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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 PARKWAY
WHITE BEAR LAKE, MN 55110
PMA NumberP090018
Supplement NumberS029
Date Received03/23/2015
Decision Date06/19/2015
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
Approval Order Statement  
APPROVAL FOR A CHANGE TO THE UV EPOXY MATERIAL IN THE HEADER CONNECTOR OF THE SOUND PROCESSOR AND FOR A NEW PLASMA PRE-TREATMENT STEP TO ENHANCE ADHESION OF THE SILICONE DIP COATING.
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