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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 NumberS001
Date Received01/23/2006
Decision Date12/08/2006
Withdrawal Date 04/30/2015
Product Code NQO 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL OF THE POST-APPROVAL STUDY.
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