BEUDAMED
    FDA Registration Active 🇺🇸 United States

    DBS Charging System (model 66700)

    Reg #: 3006705815 · FEI: 3006705815 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    31
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Abbott Medical
    Registration Number
    3006705815
    FEI Number
    3006705815
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    LOT A INTERIOR - No. 2 RD KM 67.5, SANTANA INDUSTRIAL PARK
    City
    Arecibo
    State
    PR
    ZIP
    00612
    Country
    US

    Regulatory Submissions

    PMA Number
    P140009

    Owner / Operator

    Firm Name
    ABBOTT LABORATORIES
    Operator Number
    1415939
    Address
    100 ABBOTT PARK RD., D-03Q3, AP52-1
    City
    Abbott Park
    State
    IL
    Postal Code
    60064
    Country
    US

    Products

    Device Name Product Code
    Stimulator, Electrical, Implanted, For Parkinsonian Tremor MHY
    Stimulator, Electrical, Implanted, For Essential Tremor PJS
    Stimulator, Electrical, Implanted, For Parkinsonian Symptoms NHL

    Proprietary Names

    DBS Charging System (model 66700) St. Jude Medical Patient Controller App St. Jude Medical Clinician Programmer App St. Jude Medical Infinity™ DBS System 8CH Flex Extn Charger (model 16000) Liberta RC™ DBS IPG (model 62400) 8-Channel Adapter Infinity™ 7 IPG, MDT Header NeuroSphere™ Patient Controller (model 55500) NeuroSphere™ Clinician Programmer (model 55600) Infinity™ 7 IPG Charging Apparel, lumbar (model 16750) St. Jude Medical Infinity™ DBS System 4CH Lead NeuroSphere Digital Health App (3876) St. Jude Medical Infinity™ DBS System 8CH Directional Lead Infinity™ 5 IPG Multi Lead Trial Cable (MLTC) Port Plug (model 12710) St. Jude Medical Infinity™ DBS System 4CH Extn Brio Implantable Pulse Generator Brio LE Charger Accessory Infinity™ 5 IPG, MDT Header 4 Channel DBS Lead St. Jude Medical Deep Brain Stimulator External Pulse Generator St. Jude Medical Infinity DBS System Brio LE Charging System Charger Kit - Pectoral (model 66000) 4 Channel DBS Extension Charging Apparel, pectoral (model 16760) St. Jude Medical Infinity™ DBS System 4CH Flex Extn Brio Patient Programmer

    Establishment Types

    Manufacture Medical Device