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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 NumberS007
Date Received03/14/2000
Decision Date06/23/2000
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 
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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