ETHIZIA
FDA premarket approval P240035 · decided 2025-12-15
Approval details
- PMA number
- P240035
- Trade name
- ETHIZIA
- Generic name
- Agent, absorbable hemostatic, collagen with polymeric additives
- Applicant
- ETHICON, Inc.
- Date received
- 2024-10-17
- Decision date
- 2025-12-15
- Days to decision
- 424 days
- Decision code
- APPR
- Product code
- SGV
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Raritan, NJ
- Statement
- Approval for ETHIZIA indicated for use in adult patients with a body weight of greater than or equal to 25kg as an adjunct to hemostasis in open liver surgery for minimal, mild, or moderate bleeding sites when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical.
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