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 | 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 | S001 |
Date Received | 05/18/2010 |
Decision Date | 03/09/2012 |
Product Code |
MJO |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MODIFIED SURGICAL TECHNIQUE, NEW INSTRUMENTATION, AND MODIFIED LABELING TO INCLUDE INFORMATION ON MRI COMPATIBILITY OF THE IMPLANTED DEVICE. |
|
|