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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.
 
DeviceX-STOP LTOS
Generic NameProsthesis, spinous process spacer/plate
ApplicantMedtronic Sofamor Danek, Inc.
1800 Pyramid Pl.
Memphis, TN 38132
PMA NumberP040001
Supplement NumberS021
Date Received08/05/2013
Decision Date12/12/2014
Withdrawal Date04/30/2015
Product Code NQO 
Advisory Committee Orthopedic
Clinical TrialsNCT00534092
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 AN UPDATE TO THE X STOP® INTERSPINOUS SPACER SYSTEM LABELING TO REFLECT THE RESULTS FROM THE LONG TERM OUTCOMES STUDY (LTOS) THAT WAS CONDUCTED AS A POSTAPPROVAL STUDY REQUIREMENT.
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