|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||ANGIOJET RHEOLOYTIC THROMBECTOMY SYSTEM|
|Classification Name||catheter, coronary, atherectomy|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for changing the packaging tray material for the angiojet ultra xmi, ultra spiroflex, and ultra spiroflex vg thrombectomy sets from petg to petg denest, as well as changing the manufacturing of these packaging trays from perfecseal to brookdale.