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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 NameVIBRANT SOUNDBRIDGE IMPLANTABLE MIDDLE EAR HEARING DEVICE (IMEHD)
Classification Nameimplant, hearing, active, middle ear, partially implanted
Generic Nameimplantable middle ear hearing device
ApplicantVIBRANT MED-EL HEARING TECHNOLOGY GMBH
PMA NumberP990052
Supplement NumberS016
Date Received02/28/2007
Decision Date03/30/2007
Product Code
MPV[ Registered Establishments with MPV ]
Advisory Committee Ear Nose & Throat
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Update to the shelf-life information of the silicone rubbers and epoxies and change to the coating of the audio processor (ap) magnets from aluminum chromate iv to aluminum phosphate.
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