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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceMAXUM
Generic NameImplant, hearing, active, middle ear, partially implanted
ApplicantOTOTRONIX, LLC
26620 I-45 NORTH
HOUSTON, TX 77386
PMA NumberP010023
Supplement NumberS010
Date Received06/13/2013
Decision Date09/13/2013
Product Code MPV 
Advisory Committee Ear Nose & Throat
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR USER INTERFACE SOFTWARE CHANGES AND PATIENT FITTING CHANGES TO THE OPTIMAX PROGRAMMER SOFTWARE.
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