DevicePMAs@therightstef:P830079_S014 JSONTXT

Approval for removal of the neurological exclusion from the "indications for use" statement. The device, as modified, will be marketed under the trade name instat absorbable collagen hemostat and is indicated for use "in surgical procedures (other than in ophthalmological surgery) as an adjunct to hemostasis when control of bleeding by ligature or other conventional procedures in ineffective or impractical. Instat hemostat can be cut to size for use in endoscopic procedures."