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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
Generic NameStimulator, neuromuscular, implanted
Regulation Number882.5860
ApplicantBIOCONTROL TECHNOLOGY, INC.
1945 EAST 97TH
CLEVELAND, OH 44106-4720
PMA NumberP950035
Supplement NumberS007
Date Received03/14/2000
Decision Date06/23/2000
Product Code GZC 
Advisory Committee Ear Nose & Throat
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE DISTRIBUTION OF AN IMPLANT TESTER ACCESSORY WHICH IS USED IN FINAL DEVICE TESTING AT THE COMPLETION OF SURGERY.
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