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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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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