DevicePMAs@therightstef:P010029_S001 JSONTXT 11 Projects

Approval for 1) changing the storage conditions specified in the product labeling from, ?store in a cold dark place [2 ? 8 degrees c (36-46 degrees f)]. Protect from light. Do not freeze?. 2) change the specified shelf life time in the labeling form 3 years (at refrigerated temperatures) to 12 months. The device, as modified, will be marketed under the trade name euflexxa and 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 to simple analgesics (e. g., acetaminophen.)