PMA
P970020: MULTI-LINK ULTRA/ ZETA CORONARY STENT SYSTEMS
FDA PMA · STENT, CORONARY · Abbott Vascular, Inc.
Key facts
| PMA number | P970020 |
|---|---|
| Trade name | MULTI-LINK ULTRA/ ZETA CORONARY STENT SYSTEMS |
| Generic name | STENT, CORONARY |
| Applicant | Abbott Vascular, Inc. |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | MAF |
| Approval date | Oct 2, 1997 |
| Docket number | 98M-0971 |
| Establishment registration | 2024168 |
| FEI number | 2024168 |
At a glance
- 10–99 Supplements
- Sep 7, 2022 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- 10–99 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: