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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 NamePRECISION SPINAL CORD STIMULATOR SYSTEM
Classification Namestimulator, spinal-cord, totally implanted for pain relief
ApplicantADVANCED BIONICS CORP.
PMA NumberP030017
Supplement NumberS021
Date Received03/16/2007
Decision Date04/13/2007
Product Code
LGW[ Registered Establishments with LGW ]
Advisory Committee Neurology
Supplement Type30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in the adhesion process for the artisan 2 x 8 surgical lead electrodes of the device.
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