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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, Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI and Spectra WaveWriter Spinal Cor
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantBoston Scientific Corp
25155 Rye Canyon Loop
Valencia, CA 91355
PMA NumberP030017
Supplement NumberS300
Date Received06/28/2017
Decision Date01/19/2018
Product Code LGW 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the addition of an alternate Ethylene Oxide sterilization site at the Boston Scientific St. Paul manufacturing site at 4100 Hamline Avenue North, St. Paul, Minnesota and new sterilization cycle parameters for that facility.
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