PMA P960058S122

Device
HiResolution Bionic Ear System
Applicant
Advanced Bionics
PMA number
P960058
Supplement
S122
Decision date
2017-11-14
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.

Current openFDA PMA Record#

Device
HiResolution Bionic Ear System
Applicant
Advanced Bionics
PMA number
P960058
Supplement
S122
Decision date
2017-11-14
Decision code
APPR
Date received
2017-06-05
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
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.