|Trade Name||WALLSTENT (ILIAC, TIPS, VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM|
|Classification Name||shunt, portosystemic, endoprosthesis|
|Generic Name||endoprosthesis with unistep plus delivery system|
|Applicant||BOSTON SCIENTIFIC SCIMED, INC.|
|Supplement Type||30-day notice|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Changes in the manufacturing process: 1) introduction of a tip tug test on-line at the final inspection step, 2) introduction of an automated auto-feed system to the existing swager unit, and 3) introduction of semi-automated manufacturing side arm connectors as an alternative to the manual manufacturing process.