PMA
P900043: PALMAZ-SCHATZ(TM) BALLOON EXPANDABLE STENT
FDA PMA · STENT, CORONARY · Cordis Corp.
Key facts
| PMA number | P900043 |
|---|---|
| Trade name | PALMAZ-SCHATZ(TM) BALLOON EXPANDABLE STENT |
| Generic name | STENT, CORONARY |
| Applicant | Cordis Corp. |
| Owner/operator | Cordis US Corp. |
| Product code | MAF |
| Approval date | Aug 2, 1994 |
| Docket number | 97M-0166 |
| Notice date | Jul 10, 1997 |
| Establishment registration | 1016427 |
| FEI number | 1016427 |
At a glance
- 10–99 Supplements
- Mar 4, 2004 Latest supplement decision
- Yes Withdrawn
- No 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: