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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 NumberS008
Date Received10/28/2010
Decision Date11/23/2010
Product Code
OAF[ Registered Establishments with OAF ]
Advisory Committee Ear Nose & Throat
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in the usb cable assembly, as well as the supplier for the cable, to be used with the esteem programmer.
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