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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 (IPD) SYSTEM
Generic NameProsthesis, spinous process spacer/plate
ApplicantMedtronic Sofamor Danek, Inc.
1800 Pyramid Pl.
Memphis, TN 38132
PMA NumberP040001
Supplement NumberS004
Date Received12/14/2006
Decision Date12/29/2006
Withdrawal Date04/30/2015
Product Code NQO 
Advisory Committee Orthopedic
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
TRANSFER OF RECEIVING, INSPECTION, ACCEPTANCE OF FINISHED GOODS, WAREHOUSING AND DISTRIBUTION FUNCTIONS TO THE NEW HEADQUARTERS FACILITY.
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