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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 Wavewriter Spinal Cord Stimulatror (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 NumberS291
Date Received05/05/2017
Decision Date08/03/2017
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 an update to the flash memory component used on the Printed Circuit Board Assembly (PCBA) in the Precision Spectra Wavewriter IPG because the current flash memory component is no longer available and needs to be replaced. BSN also indicated that the change will replace the current flash memory component with a new flash memory component from the same supplier and that the functionality of the IPG is unchanged.
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