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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)
Generic NameStimulator, neuromuscular, implanted
Regulation Number882.5860
ApplicantBiocontrol Technology, Inc.
1945 E. 97th
Cleveland, OH 44106
PMA NumberP950035
Supplement NumberS001
Date Received02/10/1998
Decision Date03/20/1998
Product Code GZC 
Advisory Committee Ear Nose & Throat
Supplement TypeReal-Time Process
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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