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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 Namestimulator, neuromuscular, implanted
Regulation Number882.5860
1945 east 97th
cleveland, OH 44106-4720
PMA NumberP950035
Supplement NumberS010
Date Received08/14/2001
Decision Date09/13/2001
Product Code
GZC[ Registered Establishments with GZC ]
Advisory Committee Ear Nose & Throat
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for revisions to the labeling that specify the maximum depth below the surface of the skin at which the implantable receiver-stimulator (irs) should not exceed when implanted and clarifying the instructions for connecting the external controller to the clinical programming station.