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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.
 
DevicePercision, Precision Spectra, Spectra WaveWriter; Precision Novi, Percision Montage and Percision Montage MRI Spinal Co
Generic Namestimulator, spinal-cord, totally implanted for pain relief
Applicant
Boston Scientific Corp.
25155 rye canyon loop
valencia, CA 91355
PMA NumberP030017
Supplement NumberS331
Date Received10/28/2019
Decision Date01/24/2020
Product Code LGW 
Advisory Committee Neurology
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for updating the Clinician Programmer (CP) computer to Surface Pro (SP6) with Windows 10 and for minor installation and labeling updates to the Bionic Navigator software used with the Precision, Precision Spectra, Spectra WaveWriter, Precision Novi, Precision Montage, and Precision Montage MRI Spinal Cord Stimulator (SCS) Systems.
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