DevicePMAs@therightstef:P990037_S001 JSONTXT 13 Projects

Approval for the change in diluent and procoagulant components. The device, as modified, will be marketed under the trade name diagnostic duett and is indicated for sealing femoral arterial puncture sites and reducing time to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular procedures using a 5f-9f introducer sheath with an overall length not exceeding 15.2 cm.

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