| 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. |
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| Device | X STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM |
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| Generic Name | Prosthesis, spinous process spacer/plate |
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| Applicant | Medtronic Sofamor Danek, Inc.
1800 Pyramid Pl.
Memphis, TN 38132 |
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| PMA Number | P040001 |
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| Supplement Number | S002 |
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| Date Received | 03/01/2006 |
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| Decision Date | 08/08/2006 |
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| Withdrawal Date | 04/30/2015 |
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| Product Code |
NQO |
| Advisory Committee |
Orthopedic |
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| Supplement Type | Normal 180 Day Track |
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| Supplement Reason | Change Design/Components/Specifications/Material |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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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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