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 the revision of the physician guides and instructions for use to clarify the conditions under which the x-stop may be re-sterilized and to provide revised and more detailed instructions regarding attachment of the wing assembly to the spacer assembly.
| Device | X-STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM |
| Generic Name | Prosthesis, Spinous Process Spacer/plate |
| Applicant | MEDTRONIC SOFAMOR DANEK, INC. |
| Date Received | 2008-01-30 |
| Decision Date | 2008-07-09 |
| PMA | P040001 |
| Supplement | S009 |
| Product Code | NQO |
| Advisory Committee | Orthopedic |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 |