PMA
P880003: CORDIS PTCA DILATATION CATHETER
FDA PMA · Catheters, transluminal coronary angioplasty, percutaneous · Cordis Corp.
Key facts
| PMA number | P880003 |
|---|---|
| Trade name | CORDIS PTCA DILATATION CATHETER |
| Generic name | Catheters, transluminal coronary angioplasty, percutaneous |
| Applicant | Cordis Corp. |
| Owner/operator | Cordis US Corp. |
| Product code | LOX |
| Approval date | Oct 28, 1988 |
| Docket number | 88M-0383 |
| Notice date | Feb 7, 1989 |
| Establishment registration | 1016427 |
| FEI number | 1016427 |
At a glance
- 10–99 Supplements
- Jan 20, 2010 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- 100–999 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: