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 of the post-approval study.
| Device | X-STOP INTERSPINOUS DECOMPRESSION SYSTEM |
| Generic Name | Prosthesis, Spinous Process Spacer/plate |
| Applicant | MEDTRONIC SOFAMOR DANEK, INC. |
| Date Received | 2007-03-30 |
| Decision Date | 2007-11-20 |
| PMA | P040001 |
| Supplement | S005 |
| Product Code | NQO |
| Advisory Committee | Orthopedic |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol - Osb |
| 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 |