DevicePMAs@therightstef:P110019_S025 / 275-283 JSONTXT

Approval for a newly designed delivery catheter. the device, as modified, will be marketed under the trade name xience xpedition; xience xpedition small vessel (sv) and xience xpedition long lesion (ll) everolimus eluting coronary stent system and is indicated for improving coronary luminal diameter in subjects with symptomatic heart disease due to de novo native coronary artery lesions (length <= 32mm) with reference vessel diameter of >=2.25mm to >=4.25mm.

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PMA_MER 1 (1)