|Trade Name||ANGIOSCULPT PTCA SCORING BALLOON CATHETER,RAPID EXCHANGE (RX0|
|Classification Name||catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring|
|Generic Name||catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring|
|Supplement Type||30-day notice|
|Supplement Reason|| process change - manufacturer/sterilizer/packager/supplier|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Manufacturing change to include a new part number for the device and the purchase of the oem rapid exchange balloon catheter manufactured by a qualified supplier.