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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.
Classification Nameimplant, hearing, active, middle ear, partially implanted
Generic Nameimplantable middle ear hearing device
PMA NumberP990052
Supplement NumberS003
Date Received03/09/2001
Decision Date04/02/2001
Product Code
MPV[ Registered Establishments with MPV ]
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to change the hinge boss and to change the negative battery contact. The indicatinos for ue for the device have not changed.