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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 NameBTE(BEHIND-THE-EAR)T-MIC
Classification Nameimplant, cochlear
Generic Namecochlear implant (adult)
ApplicantADVANCED BIONICS CORP.
PMA NumberP940022
Supplement NumberS020
Date Received04/12/2002
Decision Date04/23/2002
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the bte t-mic, and in-the-ear microphone accessory item to be offered for use with the bte sound processor, and approval of the hifocus i surgical instruction video, which will be distributed as part of the surgeon's kit.
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