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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 E. 97th
Cleveland, OH 44106
PMA NumberP950035
Supplement NumberS005
Date Received11/24/1999
Decision Date01/13/2000
Product Code GZC 
Advisory Committee Ear Nose & Throat
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
1)Replace the MRI warning in the package insert,clinician manual and user manual with a precaution statement that provides information for performing MRI scanning of patients with the Freehand System; 2) modify the IDE card to include wording advising NeuroControl be contacted for information prior to MRI scanning; 3) "MRI Information Sheet" which provides guidance for MRI scanning will be provided upon request.
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