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. |
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Device | SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM STAR ANKLE |
Generic Name | Prosthesis, ankle, uncemented, non-constrained |
Applicant | DJO Global 9800 Metric Boulevard Austin, TX 78758 |
PMA Number | P050050 |
Supplement Number | S006 |
Date Received | 03/10/2014 |
Decision Date | 06/04/2014 |
Product Code |
NTG |
Advisory Committee |
Orthopedic |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGING THE INNER POUCH MATERIAL FOR THE STAR SLIDING CORE COMPONENT. |
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