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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 may have changed. Be sure to look at the supplements 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 SOFAMOR DANEK, INC.
PMA NumberP040001
Date Received01/06/2004
Decision Date11/21/2005
Product Code
NQO[ Registered Establishments with NQO ]
Docket Number 06M-0014
Notice Date 01/13/2006
Advisory Committee Orthopedic
Expedited Review Granted? Yes
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Recalls CDRH 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 Order Approval Order
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 
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