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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 PROCESS DECOMPRESSION SYSTEM
Classification Nameprosthesis, spinous process spacer/plate
Generic Nameinterspinous process prosthesis
ApplicantST. FRANCIS MEDICAL TECHNOLOGIES, INC.
PMA NumberP040001
Supplement NumberS002
Date Received03/07/2006
Decision Date08/08/2006
Product Code
NQO[ Registered Establishments with NQO ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the x stoppk, a modified version of the x stop that includes a peek spacer and additional 16 mm spacer size. The device, as modified, will be marketed under the trade name x stoppk 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 thickening ligamentum flavum, narrowed lateral recess and/or central conal narrowing). The x stoppk 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 stoppk may be implanted at one or two lumbar levels in patients in whom operative treatment is indicated at no more than two levels.
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