PMA
P180029: LOTUS Edge Valve System
FDA PMA · Aortic valve, prosthesis, percutaneously delivered · Boston Scientific Corporation
Key facts
| PMA number | P180029 |
|---|---|
| Trade name | LOTUS Edge Valve System |
| Generic name | Aortic valve, prosthesis, percutaneously delivered |
| Applicant | Boston Scientific Corporation |
| Owner/operator | Boston Scientific Corporation |
| Product code | NPT |
| Approval date | Apr 23, 2019 |
| Docket number | 19M-1998 |
| Notice date | Apr 26, 2019 |
| Establishment registration | 2134265 |
| FEI number | 3002095335 |
At a glance
- 10–99 Supplements
- Mar 30, 2021 Latest supplement decision
- Yes Withdrawn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: