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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.
 
Trade NameESTEEM
Classification Nameimplant, hearing, active, middle ear, totally implanted
ApplicantENVOY MEDICAL CORPORATION
PMA NumberP090018
Supplement NumberS009
Date Received05/10/2011
Decision Date07/07/2011
Product Code
OAF[ Registered Establishments with OAF ]
Advisory Committee Ear Nose & Throat
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the user interface software change to the esteem commander programmer.
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