Information Request Email, September 14, 2012 - EVARREST

Tilghman, Tracy

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From:                                Tilghman, Tracy

Sent:                                 Friday, September 14, 2012 4:52 PM

To:                                    'Chung, Jessica [ETHUS]'

Cc:                                    Shields, Mark

Subject:                             Reference BL# 125392/0 - Information Request

 

Importance:                       High

 

 

Dear Ms. Chung,

 

We are reviewing your March 30, 2012 resubmission for Fibrin Pad to be used as an adjunct to hemostasis for soft tissue bleeding during retroperitoneal, intra-abdominal, pelvic, and (non-cardiac) thoracic surgery when control of bleeding by standard surgical methods of hemostasis is ineffective or impractical.  We request the following post marketing commitments from Ethicon, Inc. below:

 

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Please respond to this request as an amendment to this file, referencing the date of this request by September 19, 2012.

 

The review of this submission is ongoing and issues may be added, expanded upon, or modified as we continue to review this submission.

 

The resubmission action due date for this file is September 29, 2012. If you have any questions, please contact me at (301) 827-9427.        

Sincerely,

Tracy Tilghman, MPH

Lieutenant, United States Public Health Service

Regulatory Project Manager

 

U.S. Food & Drug Administration

CBER/OBRR/DBA/RPMB

1401 Rockville Pike

RM 556N, HFM-380

Rockville, MD  20852

Phone: 301-827-9427

Email: tracy.tilghman@fda.hhs.gov

 

 

 

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