PMA P970051S184

Device
Nucleus 24 Cochlear Implant System
Applicant
Cochlear Americas
PMA number
P970051
Supplement
S184
Product code
MCM
Decision date
2019-03-08
Classification
Implant, Cochlear
Generic name
Implant, cochlear
Approval order statement
New wash solution for cleaning of the electronic assembly after solder operations.

Current openFDA PMA Record#

Device
Nucleus 24 Cochlear Implant System
Applicant
Cochlear Americas
PMA number
P970051
Supplement
S184
Product code
MCM
Generic name
Implant, cochlear
Decision date
2019-03-08
Decision code
OK30
Date received
2019-01-30
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
New wash solution for cleaning of the electronic assembly after solder operations.