PMA P970051S156

Device
Nucleus 24 Cochlear Implant System
Applicant
Cochlear Americas
PMA number
P970051
Supplement
S156
Product code
MCM
Decision date
2017-03-09
Classification
Implant, Cochlear
Generic name
Implant, cochlear
Approval order statement
Change from adhesion to insert molding of the white silicone rubber alignment marker to the electrode.

Current openFDA PMA Record#

Device
Nucleus 24 Cochlear Implant System
Applicant
Cochlear Americas
PMA number
P970051
Supplement
S156
Product code
MCM
Generic name
Implant, cochlear
Decision date
2017-03-09
Decision code
OK30
Date received
2017-02-07
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Change from adhesion to insert molding of the white silicone rubber alignment marker to the electrode.