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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 (IPD) SYSTEM
Classification Nameprosthesis, spinous process spacer/plate
Generic Nameinterspinous process prosthesis
ApplicantMEDTRONIC SPINE LLC.
PMA NumberP040001
Supplement NumberS012
Date Received04/24/2009
Decision Date01/28/2010
Product Code
NQO[ Registered Establishments with NQO ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a labeling change to add placement of the patient in the prone position during implantation of the device.
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