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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
Generic NameImplant, cochlear
ApplicantMed-El Corp.
Furstenweg 77a
Innsbruck 6020
PMA NumberP000025
Supplement NumberS137
Date Received12/22/2025
Decision Date01/23/2026
Product Code MCM 
Advisory Committee Ear Nose & Throat
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of your premarket approval application (PMA) supplement, which requested approval of the protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P000025/S134 Based upon the information submitted, the PMA supplement is approved.
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