PMA P970051S130

Device
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Applicant
Cochlear Americas
PMA number
P970051
Supplement
S130
Product code
MCM
Decision date
2015-12-04
Classification
Implant, Cochlear
Generic name
Implant, cochlear
Approval order statement
APPROVAL FOR THE ADDITION OF AN ALTERNATIVE AUTOMATED ELECTRODE PAD CLEANING METHOD USING LASER ABLATION.

Current openFDA PMA Record#

Device
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Applicant
Cochlear Americas
PMA number
P970051
Supplement
S130
Product code
MCM
Generic name
Implant, cochlear
Decision date
2015-12-04
Decision code
APPR
Date received
2015-05-07
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
APPROVAL FOR THE ADDITION OF AN ALTERNATIVE AUTOMATED ELECTRODE PAD CLEANING METHOD USING LASER ABLATION.