|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||real-time process|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval to extend the product line of the scimed(r) nc ranger(tm) ptca catheter to include a 9 mm length balloon with diameters ranger from 2. 5 mm to 4. 0 mm in 0. 25 mm increments. The device, as modified, will be marketed under the trade name scimed(r) 9 mm nc ranger(tm) ptca catheter 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.