STN: BL 125392
Proper Name: Fibrin Sealant Patch – Human Fibrinogen and Human Thrombin
Trade Name: EVARREST
Manufacture: Omrix Biopharmaceuticals, Ltd, Distributed by: Ethicon, Inc.
- For use with manual compression as an adjunct to hemostasis for soft tissue bleeding during open retroperitoneal, intra-abdominal, pelvic, and non-cardiac thoracic surgery when control of bleeding by standard surgical methods of hemostasis (e.g., suture, ligature, cautery) is ineffective or impractical.
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]