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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 SCS Systems; Precision Novi SCS Systems; Precision Montage MRI SCS Systems; Spectra Wave Writer SCS Sy
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantBoston Scientific Corp
25155 Rye Canyon Loop
Valencia, CA 91355
PMA NumberP030017
Supplement NumberS399
Date Received07/16/2026
Decision Date09/22/2026
Product Codes LGW QRB 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for an alternate battery for the Charger devices SC-5312 and NM-5312 which are used with the Boston Scientific Spinal Cord Stimulation (SCS) systems and Deep Brain Stimulation (DBS) systems, respectively.
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