PMA
P220004: PALMAZ MULLINS XD Pulmonary Stent
FDA PMA · Pulmonary stent · Cordis US Corp
Key facts
| PMA number | P220004 |
|---|---|
| Trade name | PALMAZ MULLINS XD Pulmonary Stent |
| Generic name | Pulmonary stent |
| Applicant | Cordis US Corp |
| Owner/operator | Cordis US Corp. |
| Product code | QWC |
| Approval date | Jul 21, 2023 |
| Docket number | 23M-3903 |
| Notice date | Sep 18, 2023 |
| Establishment registration | 1016427 |
| FEI number | 1016427 |
At a glance
- 1–9 Supplements
- Sep 5, 2024 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- No Withdrawn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: