PMA P970051S233

Device
Nucleus 24 Cochlear Implant System
Applicant
Cochlear Americas
PMA number
P970051
Supplement
S233
Product code
MCM
Decision date
2025-02-28
Classification
Ear, Nose, Throat
Generic name
Implant, cochlear
Approval order statement
adding Cochlear Chengdu (CCD) as a supplier of EA22 electrode array

Current openFDA PMA Record#

Device
Nucleus 24 Cochlear Implant System
Applicant
Cochlear Americas
PMA number
P970051
Supplement
S233
Product code
MCM
Generic name
Implant, cochlear
Decision date
2025-02-28
Decision code
OK30
Date received
2025-01-30
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
adding Cochlear Chengdu (CCD) as a supplier of EA22 electrode array