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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceMED-EL Cochlear Implant System
Classification Nameimplant, cochlear
Generic Nameimplant, cochlear
Applicant
MED-EL CORP.
furstenweg 77a
innsbruck 6020
PMA NumberP000025
Supplement NumberS104
Date Received07/30/2018
Decision Date07/19/2019
Product Code
MCM[ Registered Establishments with MCM ]
Docket Number 19M-3513
Notice Date 07/26/2019
Advisory Committee Ear Nose & Throat
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for expanding the cochlear implantation indications to include patients 5 years and above with single sided deafness (SSD) and asymmetric hearing loss (AHL) who have profound sensorineural hearing loss in one ear and normal hearing or mild sensorineural hearing loss in the other ear.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
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