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DevicePMAs@therightstef:P080020_S020 JSONTXT

Approval for Gel-One. The device is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to non-pharmacologic therapy, non-steroidal anti-inflammatory drugs (NSAIDs) or analgesics, e. g., acetaminophen.

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