EPIDURAL LOW PROFILE IMPLANTABLE ACCESS SYSTEM AND PORT-A-CATH EPIDURAL SYSTEM KITS.

    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