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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 IPD SYSTEM
Classification Nameprosthesis, spinous process spacer/plate
Generic Nameinterspinous process prosthesis
ApplicantST. FRANCIS MEDICAL TECHNOLOGIES, INC.
PMA NumberP040001
Supplement NumberS003
Date Received09/19/2006
Decision Date10/19/2006
Product Code
NQO[ Registered Establishments with NQO ]
Advisory Committee Orthopedic
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Changes in packaging footprint, packaging processes, labeling processes and manufacturing flow for the device.
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