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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.
 
DeviceSPECTRA WAVEWRITER SPINAL CORD STIMULATOR SYSTEM
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantBoston Scientific Corp.
25155 Rye Canyon Loop
Valencia, CA 91355
PMA NumberP030017
Supplement NumberS271
Date Received12/16/2016
Decision Date03/13/2017
Product Code LGW 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for firmware/software updates to their Precision Spectra System Implantable Pulse Generator (IPG)/External Trial Stimulator (ETS), Freelink Remote Control (RC) and the Bionic Navigator (BN) Software. The Precision Spectra System will be rebranded under the name Spectra WaveWriter SCS System. The firmware/software has been updated to support new features. No changes were made to the hardware or material of any components in the existing system.
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