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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 NORTH
HOUSTON, TX 77386
PMA NumberP010023
Supplement NumberS002
Date Received08/19/2009
Decision Date10/08/2009
Product Code MPV 
Advisory Committee Ear Nose & Throat
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL TO CHANGE THE LABELING WITH A NEW PRODUCT NAME, MAXUM SYSTEM
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