PMA
P240035: ETHIZIA
FDA PMA · Agent, absorbable hemostatic, collagen with polymeric additives · ETHICON, Inc.
Key facts
| PMA number | P240035 |
|---|---|
| Trade name | ETHIZIA |
| Generic name | Agent, absorbable hemostatic, collagen with polymeric additives |
| Applicant | ETHICON, Inc. |
| Owner/operator | ETHICON INC. |
| Product code | SGV |
| Approval date | Dec 15, 2025 |
| Docket number | 25M-7110 |
| Notice date | Dec 16, 2025 |
| Establishment registration | 2210968 |
| FEI number | 2210968 |
At a glance
- 1–9 Supplements
- Aug 27, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: