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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 NumberS009
Date Received05/10/2011
Decision Date07/07/2011
Product Code OAF 
Advisory Committee Ear Nose & Throat
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE USER INTERFACE SOFTWARE CHANGE TO THE ESTEEM COMMANDER PROGRAMMER.
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