ETHIZIA Hemostatic Patch
FDA premarket approval P240035/S001 · decided 2026-01-22
Approval details
- PMA number
- P240035
- Supplement
- S001
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ETHIZIA Hemostatic Patch
- Generic name
- Agent, absorbable hemostatic, collagen with polymeric additives
- Applicant
- ETHICON, Inc.
- Date received
- 2025-12-18
- Decision date
- 2026-01-22
- Days to decision
- 35 days
- Decision code
- OK30
- Product code
- SGV
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Raritan, NJ
- Statement
- a raw material supplier change for a gelatin carrier component in a hemostatic patch
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