|
Device | BRYAN CERVICAL DISC |
Generic Name | Prosthesis, intervertebral disc |
Applicant | Companion Spine France S.A.S Immeuble le Bridge 3 5 Allee des Acacias Merignac 33 70 |
PMA Number | P060023 |
Supplement Number | S002 |
Date Received | 04/15/2011 |
Decision Date | 09/13/2012 |
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 CHANGE TO THE INJECTION MOLDING PROCESS. |