Note: 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 | activeL Artificial Disc |
Generic Name | Prosthesis, intervertebral disc |
Applicant | AESCULAP IMPLANT SYSTEMS, LLC 3773 Corporate Parkway Center Valley, PA 18034 |
PMA Number | P120024 |
Supplement Number | S008 |
Date Received | 03/29/2019 |
Decision Date | 05/13/2019 |
Product Code |
MJO |
Advisory Committee |
Orthopedic |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for MR Conditional labeling for the activeL keel endplates. |
|
|