PMA P960058S046

Device
HIRESOLUTION BIONIC EAR SYSTEM
Applicant
Advanced Bionics
PMA number
P960058
Supplement
S046
Product code
MCM
Decision date
2005-07-14
Classification
Implant, Cochlear
Generic name
Implant, cochlear
Approval order statement
APPROVAL FOR A NEW AURIA EARHOOK, THE ICONNECT, TO PROVIDE AN EAR-LEVEL, CABLE-FREE INTERFACE FOR THIRD-PARTY MINIATURE FM RECEIVERS.

Current openFDA PMA Record#

Device
HIRESOLUTION BIONIC EAR SYSTEM
Applicant
Advanced Bionics
PMA number
P960058
Supplement
S046
Product code
MCM
Generic name
Implant, cochlear
Decision date
2005-07-14
Decision code
APPR
Date received
2005-06-27
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR A NEW AURIA EARHOOK, THE ICONNECT, TO PROVIDE AN EAR-LEVEL, CABLE-FREE INTERFACE FOR THIRD-PARTY MINIATURE FM RECEIVERS.