|Trade Name||(R) QUANTUM MONORAIL(TM) PTCA CATHETER|
|Classification Name||catheters, transluminal coronary angioplasty, percutaneous|
|Applicant||BOSTON SCIENTIFIC SCIMED, INC.|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the boston scientific scimed quantum monorail percutaneous transluminal coronary angioplasty (ptca) catheter (9, 12, 15, 18, and 20 mm lengths with balloon diameters of 2. 5 - 4. 0 mm in 1/4 mm increments). The quantum 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 quantum monorail ptca catheter (2. 5 - 4. 0 mm balloon diameters) is also indicated for the post-delivery expansion of balloon expandable stents.