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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 NumberS004
Date Received06/20/2001
Decision Date07/24/2001
Product Code
MPV[ Registered Establishments with MPV ]
Advisory Committee Ear Nose & Throat
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modification to the mounting of the electronic module assembly, the microphone and the programming socket; change in the physical shape of the magnet from a notched-shape to a full round shape; change in the material of the tip cover of the audio processor (ap) to acrylonitrile-butadiene-styrene copolymer (abs) and addition of three different colors (light brown, brown and gray) to better match the hair colors of the final users; and pictorial and text changes to reflect the new shape and color of the ap in reference manual for audiologists and patient user manual.