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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 NumberS004
Date Received07/07/2010
Decision Date04/08/2011
Product Code MPV 
Advisory Committee Ear Nose & Throat
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE CHANGE TO A DIGITAL PROCESSOR IN THE EXTERNAL INTEGRATED PROCESSOR AND COIL (IPC). THE MAXUM DIGITAL IPC REPLACES THE ANALOG PROCESSOR WITH A STANDARD COMMERCIAL DIGITAL PROCESSOR INTENDED FOR HEARING AID USE.
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