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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
Generic NameImplant, hearing, active, middle ear, totally implanted
ApplicantEnvoy Medical Corporation
4875 White Bear Pkwy.
White Bear Lake, MN 55110
PMA NumberP090018
Supplement NumberS030
Date Received09/23/2015
Decision Date03/18/2016
Product Code OAF 
Advisory Committee Ear Nose & Throat
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol - OSB
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of the following changes to the post-approval study for your device:change in sample size, removal of blinded audiologists, removal of requirement for x-ray ofimplanted device, change in follow-up point of evaluation and data gathering for safety objective.
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