DevicePMAs@therightstef:P990036_S001 JSONTXT

Approval for a modification to the existing radiation dosimetry protocol from a protocol that is based on intravascular ultrasound (ivus) to a protocol that prescribes a fixed dose of 14 gy at a distance of 2 mm from the centerline of the source and is indicated for the treatment of native coronary arteries (2.75 - 4.0 mm in diameter and lesions up to and including 45 mm in length) with in-stent restenosis following percutaneous revascularization using current interventional techniques.