Helistat Absorbable Collagen Hemostatic Sponge/OraFOAM Absorbable Collagen Hemostatic Sponge
FDA premarket approval P850010/S082 · decided 2019-03-13
Approval details
- PMA number
- P850010
- Supplement
- S082
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Helistat Absorbable Collagen Hemostatic Sponge/OraFOAM Absorbable Collagen Hemostatic Sponge
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Integra LifeSciences Corporation
- Date received
- 2018-09-14
- Decision date
- 2019-03-13
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Plainsboro, NJ
- Statement
- Approval for an additional trade name, OraFOAM, for the Helistat® Absorbable Collagen Hemostatic Sponge.
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