PMA
P220012: Aurora EV-ICD System
FDA PMA · Implantable cardioverter defibrillator (non-CRT) · Medtronic, Inc.
Key facts
| PMA number | P220012 |
|---|---|
| Trade name | Aurora EV-ICD System |
| Generic name | Implantable cardioverter defibrillator (non-CRT) |
| Applicant | Medtronic, Inc. |
| Owner/operator | Medtronic, Inc. |
| Product code | LWS |
| Approval date | Oct 20, 2023 |
| Docket number | 23M-4553 |
| Notice date | Oct 27, 2023 |
| Establishment registration | 2182208 |
| FEI number | 2182208 |
At a glance
- 10–99 Supplements
- Jul 31, 2026 Latest supplement decision
- No Withdrawn
- Yes 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: