PMA P970051S192

Device
Nucleus 24 Cochlear Implant System (EA22 Stiffener)
Applicant
Cochlear Americas
PMA number
P970051
Supplement
S192
Product code
MCM
Decision date
2019-10-08
Classification
Implant, Cochlear
Generic name
Implant, cochlear
Approval order statement
Proposes the addition of a secondary supplier for the EA22 Stiffener.

Current openFDA PMA Record#

Device
Nucleus 24 Cochlear Implant System (EA22 Stiffener)
Applicant
Cochlear Americas
PMA number
P970051
Supplement
S192
Product code
MCM
Generic name
Implant, cochlear
Decision date
2019-10-08
Decision code
OK30
Date received
2019-09-09
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Proposes the addition of a secondary supplier for the EA22 Stiffener.