BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Autonomic Nerve, Implanted For Epilepsy

    PMA: P970003 · Supplement: S081 · Decision May 14, 2007
    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 PULSE GENERATORS
    PMA Number
    P970003
    Supplement Number
    S081
    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
    May 14, 2007
    Date Received
    April 30, 2007
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO ADD ADDITIONAL PRECAUTIONARY INFORMATION TO THE MODEL 300 LEAD PHYSICIAN?S MANUAL AS AN ERRATA SHEET AND TO REVISE THE MODEL 102, 102R, 302 AND 303 VNS THERAPY PHYSICIAN?S MANUAL MODULE ENTITLED ?INTRODUCTION TO THE VNS THERAPY (SYSTEM INDICATIONS, CONTRAINDICATIONS, WARNINGS, AND PRECAUTIONS).?

    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