|
Approval for design changes in the cutting balloon, both the over-the-wire (otw) and monorail (mr) configurations, and for manufacturing changes for the mr configuration. Additionally, approval to add the trade name cutting balloon ultra2 for both configurations and to add warnings to the instructions for use. The device, as modified, will be marketed under the trade name cutting balloon ultra2 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. In addition, the target lesion should posses the following characteristics: discrete (<= 15 mm in length) or tubular (10 to 20 mm in length); with a reference vessel diameter ranging from 2.0 mm to 4.0 mm; readily accessible to the device; light to moderate tortuosity of proximal vessel segment, non-angulated lesion segment (<45 degrees), smooth angiographic contour; and absence of angiographically-visible thrombus and/or calcification.
|
