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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 AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEMS
Classification Namestimulator, spinal-cord, totally implanted for pain relief
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP030017
Supplement NumberS156
Date Received02/20/2013
Decision Date05/08/2013
Product Code
LGW[ Registered Establishments with LGW ]
Advisory Committee Neurology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - color additive
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a colorant change to the hub portion of the introducer, a surgical accessory for the precision spinal cord stimulation system that is used to facilitate placement of a lead into the epidural space.
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