|
Device | activL Artificial Disc |
Generic Name | Prosthesis, intervertebral disc |
Applicant | AESCULAP IMPLANT SYSTEMS, LLC 3773 Corporate Parkway Center Valley, PA 18034 |
PMA Number | P120024 |
Supplement Number | S007 |
Date Received | 11/06/2017 |
Decision Date | 08/10/2018 |
Product Code |
MJO |
Advisory Committee |
Orthopedic |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a manufacturing process flow change to the milling process for the PE inlay of the device. |