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 manufacturing sites located at medtorque, inc. , 612 w. Lamont road, elmhurst, illinois, for instrument machining and laser marking of the bryan™ and prestige lp instruments, and at medtronic sofamor danek usa, inc. , 4340 swinnea road, memphis, tennessee, for the manufacturing of prestige lp streamlined instrument.
| Device | PRESTIGE: LP(TM) CERVICAL DISC |
| Classification Name | Prosthesis, Intervertebral Disc |
| Generic Name | Prosthesis, Intervertebral Disc |
| Applicant | Medtronic Sofamor Danek USA, Inc. |
| Date Received | 2017-07-13 |
| Decision Date | 2018-01-31 |
| PMA | P090029 |
| Supplement | S008 |
| Product Code | MJO |
| Advisory Committee | Orthopedic |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place memphis, TN 38132 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P090029 | Original Filing | |
| S015 | 2020-10-21 | 30-day Notice |
| S014 | 2020-03-18 | 30-day Notice |
| S013 | 2019-09-26 | Normal 180 Day Track No User Fee |
| S012 | 2019-05-23 | Normal 180 Day Track No User Fee |
| S011 | 2018-10-31 | Normal 180 Day Track No User Fee |
| S010 | 2018-09-18 | Special (immediate Track) |
| S009 | 2017-12-11 | Normal 180 Day Track No User Fee |
| S008 | 2017-07-13 | Normal 180 Day Track No User Fee |
| S007 | 2016-12-22 | Normal 180 Day Track |
| S006 | 2016-08-05 | Normal 180 Day Track No User Fee |
| S005 | 2016-07-11 | 30-day Notice |
| S004 | 2015-09-02 | Normal 180 Day Track No User Fee |
| S003 | 2015-06-03 | Panel Track |
| S002 | 2014-08-22 | Normal 180 Day Track No User Fee |
| S001 | 2014-08-08 | Normal 180 Day Track No User Fee |