PMA P970051S108

Device
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Applicant
Cochlear Americas
PMA number
P970051
Supplement
S108
Product code
MCM
Decision date
2013-06-12
Classification
Implant, Cochlear
Generic name
Implant, cochlear
Approval order statement
APPROVAL FOR MODIFICATION TO THE CLEANING PROCESS FOR INTRACOCHLEAR ELECTRODES.

Current openFDA PMA Record#

Device
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Applicant
Cochlear Americas
PMA number
P970051
Supplement
S108
Product code
MCM
Generic name
Implant, cochlear
Decision date
2013-06-12
Decision code
APPR
Date received
2013-04-04
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
APPROVAL FOR MODIFICATION TO THE CLEANING PROCESS FOR INTRACOCHLEAR ELECTRODES.