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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 INTERSPINOUS PROCESS DECOMPRESSION SYSTEM
Generic NameProsthesis, spinous process spacer/plate
ApplicantMedtronic Sofamor Danek, Inc.
1800 Pyramid Pl.
Memphis, TN 38132
PMA NumberP040001
Supplement NumberS009
Date Received01/30/2008
Decision Date07/09/2008
Withdrawal Date04/30/2015
Product Code NQO 
Advisory Committee Orthopedic
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE REVISION OF THE PHYSICIAN GUIDES AND INSTRUCTIONS FOR USE TO CLARIFY THE CONDITIONS UNDER WHICH THE X-STOP MAY BE RE-STERILIZED AND TO PROVIDE REVISED AND MORE DETAILED INSTRUCTIONS REGARDING ATTACHMENT OF THE WING ASSEMBLY TO THE SPACER ASSEMBLY.
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