Helistat and Helitene Absorbable Collagen Hemostatic Agents
FDA premarket approval P850010/S098 · decided 2021-11-13
Approval details
- PMA number
- P850010
- Supplement
- S098
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Helistat and Helitene Absorbable Collagen Hemostatic Agents
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Integra LifeSciences Corporation
- Date received
- 2021-05-24
- Decision date
- 2021-11-13
- Days to decision
- 173 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Plainsboro, NJ
- Statement
- Approval for the qualification of an additional abattoir (harvesting facility) for New Zealand sourced bovine tendon.
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