DevicePMAs@therightstef:P080029_S000 / 155-169 JSONTXT

Approval for the quick-close vascular suturing system. this device is indicated as follows: the quick-close vascular suturing system is indicated to close femoral artery accesssites and to reduce time-to-hemostasis and time-to-ambulation in patients who haveundergone diagnostic or interventional endovascular procedures utilizing a 5, 6, 7, or 8french procedural sheath. additionally, the quick-close vascular suturing system is indicated to reduce time-to-hemostasis in patients who have undergone interventionalendovascular procedures utilizing a 5, 6, 7, or 8 french procedural sheath, who havereceived intraprocedural glycoprotein iib/iiia inhibitor therapy.

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PMA_MER 2 (2)