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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 NumberS003
Date Received06/17/2010
Decision Date08/16/2010
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
Approval Order Statement  
APPROVAL OF THE POST-APPROVAL PROTOCOL.
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