PMA
P210036: PerClot® Polysaccharide Hemostatic System
FDA PMA · Agent, absorbable hemostatic, non-collagen based · Baxter Healthcare Corporation
Key facts
| PMA number | P210036 |
|---|---|
| Trade name | PerClot® Polysaccharide Hemostatic System |
| Generic name | Agent, absorbable hemostatic, non-collagen based |
| Applicant | Baxter Healthcare Corporation |
| Owner/operator | BAXTER HEALTHCARE CORPORATION |
| Product code | LMG |
| Approval date | May 19, 2023 |
| Establishment registration | 1416980 |
| FEI number | 1416980 |
At a glance
- 1–9 Supplements
- Aug 7, 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- No Withdrawn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: