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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 & Novi Spinal Cord Stimulator (SCS) Systems; Precision Montage MRI and Precision Montage Spinal Cord S
Generic Namestimulator, spinal-cord, totally implanted for pain relief
ApplicantBoston Scientific Corp.
25155 rye canyon loop
valencia, CA 91355
PMA NumberP030017
Supplement NumberS257
Date Received08/31/2016
Decision Date09/29/2016
Product Code LGW 
Advisory Committee Neurology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Modify the software used to test the printed circuit board assembly in the Remote Control of your Spinal Cord Stimulation systems.
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