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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 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 NumberS100
Date Received02/18/2010
Decision Date07/19/2010
Product Code LGW 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE INTRODUCTION OF THE LINEAR 3-4 AND 3-6 SPINAL CORD STIMULATION LEADS, WHICH HAVE ELECTRODE CONTACT SPACINGS OF 4 MM AND 6 MM, RESPECTIVELY.
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