PMA
P210025: SurVeil Drug-Coated Balloon
FDA PMA · Drug-Eluting Peripheral Transluminal Angioplasty Catheter · Surmodics,Inc.
Key facts
| PMA number | P210025 |
|---|---|
| Trade name | SurVeil Drug-Coated Balloon |
| Generic name | Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
| Applicant | Surmodics,Inc. |
| Owner/operator | SURMODICS, INC. |
| Product code | ONU |
| Approval date | Jun 16, 2023 |
| Docket number | 23M-3051 |
| Notice date | Jul 28, 2023 |
| Establishment registration | 3001374820 |
| FEI number | 3001374820 |
At a glance
- 1–9 Supplements
- Jun 6, 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- No Withdrawn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: