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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 Spinal Cord Stimulator (SCS) System
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantBoston Scientific Corp
25155 Rye Canyon Loop
Valencia, CA 91355
PMA NumberP030017
Supplement NumberS294
Date Received05/23/2017
Decision Date06/21/2017
Product Code LGW 
Advisory Committee Neurology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Add 40 seconds delay between the Bootloader and application firmware download tests to the Precision® Spectra Implantable Pulse Generator (IPG) Packaging Automated Test Equipment (ATE) Test System.
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