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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.
 
DeviceSuperion® Indirect Decompression System
Generic NameProsthesis, spinous process spacer/plate
ApplicantBoston Scientific Neuromodulation
25155 Rye Canyon Loop
Valencia, CA 91355
PMA NumberP140004
Supplement NumberS010
Date Received11/16/2017
Decision Date11/16/2018
Product Code NQO 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for revised labeling which incorporates data from the completed Post-Approval Study.
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