PMA
P240023: WRAPSODY® Cell-Impermeable Endoprosthesis
FDA PMA · System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment · Merit Medical Systems, Inc.
Key facts
| PMA number | P240023 |
|---|---|
| Trade name | WRAPSODY® Cell-Impermeable Endoprosthesis |
| Generic name | System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment |
| Applicant | Merit Medical Systems, Inc. |
| Owner/operator | Merit Medical Systems, Inc. |
| Product code | PFV |
| Approval date | Dec 19, 2024 |
| Docket number | 24M-5932 |
| Notice date | Jan 10, 2025 |
| Establishment registration | 1721504 |
| FEI number | 1721504 |
At a glance
- 1–9 Supplements
- Jun 11, 2026 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- No Withdrawn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: