- Device
- Helistat Absorbable Collagen Hemostatic Sponge/OraFOAM Absorbable Collagen Hemostatic Sponge
- Applicant
- Integra LifeSciences Corporation
- PMA number
- P850010
- Supplement
- S082
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2019-03-13
- Decision code
- APPR
- Date received
- 2018-09-14
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for an additional trade name, OraFOAM, for the Helistat® Absorbable Collagen Hemostatic Sponge.