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.
| Device | activL Artificial Disc |
| Generic Name | Prosthesis, Intervertebral Disc |
| Applicant | AESCULAP IMPLANT SYSTEMS, LLC3773 Corporate Parkwaycenter Valley, PA 18034 PMA NumberP120024 Supplement NumberS012 Date Received06/13/2022 Decision Date06/24/2022 Product Code MJO Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-06-13 |
| Decision Date | 2022-06-24 |
| PMA | P120024 |
| Supplement | S012 |
| Product Code | MJO |
| Advisory Committee | Orthopedic |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | AESCULAP IMPLANT SYSTEMS, LLC 3773 Corporate Parkway center Valley, PA 18034 PMA NumberP120024 Supplement NumberS012 Date Received06/13/2022 Decision Date06/24/2022 Product Code MJO Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement Additional Raw Material Supplier (ordered To Specification) Of The ActivL Artificial Disc. |
| 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 |