|Trade Name||PTCA CATHETERS|
|Classification Name||catheters, transluminal coronary angioplasty, percutaneous|
|Applicant||BOSTON SCIENTIFIC CORPORATION|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: packaging|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Change to equipment used for sealing the pouches in which the finished devices are packaged.