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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 NumberS008
Date Received07/11/2000
Decision Date11/14/2000
Product Code
GZC[ Registered Establishments with GZC ]
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for 1) changing the manufacturing site for the freehand implantable receiver-stimulator to lewicki microelectronic, gmbh; 2) addition of a radiographic identification label to the implantable receiver-stimulator; and 3) implementing several design modifications involving the encapsulating material and circuitry of the freehand implantable receiver-stimulator.