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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 NumberS036
Date Received05/10/2017
Decision Date06/09/2017
Product Code OAF 
Advisory Committee Ear Nose & Throat
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
New component supplier for the polyether ether ketone (PEEK) overmold component of the Esteem Model 7004/7010 Sensor assemblies and Model 7504/7510 Driver assemblies.
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