|Trade Name||SCIMED PTCA CATHETERS|
|Classification Name||catheters, transluminal coronary angioplasty, percutaneous|
|Applicant||BOSTON SCIENTIFIC SCIMED, INC.|
|Supplement Type|| Special Supplement|
|Supplement Reason|| labeling change - instructions|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a labeling change that strengthens a warning statement included in the directions for use manual. Specifically, the labeling statement is being modified to expand the information provided regarding the affect of re-processing or re-sterilization. The change applies to all directions for use manuals of currently marketed ptca catheters approved under this pma.