PMA P970051S133

Device
NUCLEUS CI532 COCHLEAR IMPLANT SYSTEM
Applicant
Cochlear Americas
PMA number
P970051
Supplement
S133
Product code
MCM
Decision date
2016-03-16
Classification
Implant, Cochlear
Generic name
Implant, cochlear
Approval order statement
Approval for a new member of the CI500 series implant family in the Nucleus® Cochlear Implant System, the CI532 cochlear implant.

Current openFDA PMA Record#

Device
NUCLEUS CI532 COCHLEAR IMPLANT SYSTEM
Applicant
Cochlear Americas
PMA number
P970051
Supplement
S133
Product code
MCM
Generic name
Implant, cochlear
Decision date
2016-03-16
Decision code
APPR
Date received
2015-07-31
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for a new member of the CI500 series implant family in the Nucleus® Cochlear Implant System, the CI532 cochlear implant.