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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 NumberS011
Date Received06/15/2011
Decision Date11/13/2012
Product Code
OAF[ Registered Establishments with OAF ]
Advisory Committee Ear Nose & Throat
Supplement Type135 review track for 30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the eo sterilization load configuration change for the esteem product family.
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