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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 Nameimplantable middle ear hearing device
ApplicantOTOTRONIX, LLC
PMA NumberP010023
Supplement NumberS004
Date Received08/31/2010
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 - component
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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