DevicePMAs@therightstef:P110010_S090 11 Projects
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Approval for changes to the accessory kit (removal of clipit hypotube clips, substitution of flushing needle manufactured by new vendor, modification of carrier tube clip and update to the edfu) and is indicated for improving luminal diameter in patients with symptomatic heart disease or documented silent ischemia due to de novo lesions in native coronary arteries >=2.25 mm to <=4.00 mm in diameter in lesions <=34 mm in length.
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