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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
Classification Namestimulator, neuromuscular, implanted
Generic Namemotor control neuroprosthesis
Regulation Number882.5860
ApplicantNEUROCONTROL CORP.
PMA NumberP950035
Supplement NumberS006
Date Received02/29/2000
Decision Date07/05/2000
Product Code
GZC[ Registered Establishments with GZC ]
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the distribution of an intramuscular electrode and intramuscular electrode insertion tool kit as components to the freehand(tm) system, and labeling changes.
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