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.
Changes in packaging footprint, packaging processes, labeling processes and manufacturing flow for the device.
| Device | X-STOP IPD SYSTEM |
| Generic Name | Prosthesis, Spinous Process Spacer/plate |
| Applicant | MEDTRONIC SOFAMOR DANEK, INC. |
| Date Received | 2006-09-19 |
| Decision Date | 2006-10-19 |
| PMA | P040001 |
| Supplement | S003 |
| Product Code | NQO |
| Advisory Committee | Orthopedic |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |