PMA P000025S092

Device
MED-EL EAS EXTENDED COCHLEAR IMPLANT SYSTEM
Applicant
Med-El Corp.
PMA number
P000025
Supplement
S092
Product code
PGQ
Decision date
2016-12-08
Classification
Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification
Generic name
Cochlear implant with combined electrical stimulation and acoustic amplification
Approval order statement
Approval of the protocol for the post-approval study.
Summary
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Current openFDA PMA Record#

Device
MED-EL EAS EXTENDED COCHLEAR IMPLANT SYSTEM
Applicant
Med-El Corp.
PMA number
P000025
Supplement
S092
Product code
PGQ
Generic name
Cochlear implant with combined electrical stimulation and acoustic amplification
Decision date
2016-12-08
Decision code
APPR
Date received
2016-10-13
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Postapproval Study Protocol
Approval order statement
Approval of the protocol for the post-approval study.