Archived Content

The content on this page is provided for reference purposes only. This content has not been altered or updated since it was archived.

Vaccines, Blood & Biologics

FDA Advice Email, February 16, 2012 - Isoplate Solution

From:                    Valencia, Iliana

Sent:                      Thursday, February 16, 2012 3:05 PM
To:                         ''
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.
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 /
"Whether you think you can or whether you think you can't, you're right." Henry Ford
THIS MESSAGE IS INTENDED ONLY FOR THE USE OF THE PARTY TO WHOM IT IS ADDRESSED AND MAY CONTAIN INFORMATION THAT IS PRIVILEGED, CONFIDENTIAL, AND PROTECTED FROM DISCLOSURE UNDER LAW. If you are not the addressee, or a person authorized to deliver the document to the addressee, you are hereby notified that any review, disclosure, dissemination, copying, or other action based on the content of this communication is not authorized. If you have received this document in error, please notify the sender immediately by e-mail or phone.

Page Last Updated: 04/03/2013
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English