PMA
P130021: MEDTRONIC COREVALVE SYSTEM
FDA PMA · Aortic valve, prosthesis, percutaneously delivered · Medtronic, Inc.
Key facts
| PMA number | P130021 |
|---|---|
| Trade name | MEDTRONIC COREVALVE SYSTEM |
| Generic name | Aortic valve, prosthesis, percutaneously delivered |
| Applicant | Medtronic, Inc. |
| Owner/operator | Medtronic, Inc. |
| Product code | NPT |
| Approval date | Jan 17, 2014 |
| Docket number | 14M-0166 |
| Notice date | Feb 4, 2014 |
| Establishment registration | 3001504994 |
| FEI number | 3001504994 |
At a glance
- 100–999 Supplements
- Aug 10, 2026 Latest supplement decision
- No Withdrawn
- Yes 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: