|Trade Name||PTCA CATHETERS (MAVERICK2/MAVERICK/MAVERICK XL/QUANTUM/MAVERICK/APEX)|
|Classification Name||catheters, transluminal coronary angioplasty, percutaneous|
|Applicant||BOSTON SCIENTIFIC CORPORATION|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Reduction of in-process destructive testing and associated measurements performed on the balloon components of the devices during the balloon molding operation.