|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Classification Name||occluder, internal vessel, temporary|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: packaging|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Changes to the packaging configurations by reducing the number of tyvek pouched cannulae per sales carton.