STN: BL 125640
Proper Name: FIBRIN SEALANT (Human)
Trade Name:  None
Manufacture: Instituto Grifols, S.A.
Indication: 

• Indicated for use as an adjunct to hemostasis for mild to moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical.  Fibrin Sealant (Human) is effective in heparinized patients.

Product Information

• Package Insert - FIBRIN SEALANT (Human)
• Demographic Subgroup Information - FIBRIN SEALANT (Human)
  Refer to Section 1.1 of the Clinical Review Memo for information about participation in the clinical trials and any analysis of demographic subgroup outcomes that is notable.

Supporting Documents

• November 1, 2017 Summary Basis for Regulatory Action - Fibrin Sealant (Human)
• November 1, 2017 Approval Letter - Fibrin Sealant (Human)
• Approval History, Letters, Reviews, and Related Documents - FIBRIN SEALANT (Human)