|Trade Name||MAVERICK 2 MONORAIL PTCA CATHETERS|
|Classification Name||catheters, transluminal coronary angioplasty, percutaneous|
|Applicant||BOSTON SCIENTIFIC SCIMED, INC.|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the maverick2 monorail ptca catheter. The device, as modified, will be marketed under the trade name maverick2 monorail ptca catheter and is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The maverick2 balloon catheter (2. 25 - 4. 00 mm) is also indicated for the post delivery expansion of balloon expandable stents.