PMA P970051S189

Device
Nucleus 24 Cochlear Implant System
Applicant
Cochlear Americas
PMA number
P970051
Supplement
S189
Product code
MCM
Decision date
2019-08-27
Classification
Implant, Cochlear
Generic name
Implant, cochlear
Approval order statement
Addition of an automated punch and form tool for coil and hardball crimps.

Current openFDA PMA Record#

Device
Nucleus 24 Cochlear Implant System
Applicant
Cochlear Americas
PMA number
P970051
Supplement
S189
Product code
MCM
Generic name
Implant, cochlear
Decision date
2019-08-27
Decision code
OK30
Date received
2019-07-31
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Addition of an automated punch and form tool for coil and hardball crimps.