FDA.reportPublic FDA data

PMA P960058S148

Device
HiResolution Bionic Ear System
Applicant
Advanced Bionics
PMA number
P960058
Supplement
S148
Product code
MCM
Decision date
2020-05-28
Generic name
Implant, cochlear
Approval order statement
Facility move for the current supplier for manufacturing of the Printed Circuit Board Assemblies (PCBAs) for the Ultra Family of Implants, and the qualification of an alternate supplier to assemble the PCBAs for the Ultra 3D Implants.

Current openFDA PMA Record#

Device
HiResolution Bionic Ear System
Applicant
Advanced Bionics
PMA number
P960058
Supplement
S148
Product code
MCM
Generic name
Implant, cochlear
Decision date
2020-05-28
Decision code
OK30
Date received
2020-04-29
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Facility move for the current supplier for manufacturing of the Printed Circuit Board Assemblies (PCBAs) for the Ultra Family of Implants, and the qualification of an alternate supplier to assemble the PCBAs for the Ultra 3D Implants.