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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 INTERSPINOUS SPACER SYSTEM
Generic NameProsthesis, spinous process spacer/plate
ApplicantBoston Scientific Neuromodulation
25155 Rye Canyon Loop
Valencia, CA 91355
PMA NumberP140004
Supplement NumberS003
Date Received08/13/2015
Decision Date12/11/2015
Product Code NQO 
Advisory Committee Orthopedic
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A CHANGE IN SUPPLIER OF THE FOLLOWING MANUAL INSTRUMENTS: P/N 100-9135, P/N 100-9146, P/N 100-9136, P/N 100-9137, P/N 100-9117, P/N 100-9127, AND P/N 100-9139.
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