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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 NumberS024
Date Received08/08/2013
Decision Date11/04/2013
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 CHANGES TO THE INTRAOPERATIVE SYSTEM ANALYZER (ISA) SOFTWARE.
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