Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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Device | TRIVISC |
Generic Name | Acid, hyaluronic, intraarticular |
Applicant | ORTHOGENRX,INC 3805 OLD EASTON ROAD DOYLESTOWN, PA 18902-8400 |
PMA Number | P160057 |
Date Received | 12/23/2016 |
Decision Date | 11/13/2017 |
Product Code |
MOZ |
Docket Number | 17M-6525 |
Notice Date | 11/21/2017 |
Advisory Committee |
Orthopedic |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for TriVisc. The device is indicated for 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: |
S001 S002 |
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