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 | Aesculap Implant Systems |
Generic Name | Prosthesis, intervertebral disc |
Applicant | AESCULAP IMPLANT SYSTEMS, LLC 3773 Corporate Parkway Center Valley, PA 18034 |
PMA Number | P120024 |
Supplement Number | S005 |
Date Received | 02/24/2017 |
Decision Date | 04/26/2017 |
Product Code |
MJO |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol - OSB |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of changes to the protocol for the post-approval study (PAS) protocol. |
|
|