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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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FDA Advice Email, February 16, 2012 - Isoplate Solution

From:                    Valencia, Iliana

Sent:                      Thursday, February 16, 2012 3:05 PM
To:                         'Rebecca.Stolarick@bbraun.com'
Subject:                 BN090067 FDA Advice
Dear Ms. Stolarick,
 
We are in the process of reviewing your NDA submission. At this point in the review cycle, FDA is providing the following advice:
 
Please submit the 510(k) submission for Trima Accel system for the collection of hyperconcentrated platelets. 
 
Please note that the NDA approval is dependent on 510(k) clearance of Trima Accel system for the collection of hyperconcentrated platelets.
 
Sincerely,
 
Iliana Valencia, M.S.
Acting Chief, RPM Branch
Division of Blood Applications/ Office of Blood Research and Review
FDA / Center for Biologics Evaluation and Research
1401 Rockville Pike, Rockville, MD 20852 / WOC1; RM559N
O 301-827-6161 / F 301.827.2857 / iliana.valencia@fda.hhs.gov
"Whether you think you can or whether you think you can't, you're right." Henry Ford
 
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