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PMA P970051S150

Device
NUCLEUS COCHLEAR IMPLANT SYSTEM
Applicant
Cochlear Americas
PMA number
P970051
Supplement
S150
Product code
MCM
Decision date
2016-10-21
Classification
Implant, Cochlear
Generic name
Implant, cochlear
Approval order statement
Introduction of a formal tool to measure the Q and tuned frequency of a finished implant in the Nucleus Cochlear Implant System and the Nucleus Auditory Brainstem Implant System.

Current openFDA PMA Record#

Device
NUCLEUS COCHLEAR IMPLANT SYSTEM
Applicant
Cochlear Americas
PMA number
P970051
Supplement
S150
Product code
MCM
Generic name
Implant, cochlear
Decision date
2016-10-21
Decision code
OK30
Date received
2016-09-22
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Introduction of a formal tool to measure the Q and tuned frequency of a finished implant in the Nucleus Cochlear Implant System and the Nucleus Auditory Brainstem Implant System.