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 labeling changes to the surgical technique and for the addition of the class iii activl® slim trial instruments and the activl® artificial disc ancillary trialing & confirmation instrument tray to the system
| Device | ACTIVL ARTIFICIAL DISC |
| Classification Name | Prosthesis, Intervertebral Disc |
| Generic Name | Prosthesis, Intervertebral Disc |
| Applicant | AESCULAP IMPLANT SYSTEMS, LLC |
| Date Received | 2016-12-23 |
| Decision Date | 2017-06-20 |
| PMA | P120024 |
| Supplement | S004 |
| Product Code | MJO |
| Advisory Committee | Orthopedic |
| Supplement Type | Normal 180 Day Track |
| 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 |