|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Trade Name||SCIMED MAVERICK(TM) MONORAIL(TM) (PTCA) CATHETER|
|Classification Name||catheters, transluminal coronary angioplasty, percutaneous|
|Applicant||BOSTON SCIENTIFIC SCIMED, INC.|
|Supplement Type||normal 180 day track|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the boston scientific scimed maverick(tm) monorail(tm) percutaneous transluminal coronary angioplasty (ptca) catheter (9, 12, 25, and 30 mm lengths with balloon diameters of 2. 0 - 4,0 mm in 1/4 mm increments, and 15 and 20 mm lengths with balloon diameters of 1. 5 mm and 2. 0 - 4. 0 mm in 1/4 mm increments. The maverick(tm) monorail ptca catheter 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 maverick(tm) monorail ptca catheter (2. 25 - 4. 0 mm balloon diameters) is also indicated for the post-delivery expansion of balloon expandable stents.