|Trade Name||SCIMED(R) RANGER(TM) PERCUTANEOUS 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 - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a change from 1 to 2 marker bands for the 20 mm balloon length ranger(tm) ptca catheter and for a change that makes all ranger(tm) ptca catheter (20, 30, and 40 mm balloon lengths) marker band locations proximal and distal.