PMA P970051

Device
Nucleus® 24 Cochlear Implant System
Applicant
Cochlear Americas
PMA number
P970051
Supplement
S216
Product code
MCM
Decision date
2026-04-30
Generic name
Implant, cochlear
Approval order statement
manufacturing process changes at Cochlear's supplier for the CP1110 sound processor rechargeable batteries

Current openFDA PMA Record#

Device
Nucleus® 24 Cochlear Implant System
Applicant
Cochlear Americas
PMA number
P970051
Supplement
S242
Product code
MCM
Generic name
Implant, cochlear
Decision date
2026-04-30
Decision code
OK30
Date received
2026-03-31
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
manufacturing process changes at Cochlear's supplier for the CP1110 sound processor rechargeable batteries