DevicePMAs@therightstef:P950020_S010 JSONTXT

Approval for design, manufacturing, and labeling changes in the cutting balloon, both over-the-wire (otw) and monorail (mr) configurations. The device, as modified, will be marketed under the trade name flextome cutting balloon and is indicated for dilatation of stenoses in coronary arteries for the purpose of improving myocardial perfusion in those circumstances where a high pressure balloon resistant lesion is encountered.