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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.
 
DeviceEsteem® Totally Implantable Hearing System
Generic NameImplant, hearing, active, middle ear, totally implanted
ApplicantEnvoy Medical Corporation
4875 White Bear Pkwy.
White Bear Lake, MN 55110
PMA NumberP090018
Supplement NumberS041
Date Received03/23/2022
Decision Date08/24/2022
Product Code OAF 
Advisory Committee Ear Nose & Throat
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of final labeling changes for the post-approval study (PAS) referenced above. The updates to the final PAS labeling have been submitted to comply with the conditions of approval outlined in our approval order for P090018.
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