|Trade Name||SIMPSON CORONARY ATHEROCATH-GTO|
|Classification Name||catheter, coronary, atherectomy|
|Generic Name||catheter, coronary, atherectomy|
|Supplement Type||30-day notice|
|Supplement Reason|| process change - manufacturer/sterilizer/packager/supplier|
|Expedited Review Granted?|| No|
|Approval Order Statement |
The 30-day notice requested implementation of two additional on-line inspections to the current manufacturing process to provide added assurance that the manufacturing step for attaching the nose cone to the housing has been performed correctly.