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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.
Classification Nameprosthesis, spinous process spacer/plate
Generic Nameinterspinous process prosthesis
PMA NumberP040001
Supplement NumberS019
Date Received03/08/2011
Decision Date05/04/2011
Product Code
NQO[ Registered Establishments with NQO ]
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for implementation of new instrument cleaning and sterilization processes and 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 spacer 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 spacer may be implanted at one or two lumbar levels in patients in whom operative treatment is indicated at no more than two levels.