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Device | SYNOJOYNT |
Generic Name | Acid, hyaluronic, intraarticular |
Applicant | Arthrex, Inc 1370 Creekside Boulevard Naples, FL 34108-1945 |
PMA Number | P170016 |
Date Received | 05/15/2017 |
Decision Date | 05/08/2018 |
Product Code |
MOZ |
Docket Number | 18M-1753 |
Notice Date | 05/22/2018 |
Advisory Committee |
Orthopedic |
Clinical Trials | NCT02495857
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Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for SYNOJOYNT. SYNOJOYNT is indicated for use in the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics (e.g., acetaminophen). |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Supplements: |
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