PMA P970051S210

Device
Nucleus 24 Cochlear Implant System
Applicant
Cochlear Americas
PMA number
P970051
Supplement
S210
Product code
MCM
Decision date
2022-03-11
Generic name
Implant, cochlear
Approval order statement
Approval for the PAS protocol which has been submitted to comply with the conditions of approval.

Current openFDA PMA Record#

Device
Nucleus 24 Cochlear Implant System
Applicant
Cochlear Americas
PMA number
P970051
Supplement
S210
Product code
MCM
Generic name
Implant, cochlear
Decision date
2022-03-11
Decision code
APPR
Date received
2022-02-08
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Postapproval Study Protocol
Approval order statement
Approval for the PAS protocol which has been submitted to comply with the conditions of approval.