PMA P970051S158

Device
Nucleus 24 Cochlear Implant System
Applicant
Cochlear Americas
PMA number
P970051
Supplement
S158
Product code
MCM
Decision date
2017-03-29
Classification
Implant, Cochlear
Generic name
Implant, cochlear
Approval order statement
Manufacturing change to the CP950 Sound Processor.

Current openFDA PMA Record#

Device
Nucleus 24 Cochlear Implant System
Applicant
Cochlear Americas
PMA number
P970051
Supplement
S158
Product code
MCM
Generic name
Implant, cochlear
Decision date
2017-03-29
Decision code
OK30
Date received
2017-02-27
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Manufacturing change to the CP950 Sound Processor.