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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
Classification Namestimulator, neuromuscular, implanted
Generic Namemotor control neuroprosthesis
Regulation Number882.5860
ApplicantNEUROCONTROL CORP.
PMA NumberP950035
Supplement NumberS005
Date Received11/24/1999
Decision Date01/13/2000
Product Code
GZC[ Registered Establishments with GZC ]
Advisory Committee Ear Nose & Throat
Supplement Typereal-time process
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
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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