PMA
P890017: PALMAZ BALLOON EXPANDABLE STENT
FDA PMA · STENT, RENAL · Cordis US Corporation
Key facts
| PMA number | P890017 |
|---|---|
| Trade name | PALMAZ BALLOON EXPANDABLE STENT |
| Generic name | STENT, RENAL |
| Applicant | Cordis US Corporation |
| Owner/operator | Cordis US Corp. |
| Product code | NIN |
| Approval date | Sep 27, 1991 |
| Docket number | 91M-0398 |
| Notice date | Nov 14, 1991 |
| Establishment registration | 1016427 |
| FEI number | 1016427 |
At a glance
- 10–99 Supplements
- Dec 20, 2022 Latest supplement decision
- No Withdrawn
- No 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: