PMA P970051S086

Device
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Applicant
Cochlear Americas
PMA number
P970051
Supplement
S086
Product code
MCM
Decision date
2011-12-02
Classification
Implant, Cochlear
Generic name
Implant, cochlear
Approval order statement
APPROVAL TO USE THE SAME CHIP AND BONDING MATERIAL EMPLOYED IN THE DESIGN OF THE CP180 SOUND PROCESSOR IN THE FREEDOM SOUND PROCESSOR.

Current openFDA PMA Record#

Device
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Applicant
Cochlear Americas
PMA number
P970051
Supplement
S086
Product code
MCM
Generic name
Implant, cochlear
Decision date
2011-12-02
Decision code
APPR
Date received
2011-08-29
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
APPROVAL TO USE THE SAME CHIP AND BONDING MATERIAL EMPLOYED IN THE DESIGN OF THE CP180 SOUND PROCESSOR IN THE FREEDOM SOUND PROCESSOR.