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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 NumberS002
Date Received06/29/1998
Decision Date07/28/1998
Product Code
GZC[ Registered Establishments with GZC ]
Advisory Committee Ear Nose & Throat
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Application submitted to inform the agency of the potential for device malfunction induced by electrostatic discharge and the changes being implementing to address the effects of esd on the device. The special supplement requested approval for revised manufacturing procedures, revised labeling for the clinician, and revised patient labeling.
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