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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 NameMAXUM SYSTEM
Classification Nameimplant, hearing, active, middle ear, partially implanted
Generic Nameimplant, hearing, active, middle ear, partially implanted
ApplicantOTOTRONIX, LLC
PMA NumberP010023
Supplement NumberS004
Date Received07/07/2010
Decision Date04/08/2011
Product Code
MPV[ Registered Establishments with MPV ]
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the change to a digital processor in the external integrated processor and coil (ipc). The maxum digital ipc replaces the analog processor with a standard commercial digital processor intended for hearing aid use.
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