PMA P970051S074

Device
NUCLEUS COCHLEAR IMPLANT SYSTEM
Applicant
Cochlear Americas
PMA number
P970051
Supplement
S074
Product code
MCM
Decision date
2011-08-30
Classification
Implant, Cochlear
Generic name
Implant, cochlear
Approval order statement
APPROVAL FOR A CHANGE TO MOVE THE INNER AND OUTER MOULDING PROCESS OF A TRANSFORMER POD IN-HOUSE, AND MODIFY THE SHAPE OF THE INNER-MOULD.

Current openFDA PMA Record#

Device
NUCLEUS COCHLEAR IMPLANT SYSTEM
Applicant
Cochlear Americas
PMA number
P970051
Supplement
S074
Product code
MCM
Generic name
Implant, cochlear
Decision date
2011-08-30
Decision code
APPR
Date received
2011-05-19
Supplement type
135 Review Track For 30-Day Notice
Approval order statement
APPROVAL FOR A CHANGE TO MOVE THE INNER AND OUTER MOULDING PROCESS OF A TRANSFORMER POD IN-HOUSE, AND MODIFY THE SHAPE OF THE INNER-MOULD.