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 mr conditional labeling for the activel keel endplates.
| Device | activeL Artificial Disc |
| Classification Name | Prosthesis, Intervertebral Disc |
| Generic Name | Prosthesis, Intervertebral Disc |
| Applicant | AESCULAP IMPLANT SYSTEMS, LLC |
| Date Received | 2019-03-29 |
| Decision Date | 2019-05-13 |
| PMA | P120024 |
| Supplement | S008 |
| Product Code | MJO |
| Advisory Committee | Orthopedic |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | AESCULAP IMPLANT SYSTEMS, LLC 3773 Corporate Parkway center Valley, PA 18034 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P120024 | Original Filing | |
| S012 | 2022-06-13 | 30-day Notice |
| S011 | 2019-12-06 | Normal 180 Day Track No User Fee |
| S010 | ||
| S009 | ||
| S008 | 2019-03-29 | Real-time Process |
| S007 | 2017-11-06 | 135 Review Track For 30-day Notice |
| S006 | ||
| S005 | 2017-02-24 | Normal 180 Day Track No User Fee |
| S004 | 2016-12-23 | Normal 180 Day Track |
| S003 | 2015-11-18 | Normal 180 Day Track No User Fee |
| S002 | 2015-08-07 | Real-time Process |
| S001 | 2015-07-24 | Real-time Process |