Helistat® Absorbable Collagen Hemostatic Agent and Helitene® Absorbable Collagen Hemostatic Agent Fibrillar Form
FDA premarket approval P850010/S109 · decided 2024-02-21
Approval details
- PMA number
- P850010
- Supplement
- S109
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Helistat® Absorbable Collagen Hemostatic Agent and Helitene® Absorbable Collagen Hemostatic Agent Fibrillar Form
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Integra LifeSciences Corporation
- Date received
- 2024-01-22
- Decision date
- 2024-02-21
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Plainsboro, NJ
- Statement
- qualification of a new external Process Challenge Device, and an update to the quantity of internal and external Process Challenge Devices used in Performance Qualification and routine monitoring of the ethylene oxide sterilization cycle
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