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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceNEUROCONTROL FREEHAND SYSTEM(R)
Classification Namestimulator, neuromuscular, implanted
Generic Namestimulator, neuromuscular, implanted
Regulation Number882.5860
Applicant
BIOCONTROL TECHNOLOGY, INC.
1945 east 97th
cleveland, OH 44106-4720
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 Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
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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