|Trade Name||SCIMED QUANTUM RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER|
|Classification Name||catheters, transluminal coronary angioplasty, percutaneous|
|Applicant||SCIMED LIFE SYSTEMS, INC.|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for new ptca catheter models. The devices, as modified, will be marketed under the trade names scimed(r) viva(tm) ptca catheters and scimed(r) long viva(tm) ptca catheters and are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.