STN: BL 125392
Proper Name: Fibrin Sealant Patch – Human Fibrinogen and Human Thrombin
Trade Name: EVARREST
Manufacture: Omrix Biopharmaceuticals, Ltd, Distributed by: Ethicon, Inc.
- Indicated for use with manual compression as an adjunct to hemostasis in adult patients undergoing surgery, when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical.
October 7, 2016 Approval Letter - EVARREST(PDF - 110KB)
To expand the clinical indication of EVARREST.
September 26, 2016 Summary Basis for Regulatory Action - EVARREST(PDF - 76KB) March 30, 2015 Summary Basis for Regulatory Action - EVARREST(PDF - 93KB) March 26, 2015 Approval Letter - EVARREST(PDF - 41KB) Summary Basis for Regulatory Action, November 2012 - EVARREST(PDF - 479KB) December 5, 2012 Approval Letter - EVARREST Approval History, Letters, Review, and Related Documents - EVARREST[ARCHIVED]