2006N-0362
  

  
 General and Plastic Surgery Devices; Reclassification of the Absorbable Hemostatic Device

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC3
  



  

  
Submitter : 
  

  
Mr. Ronald Peterson
  

  
Date & Time: 
  

  
06/07/2007 08:06:37
  



  

  
Organization : 
  

  
Z-Medica Corporation
  



  

  
Category : 
  

  
Device Industry
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 Z-Medica Corporation (Z-Medica), a medical products company focused on innovative hemostatic nanotechnologies, hereby submits comments regarding the above referenced draft document.  Z-Medica Corporation is supportive of the FDA's proposal that advocates reclassification of absorbable hemostats from Class III to Class II Special Controls and believes that the special controls in the draft document will provide reasonable assurances of safety and efficacy for this device.