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 forfollowing changes to the activl® artificial disc enhanced safety surveillance survey:1) section: pain management; question 4: add n/a checkbox to the column, using spike endplate as now it is possible that a surgeon implanters experience would exclude the spike endplate and only include the keel endplate;2) section: spike vs. Keel endplate design; headerremove for surgeons outside the us only as now it is possible that a surgeon implanter within the u. S. Will have the option of the spike endplate and keel endplate. The following change to the aesculap activl® artificial disc enhanced safety surveillance study as follows:3) appendix aremove previous version of the activl® artificial disc enhanced safety surveillance survey and replaced it with the updated version reflecting the updates detailed above.
| Device | Aesculap activL Artificial Disc |
| Generic Name | Prosthesis, Intervertebral Disc |
| Applicant | AESCULAP IMPLANT SYSTEMS, LLC |
| Date Received | 2019-12-06 |
| Decision Date | 2020-01-31 |
| PMA | P120024 |
| Supplement | S011 |
| Product Code | MJO |
| Advisory Committee | Orthopedic |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol - Ode/oir |
| 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 |