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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.
 
DeviceSOUNDTECH DIRECT AND MAXUM
Generic NameImplant, hearing, active, middle ear, partially implanted
ApplicantOtotronix, LLC
26620 I-45 N.
Houston, TX 77386
PMA NumberP010023
Supplement NumberS013
Date Received09/15/2015
Decision Date03/22/2016
Product Code MPV 
Advisory Committee Ear Nose & Throat
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a test fixture and inspection process change for the Magnet Canister Assembly (MCA).
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