|
Device | HiResolution Bionic Ear System |
Applicant | ADVANCED BIONICS 28515 WESTINGHOUSE PLACE VALENCIA, CA 91355 |
PMA Number | P960058 |
Supplement Number | S122 |
Date Received | 06/05/2017 |
Decision Date | 11/14/2017 |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval order for the Naida CI Q90 Acoustic Earhook (Acoustic Earhook) that is intended for use with the approved Naida CI Q90 Sound Processor. |