DevicePMAs@therightstef:P990030_S003 JSONTXT

Approval of the urological exclusion from the "indications for use" statement. The device, as modified, will be marketed under the trade names costasis/dynastat surgical hemostat and is indicated in surgical procedures (other than in neurosurgical and ophthalmic) as an adjunct to the hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.