FDA.reportPublic FDA data

PMA P970051S125

Device
NUCLEUS C1512 COCHLEAR IMPLANT SYSTEM
Applicant
Cochlear Americas
PMA number
P970051
Supplement
S125
Product code
MCM
Decision date
2014-12-12
Classification
Implant, Cochlear
Generic name
Implant, cochlear
Approval order statement
UPDATE THE ELECTRONIC ASSEMBLY INSPECTION STANDARD AND ALIGN THE ELECTRONIC ASSEMBLY INSPECTION STANDARD WITH THE CURRENT INSPECTION STANDARDS FOR THE NUCLEUS COCHLEAR IMPLANT SYSTEM.

Current openFDA PMA Record#

Device
NUCLEUS C1512 COCHLEAR IMPLANT SYSTEM
Applicant
Cochlear Americas
PMA number
P970051
Supplement
S125
Product code
MCM
Generic name
Implant, cochlear
Decision date
2014-12-12
Decision code
OK30
Date received
2014-11-12
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
UPDATE THE ELECTRONIC ASSEMBLY INSPECTION STANDARD AND ALIGN THE ELECTRONIC ASSEMBLY INSPECTION STANDARD WITH THE CURRENT INSPECTION STANDARDS FOR THE NUCLEUS COCHLEAR IMPLANT SYSTEM.