FDA-Device2020-02-26Class III
HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. Cochlear Implant.
Advanced Bionics, LLC
Hazard
Three materials used in the makeup of the implant were mistakenly left off the list of bio-compatible materials in the firm's previously approved submission to the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan.
Sold states
No US distribution OUS: Japan
Affected count
4
Manufactured in
28515 Westinghouse Pl, Valencia, CA, United States
Products
HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. Cochlear Implant.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1259-2020Don't want to check this manually?
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