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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 NumberS008
Date Received12/21/2010
Decision Date03/02/2011
Product Code MPV 
Advisory Committee Ear Nose & Throat
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
CHANGE TO THE IPC SHELL FABRICATION PROCESS.
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