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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 NameNEUROCONTROL FREEHAND SYSTEM(R)
Classification Namestimulator, neuromuscular, implanted
Generic Namemotor control neuroprosthesis
Regulation Number882.5860
ApplicantNEUROCONTROL CORP.
PMA NumberP950035
Supplement NumberS001
Date Received02/10/1998
Decision Date03/20/1998
Product Code
GZC[ Registered Establishments with GZC ]
Advisory Committee Ear Nose & Throat
Supplement Typereal-time process
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in the supplier of the platinum-iridium (pt-ir) electrode discs used in the manufacture of the freehand epimysial electrodes and a change in the model numbering for the freehand system.
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