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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameSOUNDTEC DIRECT IPCA SYSTEM
Classification Nameimplant, hearing, active, middle ear, partially implanted
Generic Nameimplantable middle ear hearing device
ApplicantOTOTRONIX, LLC
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 - component
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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