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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceX-STOP INTERSPINOUS SPACER SYSTEM
Generic NameProsthesis, spinous process spacer/plate
ApplicantMedtronic Sofamor Danek, Inc.
1800 Pyramid Pl.
Memphis, TN 38132
PMA NumberP040001
Supplement NumberS019
Date Received03/08/2011
Decision Date05/04/2011
Withdrawal Date04/30/2015
Product Code NQO 
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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.
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