BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Autonomic Nerve, Implanted For Epilepsy

    PMA: P970003 · Supplement: S071 · Decision Oct 17, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    Stimulator, Autonomic Nerve, Implanted For Epilepsy
    Trade Name
    VNS THERAPY SYSTEM
    PMA Number
    P970003
    Supplement Number
    S071
    Device Class
    FDA Class 3
    Product Code
    LYJ
    Generic Name
    STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY
    Medical Specialty
    Unknown
    Advisory Committee
    Neurology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 17, 2006
    Date Received
    August 24, 2006
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FOLLOWING CHANGES TO THE LABELING HARMONIZATION AND MODULARIZATION FOR PHYSICIAN PULSE GENERATOR AND LEAD LABELING: 1) THE ADDITION OF A MANUAL ENTITLED, ?REVISION/REPLACEMENT/REMOVAL PROCEDURE MANUAL?. 2) THE INCORPORATION OF THE PHYSICIAN?S MANUAL FOR THE MODEL 303 LEAD INTO THE HARMONIZED LABELING WHICH INCLUDES THE ADDITION OF THE MODULAR PHYSICIAN?S MANUAL ENTITLED, ?TECHNICAL INFORMATION ? VNS THERAPY PERENNIA MODEL 303 LEAD?. 3) REVISIONS TO THE ?IMPLANTATION PROCEDURE? MODULE.

    Classifications

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

    Product Code Device Name
    LYJ Stimulator, Autonomic Nerve, Implanted For Epilepsy