This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the x stop interspinous process decompression system. The device 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 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 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 PROCESS DECOMPRESSION SYSTEM |
| Generic Name | Prosthesis, Spinous Process Spacer/plate |
| Applicant | MEDTRONIC SOFAMOR DANEK, INC. |
| Date Received | 2004-01-06 |
| Decision Date | 2005-11-21 |
| Notice Date | 2006-01-13 |
| PMA | P040001 |
| Supplement | S |
| Product Code | NQO |
| Docket Number | 06M-0014 |
| Advisory Committee | Orthopedic |
| Expedited Review | Yes |
| Combination Product | No |
| Applicant Address | MEDTRONIC SOFAMOR DANEK, INC. 1800 Pyramid Place memphis, TN 38132 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| 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 |