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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 STIMULATION(SCS) SYSTEM
Generic Namestimulator, spinal-cord, totally implanted for pain relief
Applicant
Boston Scientific Corp.
25155 rye canyon loop
valencia, CA 91355
PMA NumberP030017
Supplement NumberS270
Date Received12/14/2016
Decision Date08/30/2017
Product Code LGW 
Advisory Committee Neurology
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a labeling change to designate Nevro Senza SCS System percutaneous leads and extensions as compatible to Boston Scientific Precision SCS devices (Implantable Pulse Generator, OR cable and extension/external trial stimulator (ETS), lead extensions, and tunneling tool) in the Directions for Use.
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