Advanced Neuromodulation Systems, Inc

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Description

  • Manufacturer Address
    Advanced Neuromodulation Systems, Inc, 6901 Preston Rd, Plano TX 75024-2508
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA
  • 3 Events

3 devices in the database

  • Model / Serial
    Model number 3701 charging system is an accessory to the 3716 IPG; antennas are not serialized.
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide
  • Product Description
    Eon Rechargeable Implantable Pulse Generator (IPG) System
  • Model / Serial
    All lots.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide distribution: AZ, CA, CO, DC, FL, GA, IL, IN, MI, MO, MS, NC, NM, NJ, NV, NY, OH, OK, OR, PA, SC, TN, WA AND WV.
  • Product Description
    Swift-Lock (TM) Anchor Accessory Kit, Directions For Use Model 1192, ANS, A St. Jude Medical Company. || Product is intended to be used as an accessory to the leads component of ANS SCS systems, functioning to secure the lead to the fascia or interspinous/supraspinous ligament.
  • Model / Serial
    Device Code: 65-3788-01, Serial Numbers: 703271, 703287, 703050, 703051, 704169, 704476 and 704520.
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution -- GA, NC, CA, OK, SC and NJ.
  • Product Description
    Eon Mini Implantable Pulse Generator (IPG). Advanced Neuromodulation Systems, Inc. Plano, TX. || Indicated as an aid in the management of chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain.

One manufacturer with a similar name

Learn more about the data here

  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    SATP