PMA
P150048: EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS (MODEL 11000A) and EDWARDS INSPIRIS RESILIA AORTIC VALVE (MODEL 11500)
FDA PMA · Heart-valve, non-allograft tissue · Edwards Lifesciences, LLC
Key facts
| PMA number | P150048 |
|---|---|
| Trade name | EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS (MODEL 11000A) and EDWARDS INSPIRIS RESILIA AORTIC VALVE (MODEL 11500) |
| Generic name | Heart-valve, non-allograft tissue |
| Applicant | Edwards Lifesciences, LLC |
| Owner/operator | Edwards Lifesciences LLC |
| Product code | LWR |
| Approval date | Jun 29, 2017 |
| Docket number | 17M-3990 |
| Notice date | Jul 6, 2017 |
| Establishment registration | 2015691 |
| FEI number | 2015691 |
At a glance
- 10–99 Supplements
- Jul 29, 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- No Withdrawn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: