|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||real-time process|
|Supplement Reason|| change design/components/specifications - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for: 1)the addition of balloon diameters of 4. 5 mm and 5. 0 mm to the currently approved 15 mm length of the nc rebel(tm) ptca catheter, and 2) an additional balloon length of 30 mm with balloon diameters of 2. 5 mm up to 4. 0 mm in 1/4 mm increments for the nc rebel(tm) ptca catheter.