BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    PMA: P840001 · Supplement: S062 · Decision Jul 25, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55

    Basic Information

    Device Name
    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
    Trade Name
    MEDTRONIC ITREL SPINAL CORD STIMULATION SYSTEM
    PMA Number
    P840001
    Supplement Number
    S062
    Device Class
    FDA Class 3
    Product Code
    LGW
    Generic Name
    Stimulator, spinal-cord, totally implanted for pain relief
    Medical Specialty
    Unknown
    Advisory Committee
    Neurology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 25, 2002
    Date Received
    May 20, 2002
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE MODEL 3550-16 EZ ANCHOR ACCESSORY KIT WHICH WILL BE LABELED FOR USE WITH THE FOLLOWING MEDTRONIC, INC. LEADS: PISCES-QUAD MODEL 3487A, RESUME MODEL 3587A, TEMPORARY SCREENING LEAD MODEL 3861, PISCES-QUAD COMPACT MODEL 3887, PISCES-QUAD PLUS MODEL 3888 AND THE PISCES-OCTAD MODEL 3898. THE MODEL 3550-16 EZ ANCHOR IS INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC, INTRACTABLE PAIN OF THE TRUNK OR LIMBS.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief