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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 and Spectra Wave Writer Spinal Cord Stimulator (SCS) Systems
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantBoston Scientific Corp
25155 Rye Canyon Loop
Valencia, CA 91355
PMA NumberP030017
Supplement NumberS327
Date Received06/17/2019
Decision Date09/13/2019
Product Code LGW 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the addition of the 50 cm Infinion CX Lead (SC-2317-50) and the 50 cm Artisan MRI lead (SC-8416-50) to the head-only MR conditional labeling for the Precision Spectra and Spectra WaveWriter spinal cord stimulator (SCS) systems.
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