PMA P970051S234

Device
Nucleus® 24 Cochlear Implant System
Applicant
Cochlear Americas
PMA number
P970051
Supplement
S234
Product code
MCM
Decision date
2025-07-24
Classification
Ear, Nose, Throat
Generic name
Implant, cochlear
Approval order statement
automation of the paddle cutting process during implant manufacturing

Current openFDA PMA Record#

Device
Nucleus® 24 Cochlear Implant System
Applicant
Cochlear Americas
PMA number
P970051
Supplement
S234
Product code
MCM
Generic name
Implant, cochlear
Decision date
2025-07-24
Decision code
OK30
Date received
2025-06-24
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
automation of the paddle cutting process during implant manufacturing