BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    PMA: P010032 · Supplement: S182 · Decision Nov 4, 2021
    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
    Eon Mini™ IPG, 16-Channel Rechargeable; Prodigy MRI IPG; Protégé IPG; Protégé MRI IPG; Eon Patient Programmer; Patient P
    PMA Number
    P010032
    Supplement Number
    S182
    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
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    November 4, 2021
    Date Received
    October 5, 2021
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Manufacturing site transfer of the printed circuit boards (PCBs) subassemblies used in several implantable pulse generators (IPGs) and their external accessories from its current site in 253 Financial Blvd. Liberty SC 29657, USA to another approved Abbott facility located in 8300 E. Pacesetter Way Scottsdale AZ 85255, USA

    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