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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.
 
DeviceImplantable Pulse Generator (IPG), Precision Spectra, Spectra WaveWriter, Precision Novi, Precision Montage, and Precisi
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantBoston Scientific Corp.
25155 Rye Canyon Loop
Valencia, CA 91355
PMA NumberP030017
Supplement NumberS329
Date Received08/16/2019
Decision Date09/13/2019
Product Code LGW 
Advisory Committee Neurology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Use of alternate cleaning equipment for the initial cleaning process for the Printed Circuit Board Assemblies (PCBAs) of the Implantable Pulse Generators (IPGs) for the Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI, and Spectra WaveWriter Spinal Cord Stimulator (SCS) Systems.
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