PMA P970051S174

Device
Nucleus 24 Cochlear Implant System
Applicant
Cochlear Americas
PMA number
P970051
Supplement
S174
Product code
MCM
Decision date
2018-02-01
Classification
Implant, Cochlear
Generic name
Implant, cochlear
Approval order statement
Change in inspection criteria to accept brazed chassis parts.

Current openFDA PMA Record#

Device
Nucleus 24 Cochlear Implant System
Applicant
Cochlear Americas
PMA number
P970051
Supplement
S174
Product code
MCM
Generic name
Implant, cochlear
Decision date
2018-02-01
Decision code
OK30
Date received
2018-01-02
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Change in inspection criteria to accept brazed chassis parts.