|Trade Name||ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM|
|Classification Name||catheter, coronary, atherectomy|
|Applicant||BAYER MEDICAL CARE INC.|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: sterilization|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Modification to change the current manual method of quantifying the amount of bacterial endotoxins present to using an automated instrument. Additionally, the number of samples collected will be changed to three samples per sterile load, tested on a pooled basis and with explicit extraction instructions.