ETHIZIA Hemostatic Patch
FDA premarket approval P240035/S002 · decided 2026-06-25
Approval details
- PMA number
- P240035
- Supplement
- S002
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ETHIZIA Hemostatic Patch
- Generic name
- Agent, absorbable hemostatic, collagen with polymeric additives
- Applicant
- ETHICON, Inc.
- Date received
- 2025-12-29
- Decision date
- 2026-06-25
- Days to decision
- 178 days
- Decision code
- APPR
- Product code
- SGV
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Raritan, NJ
- Statement
- approval for the ETHIZIA Hemostatic Patch for expanding the indications to include minimally invasive surgical procedures on the liver.
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