|Trade Name||GRUNTZIG DILACA CORONARY ARTERY BALLOON DILATATION CATHETER|
|Classification Name||catheters, transluminal coronary angioplasty, percutaneous|
|Generic Name||catheters, transluminal coronary angioplasty, percutaneous|
|Supplement Type||135 review track for 30-day notice|
|Supplement Reason|| process change - manufacturer/sterilizer/packager/supplier|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval to: 1) introduce an automated inflation device, replacing the current manual process, to inflate ptca balloons prior to in-process functional testing; and 2) reduce the number of samples which are taken to monitor particulate levels in nitrogen gas and compressed air.