PMA P970051S162

Device
Nucleus 24 Cochlear Implant System
Applicant
Cochlear Americas
PMA number
P970051
Supplement
S162
Product code
MCM
Decision date
2017-05-23
Classification
Implant, Cochlear
Generic name
Implant, cochlear
Approval order statement
Alternate Flash Memory chip and ESD Diode, both of which are components of the Printed Circuit Board Assemblies used in the CP810 and CP802 Sound Processors.

Current openFDA PMA Record#

Device
Nucleus 24 Cochlear Implant System
Applicant
Cochlear Americas
PMA number
P970051
Supplement
S162
Product code
MCM
Generic name
Implant, cochlear
Decision date
2017-05-23
Decision code
OK30
Date received
2017-04-24
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Alternate Flash Memory chip and ESD Diode, both of which are components of the Printed Circuit Board Assemblies used in the CP810 and CP802 Sound Processors.