DevicePMAs@therightstef:P020026_S026 / 285-293 JSONTXT

Approval for the 4.0mm cypher sirolimus-eluting coronary stent on raptorrail (rx) delivery system. The device, as modified will be marketed under the trade name 4.00mm cypher sirolimus-eluting coronary stent on raptorrail rapid exchange delivery system and is indicated for improving coronary luminal diameter in patients with symptomatic ischemic disease due to discrete de novo lesions of length <= 30 mm in native coronary arteries with a reference vessel diameter of >= 2.25 to <= 4.0 mm.

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PMA_MER 1 (1)