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Resubmission Acknowledgement Letter - SOLX® System



 
DEPARTMENT OF HEALTH & HUMAN SERVICES                                            
         Public Health Service
 


                                                                                 
                                           Food and Drug Administration

1401 Rockville Pike

Rockville, MD 20852-1448

 

Our Reference:  NDA BN110059

Hemerus Medical, LLC
Attention:  Ms. Lynn Jensen
5000 Township Parkway 
Saint Paul, MN  55110

Dear Ms. Jensen:

We acknowledge receipt on February 27, 2013, of your February 26, 2013, 
resubmission to your new drug application submitted under Section 505(b) of the 
Federal Food, Drug, and Cosmetic Act, for SOLX® System, LEUKOSEP® HWB-600-XL 
Leukocyte Reduction Filtration System for Whole Blood with CPD Anticoagulant and 
SOLX® Additive. 

We consider this a complete, class 1 response to our August 31, 2012, action 
letter.  Therefore, the goal date is April 28, 2013.

If you have any questions, please call Sonday L. Kelly, MS, RAC, Regulatory 
Project Manager, at (301) 827-6162.

Sincerely,
 

/s/

Iliana Valencia, MS
Chief, Regulatory Project Management Branch
Division of Blood Applications
Office of Blood Research and Review
Center for Biologics 
Evaluation and Research
 

    
 