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DevicePMAs@therightstef:P960058_S054 JSONTXT 11 Projects

Approval for a cochlear implant system name change from "hiresolution bionic ear system" to "harmony hiresolution bionic ear system". The device, as modified, will be marketed under the trade name harmony hiresolution bionic ear system and is indicated for adults and the pediatric population aged 12 months through 17 years, 11 months of age.

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