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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 AND PRECISION 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 NumberS230
Date Received06/26/2015
Decision Date09/22/2015
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 NEW LEAD ANCHOR CONFIGURATION. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CLIK X ANCHOR AND IS INDICATED FOR USE AS AN ANCHOR FOR SPINAL CORD STIMULATOR LEADS.
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