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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
Generic NameImplant, hearing, active, middle ear, partially implanted
ApplicantOtotronix, LLC
26620 I-45 N.
Houston, TX 77386
PMA NumberP010023
Supplement NumberS012
Date Received09/09/2015
Decision Date05/03/2016
Product Code MPV 
Advisory Committee Ear Nose & Throat
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a manufacturing site located at Ototronix LLC, 5000 Township Parkway, St. Paul, Minnesota to perform manufacturing and distribution.
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