|Trade Name||NC MAXXUM PTCA CATHETER|
|Classification Name||catheters, transluminal coronary angioplasty, percutaneous|
|Applicant||BOSTON SCIENTIFIC SCIMED, INC.|
|Supplement Type||135 review track for 30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for an improved process which will allow use of n-heptane for cleaning balloons and catheter shaft components prior to bonding.