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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DevicePRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantBoston Scientific Corp.
25155 Rye Canyon Loop
Valencia, CA 91355
PMA NumberP030017
Supplement NumberS168
Date Received05/22/2013
Decision Date08/06/2013
Product Code LGW 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A CHANGE OF THE OUTER BOX USED AS SECONDARY PACKAGINGFOR THE PRECISION SPECTRA IMPLANTED PULSE GENERATOR, AND THE SPECTRA OPERATING ROOM CABLE/EXTENSION KITS.
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