PMA
P990036: CORDIS CHECKMATE(TM) SYSTEM
FDA PMA · Intravascular radiation delivery system · Cordis Corp.
Key facts
| PMA number | P990036 |
|---|---|
| Trade name | CORDIS CHECKMATE(TM) SYSTEM |
| Generic name | Intravascular radiation delivery system |
| Applicant | Cordis Corp. |
| Owner/operator | Cordis US Corp. |
| Product code | MOU |
| Approval date | Nov 3, 2000 |
| Docket number | 00M-1650 |
| Notice date | Dec 13, 2000 |
| Establishment registration | 1016427 |
| FEI number | 1016427 |
At a glance
- 1–9 Supplements
- Jul 25, 2002 Latest supplement decision
- Yes Withdrawn
- Yes Summary of safety and effectiveness on file
- None 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: