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.
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.
| Device | X-STOP INTERSPINOUS SPACER SYSTEM |
| Generic Name | Prosthesis, Spinous Process Spacer/plate |
| Applicant | MEDTRONIC SOFAMOR DANEK, INC. |
| Date Received | 2011-03-08 |
| Decision Date | 2011-05-04 |
| PMA | P040001 |
| Supplement | S019 |
| Product Code | NQO |
| Advisory Committee | Orthopedic |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MEDTRONIC SOFAMOR DANEK, INC. 1800 Pyramid Place memphis, TN 38132 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P040001 | Original Filing | |
| S022 | 2014-08-26 | Normal 180 Day Track No User Fee |
| S021 | 2013-08-05 | Normal 180 Day Track No User Fee |
| S020 | 2012-02-29 | Normal 180 Day Track No User Fee |
| S019 | 2011-03-08 | Real-time Process |
| S018 | ||
| S017 | 2010-01-07 | Normal 180 Day Track No User Fee |
| S016 | 2009-11-05 | Normal 180 Day Track |
| S015 | 2009-09-24 | Special (immediate Track) |
| S014 | 2009-03-19 | 30-day Notice |
| S013 | 2009-01-09 | Normal 180 Day Track No User Fee |
| S012 | 2009-02-09 | Normal 180 Day Track |
| S011 | 2008-06-26 | Normal 180 Day Track No User Fee |
| S010 | ||
| S009 | 2008-01-30 | Special (immediate Track) |
| S008 | 2007-10-26 | Normal 180 Day Track No User Fee |
| S007 | 2007-06-06 | Normal 180 Day Track |
| S006 | ||
| S005 | 2007-03-30 | Normal 180 Day Track No User Fee |
| S004 | 2006-12-14 | 30-day Notice |
| S003 | 2006-09-19 | 30-day Notice |
| S002 | 2006-03-01 | Normal 180 Day Track |
| S001 | 2006-01-23 | Normal 180 Day Track No User Fee |