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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 NumberS297
Date Received06/13/2017
Decision Date12/21/2017
Product Code LGW 
Advisory Committee Neurology
Clinical TrialsNCT02314000
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for labeling changes associated with the demonstrated safety and effectiveness of subperception therapy.
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