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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
Classification Nameimplant, hearing, active, middle ear, partially implanted
Generic Nameimplant, hearing, active, middle ear, partially implanted
Applicant
OTOTRONIX, LLC
26620 i-45 north
houston, TX 77386
PMA NumberP010023
Supplement NumberS010
Date Received06/13/2013
Decision Date09/13/2013
Product Code
MPV[ Registered Establishments with MPV ]
Advisory Committee Ear Nose & Throat
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR USER INTERFACE SOFTWARE CHANGES AND PATIENT FITTING CHANGES TO THE OPTIMAX PROGRAMMER SOFTWARE.
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