PMA P960058S040

Device
HIRESOLUTION BIONIC EAR SYSTEM
Applicant
Advanced Bionics
PMA number
P960058
Supplement
S040
Product code
MCM
Decision date
2005-03-07
Classification
Implant, Cochlear
Generic name
Implant, cochlear
Approval order statement
APPROVAL FOR UPGRADES TO THE AURIA POWERPAK FOR THE HIRES AURIA PROCESSOR (BEHIND-THE-EAR).

Current openFDA PMA Record#

Device
HIRESOLUTION BIONIC EAR SYSTEM
Applicant
Advanced Bionics
PMA number
P960058
Supplement
S040
Product code
MCM
Generic name
Implant, cochlear
Decision date
2005-03-07
Decision code
APPR
Date received
2004-12-14
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR UPGRADES TO THE AURIA POWERPAK FOR THE HIRES AURIA PROCESSOR (BEHIND-THE-EAR).