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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 SPACER SYSTEM
Classification Nameprosthesis, spinous process spacer/plate
Generic Nameinterspinous process prosthesis
ApplicantMEDTRONIC SOFAMOR DANEK, INC.
PMA NumberP040001
Supplement NumberS020
Date Received02/29/2012
Decision Date07/25/2012
Product Code
NQO[ Registered Establishments with NQO ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at medtronic sofamor danek usa, inc. In memphis, tennessee.
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