DevicePMAs@therightstef:P060008_S053 11 Projects
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Approval for: 1) a change of the supplier of toluene; and 2) a change to the incoming toluene specifications. The device is indicated for improving luminal diameter for the treatment of de novo lesions <= 28 mm in length in native coronary arteries >= 2.5 mm to <= 4.00 mm in diameter.
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