PMA
P910030: GIANTURCO-ROUBIN CORONARY FLEX-STENT(TM)
FDA PMA · STENT, CORONARY · Cook, Inc.
Key facts
| PMA number | P910030 |
|---|---|
| Trade name | GIANTURCO-ROUBIN CORONARY FLEX-STENT(TM) |
| Generic name | STENT, CORONARY |
| Applicant | Cook, Inc. |
| Owner/operator | COOK, INC. |
| Product code | MAF |
| Approval date | Feb 8, 1993 |
| Docket number | 93M-0212 |
| Notice date | Jul 22, 1993 |
| Establishment registration | 1820334 |
| FEI number | 1820334 |
At a glance
- 1–9 Supplements
- Feb 13, 2002 Latest supplement decision
- Yes Withdrawn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: