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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.
Classification Namestimulator, neuromuscular, implanted
Generic Namemotor control neuroprosthesis
Regulation Number882.5860
PMA NumberP950035
Supplement NumberS009
Date Received12/22/2000
Decision Date01/18/2002
Product Code
GZC[ Registered Establishments with GZC ]
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the universal external controller (uec), revised freehand clinician programming interface software, version 5. 0, which are used to operate and program the freehand implantable-receiver stimulator, and subsequent changes to the labeling. The device, as modified, will be marketed under the trade name freehand ii system.