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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 SPACER SYSTEM
Generic NameProsthesis, spinous process spacer/plate
ApplicantMedtronic Sofamor Danek, Inc.
1800 Pyramid Pl.
Memphis, TN 38132
PMA NumberP040001
Supplement NumberS015
Date Received09/24/2009
Decision Date10/21/2009
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 CHANGES TO THE DEVICE NAME, INSTRUCTIONS FOR USE, AND PHYSICIAN¿S AND PATIENT¿S GUIDES.
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