PMA P970051S167

Device
Nucleus 24 Cochlear Implant System
Applicant
Cochlear Americas
PMA number
P970051
Supplement
S167
Product code
MCM
Decision date
2017-08-16
Classification
Implant, Cochlear
Generic name
Implant, cochlear
Approval order statement
Addition of new molding equipment to manufacture the CP900 Series Sound Processors.

Current openFDA PMA Record#

Device
Nucleus 24 Cochlear Implant System
Applicant
Cochlear Americas
PMA number
P970051
Supplement
S167
Product code
MCM
Generic name
Implant, cochlear
Decision date
2017-08-16
Decision code
OK30
Date received
2017-07-17
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Addition of new molding equipment to manufacture the CP900 Series Sound Processors.