|Trade Name||QUANTUM MAVERICK MONORAIL & OTW PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETERS|
|Classification Name||catheters, transluminal coronary angioplasty, percutaneous|
|Applicant||BOSTON SCIENTIFIC CORP.|
|Supplement Type||real-time process|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for modification to the proximal weld process. The device, as modified, will be marketed under the trade name quantum maverick balloon catheters 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 quantum maverick balloon catheter (balloon models 2. 0 mm ¿ 5. 0 mm) is also indicated for the post-delivery expansion of balloon expandable stents.