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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 Place
Memphis, TN 38132
PMA NumberP040001
Supplement NumberS009
Date Received01/30/2008
Decision Date07/09/2008
Withdrawal Date 04/30/2015
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
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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