|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||FLEXI-CUT DIRECTIONAL DEBULKING SYSTEM|
|Classification Name||catheter, coronary, atherectomy|
|Generic Name||catheter, coronary, atherectomy|
|Supplement Type||30-day notice|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Change to allow sterile product release based on demonstration of conformity to pre-defined sterilization parameters (parametric release) rather than release based on demonstrating no growth of biological indicators (conventional release).