ETHIZIA Hemostatic Patch
FDA premarket approval P240035/S003 · decided 2026-01-28
Approval details
- PMA number
- P240035
- Supplement
- S003
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- ETHIZIA Hemostatic Patch
- Generic name
- Agent, absorbable hemostatic, collagen with polymeric additives
- Applicant
- ETHICON, Inc.
- Date received
- 2025-12-31
- Decision date
- 2026-01-28
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- SGV
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Raritan, NJ
- Statement
- the protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P240035
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