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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.
 
DeviceSOUNDTEC DIRECT IPCA SYSTEM
Classification Nameimplant, hearing, active, middle ear, partially implanted
Generic Nameimplant, hearing, active, middle ear, partially implanted
Applicant
OTOTRONIX, LLC
26620 i-45 north
houston, TX 77386
PMA NumberP010023
Supplement NumberS001
Date Received11/21/2001
Decision Date09/04/2002
Product Code
MPV[ Registered Establishments with MPV ]
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE SOUNDTEC DIRECT IPCA SYSTEM. THE INDICATIONS FOR USE HAS NOT BEEN CHANGED.
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