Helistat Absorbable Collagen Hemostatic Agent and Helitene Absorbable Collagen Hemostatic Agent Fibrillar Form
FDA premarket approval P850010/S078 · decided 2018-06-28
Approval details
- PMA number
- P850010
- Supplement
- S078
- Supplement type
- 135 Review Track For 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
- 2017-12-22
- Decision date
- 2018-06-28
- Days to decision
- 188 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Plainsboro, NJ
- Statement
- Approval for verification of a temporary ethylene oxide sterilization cycle for the collagen products manufactured and released from the Integra Neurosciences, Anasco, Puerto Rico facility.
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