FDA-Device2022-06-01Class II
Vanta INS Implantable Neurostimulator. Medtronic Model 977006 Vanta with AdaptiveStim Technology Neurostimulator with Surescan MRI technology, part of a neurostimulator system for pain therapy.
Medtronic Neuromodulation
Hazard
The Implantable Neurostimulator Model may be susceptible to not communicating with the clinical programmer and/or patient programmer system.
Sold states
Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and the countries of Italy, Sweden, Netherlands, Belgium, United Kingdom, Japan, Finland, Portugal, Spain, Canary Islands, Denmark, Germany, Switzerland, Ireland, Croatia, Norway.
Affected count
1021 devices
Manufactured in
7000 Central Ave Ne, Minneapolis, MN, United States
Products
Vanta INS Implantable Neurostimulator. Medtronic Model 977006 Vanta with AdaptiveStim Technology Neurostimulator with Surescan MRI technology, part of a neurostimulator system for pain therapy.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1123-2022Don't want to check this manually?
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