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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
Generic NameImplant, hearing, active, middle ear, partially implanted
ApplicantOtotronix, LLC
26620 I-45 N.
Houston, TX 77386
PMA NumberP010023
Supplement NumberS011
Date Received05/29/2014
Decision Date05/04/2015
Product Code MPV 
Advisory Committee Ear Nose & Throat
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR CHANGING THE UNAIDED AIR CONDUCTION THRESHOLD UPPER LIMITS TO 60, 70, AND 85 DB HL AT FREQUENCIES OF 250, 500, AND 1000 HZ, RESPECTIVELY, AND TO 100 DB HL AT 2000, 3000, 4000, AND 6000 HZ AS PART OF THE PATIENT SELECTION CRITERIA.
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