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 modifications to the prestige lp streamlined instrument labeling (surgical technique document) to reference new drill bits to be used with the system to enhance the safe use of the device.
| Device | PRESTIGE LP Cervical Disc |
| Classification Name | Prosthesis, Intervertebral Disc |
| Generic Name | Prosthesis, Intervertebral Disc |
| Applicant | Medtronic Sofamor Danek USA, Inc. |
| Date Received | 2018-09-18 |
| Decision Date | 2018-09-27 |
| PMA | P090029 |
| Supplement | S010 |
| Product Code | MJO |
| 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 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 |