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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceX STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM
Generic NameProsthesis, spinous process spacer/plate
ApplicantMEDTRONIC SOFAMOR DANEK, INC.
1800 Pyramid Place
Memphis, TN 38132
PMA NumberP040001
Date Received01/06/2004
Decision Date11/21/2005
Withdrawal Date 04/30/2015
Product Code NQO 
Docket Number 06M-0014
Notice Date 01/13/2006
Advisory Committee Orthopedic
Expedited Review Granted? Yes
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE X STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM. THE DEVICE IS INDICATED FOR TREATMENT OF PATIENTS AGED 50 OR OLDER SUFFERING FROM NEUROGENIC INTERMITTENT CLAUDICATION SECONDARY TO A CONFIRMED DIAGNOSIS OF LUMBAR SPINAL STENOSIS (WITH X-RAY, MRI, AND /OR CT EVIDENCE OF THICKENED LIGAMENTUM FLAVUM, NARROWED LATERAL RECESS AND/OR CENTRAL CANAL NARROWING). THE X STOP IS INDICATED FOR THOSE PATIENTS WITH MODERATELY IMPAIRED PHYSICAL FUNCTION WHO EXPERIENCE RELIEF IN FLEXION FROM THEIR SYMPTOMS OF LEG/BUTTOCK/GROIN PAIN, WITH OR WITHOUT BACK PAIN, AND HAVE UNDERGONE A REGIMEN OF AT LEAST 6 MONTHS OF NONOPERATIVE TREATMENT. THE X STOP MAY BE IMPLANTED AT ONE OR TWO LUMBAR LEVELS IN PATIENTS IN WHOM OPERATIVE TREATMENT IS INDICATED AT NO MORE THAN TWO LEVELS.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 S007 S008 S009 S011 S012 S013 
S014 S015 S016 S017 S019 S020 S021 S022 
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