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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceESTEEM SYSTEM
Classification Nameimplant, hearing, active, middle ear, totally implanted
Generic Nameimplant, hearing, active, middle ear, totally implanted
Applicant
ENVOY MEDICAL CORPORATION
5000 township parkway
saint paul, MN 55110
PMA NumberP090018
Supplement NumberS025
Date Received03/12/2014
Decision Date04/08/2014
Product Code
OAF[ Registered Establishments with OAF ]
Advisory Committee Ear Nose & Throat
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Acceptance of a manufacturing process change for the esteem system.
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