DevicePMAs@therightstef:P990004_S012 / 29-37
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Approval for the addition of clinical results to the product labeling with an update to the directions for use to allow use in endoscopic nasal sinus surgery and addition of a bendable applicator tip (flextip). The device, as modified, will be marketed under the trade name surgifoam absorbable gelatin sponge, u. s. p. and is indicated for an adjunct to hemostasis during surgical procedures.
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projects
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