|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.|
|Trade Name||ZENITH AAA ENDOVASCULAR GRAFT WITH H&L-B ONE SHOT INTRODUCTION SYSTEM|
|Classification Name||system, endovascular graft, aortic aneurysm treatment|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Allowing the internal and external threads of the dilator tip (a component of the h&l-b one-shot introduction system) to be machined by an outside vendor.