FDA.reportPublic FDA data

PMA P000015S015

Device
NUCLEUS AUDITORY BRAINSTEM IMPLANT
Applicant
Cochlear Americas
PMA number
P000015
Supplement
S015
Product code
MHE
Decision date
2016-10-21
Classification
Implant, Auditory Brainstem
Generic name
Implant, auditory brainstem
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 AUDITORY BRAINSTEM IMPLANT
Applicant
Cochlear Americas
PMA number
P000015
Supplement
S015
Product code
MHE
Generic name
Implant, auditory brainstem
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.