Reclassification Issues:

 

1.                  Please discuss the proposed reclassification of the absorbable hemostatic agent and dressing.  Please also discuss what descriptive information and intended use should be included in the classification identification.

2.                  Please discuss the risks to health for the absorbable hemostatic agent and dressing.

3.                  Are there any other risks to health for these devices that have not been identified?