PMA P970051S089

Device
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Applicant
Cochlear Americas
PMA number
P970051
Supplement
S089
Product code
MCM
Decision date
2012-02-28
Classification
Implant, Cochlear
Generic name
Implant, cochlear
Approval order statement
APPROVAL FOR THE CP800 SERIES SOFT EARHOOK, WHICH IS AN ACCESSORY TO THE CP810 SOUND PROCESSOR THAT ACTS AS AN ALTERNATIVE TO THE CURRENTLY MARKETED CP800 SERIES EARHOOK.

Current openFDA PMA Record#

Device
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Applicant
Cochlear Americas
PMA number
P970051
Supplement
S089
Product code
MCM
Generic name
Implant, cochlear
Decision date
2012-02-28
Decision code
APPR
Date received
2011-12-30
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR THE CP800 SERIES SOFT EARHOOK, WHICH IS AN ACCESSORY TO THE CP810 SOUND PROCESSOR THAT ACTS AS AN ALTERNATIVE TO THE CURRENTLY MARKETED CP800 SERIES EARHOOK.