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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameX-STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM
Classification Nameprosthesis, spinous process spacer/plate
Generic Nameinterspinous process prosthesis
ApplicantMEDTRONIC
PMA NumberP040001
Supplement NumberS009
Date Received01/30/2008
Decision Date07/09/2008
Product Code
NQO[ Registered Establishments with NQO ]
Advisory Committee Orthopedic
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
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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