|
Device | SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (S.T.A.R.ANKLE) |
Generic Name | Prosthesis, ankle, uncemented, non-constrained |
Applicant | DJO Global 9800 Metric Boulevard Austin, TX 78758 |
PMA Number | P050050 |
Supplement Number | S008 |
Date Received | 04/11/2016 |
Decision Date | 09/01/2016 |
Product Code |
NTG |
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 post-approval study protocol. |