This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the activl® artificial disc. This device is indicated for reconstruction of the disc at one level (l4-l5 or l5-s1) following single-level discectomy in skeletally mature patients with symptomatic degenerative disc disease (ddd) with no more than grade i spondylolisthesis at the involved level. Ddd is defined as discogenic back pain with degeneration of the disc confirmed by patient history, physical examination, and radiographic studies. The activl® artificial disc is implanted using an anterior retroperitoneal approach. Patients receiving the activl® artificial disc should have failed at least six months of nonoperative treatment prior to implantation of the device.
| Device | ACTIVL ARTIFICIAL DISC |
| Classification Name | Prosthesis, Intervertebral Disc |
| Generic Name | Prosthesis, Intervertebral Disc |
| Applicant | AESCULAP IMPLANT SYSTEMS, LLC |
| Date Received | 2012-12-18 |
| Decision Date | 2015-06-11 |
| Notice Date | 2015-07-17 |
| PMA | P120024 |
| Supplement | S |
| Product Code | MJO |
| Docket Number | 15M-2218 |
| Advisory Committee | Orthopedic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | AESCULAP IMPLANT SYSTEMS, LLC 3773 Corporate Parkway center Valley, PA 18034 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| 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 |