PMA P970051S244

Device
Nucleus® 24 Cochlear Implant System
Applicant
Cochlear Americas
PMA number
P970051
Supplement
S244
Product code
MCM
Decision date
2026-09-28
Classification
Ear, Nose, Throat
Generic name
Implant, cochlear
Approval order statement
a change to the joining process in the manufacturing of the NEUF Child Lock component in Cochlear Sound Processors

Current openFDA PMA Record#

Device
Nucleus® 24 Cochlear Implant System
Applicant
Cochlear Americas
PMA number
P970051
Supplement
S244
Product code
MCM
Generic name
Implant, cochlear
Decision date
2026-09-28
Decision code
OK30
Date received
2026-08-31
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
a change to the joining process in the manufacturing of the NEUF Child Lock component in Cochlear Sound Processors