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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 SYSTEM
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 NumberS007
Date Received10/25/2010
Decision Date05/10/2012
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 A DESIGN CHANGE TO THE WIREFORM COIL THAT IS USED TO ATTACH THE IMPLANT ASSEMBLY TO THE OSSICULAR CHAIN.
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