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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
Generic Nameprosthesis, spinous process spacer/plate
Applicant
Boston Scientific Neuromodulation
25155 rye canyon loop
valencia, CA 91355
PMA NumberP140004
Supplement NumberS001
Date Received06/22/2015
Decision Date11/18/2015
Product Code NQO 
Advisory Committee Orthopedic
Supplement Typenormal 180 day track no user fee
Supplement Reason postapproval study protocol
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL OF POST-APPROVAL STUDY 1 FOR THE DEVICE.
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