|Trade Name||SCIMED JAZ 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 - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a modification of the scimed ranger(tm) ptca catheter, with the primary difference being use of a new balloon material. The device, as modified, will be marketed under the trade name scimed(r) coyote(tm) percutaneous transluminal angioplasty coronary (ptca) catheter and is indicated for the balloon dilatation of coronary arteries or bypass graft stenoses for the prupose of improving myhocardial perfusion and (balloon models 2. 5-4. 0 mm only) the post-delivery expansion of balloon expandable stents.