PMA
P100030: ARTERX SURGICAL SEALANT
FDA PMA · Sealant, polymerizing · Baxter Healthcare Corporation
Key facts
| PMA number | P100030 |
|---|---|
| Trade name | ARTERX SURGICAL SEALANT |
| Generic name | Sealant, polymerizing |
| Applicant | Baxter Healthcare Corporation |
| Owner/operator | BAXTER HEALTHCARE CORPORATION |
| Product code | NBE |
| Approval date | Mar 1, 2013 |
| Docket number | 13M-0281 |
| Notice date | Mar 14, 2013 |
| Establishment registration | 1417572 |
| FEI number | 1417572 |
At a glance
- 10–99 Supplements
- Jul 10, 2025 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 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: