PMA
P000007: EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS MODEL 2500P
FDA PMA · Replacement Heart-valve · Edwards Lifesciences, LLC
Key facts
| PMA number | P000007 |
|---|---|
| Trade name | EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS MODEL 2500P |
| Generic name | Replacement Heart-valve |
| Applicant | Edwards Lifesciences, LLC |
| Owner/operator | Edwards Lifesciences LLC |
| Product code | DYE |
| Approval date | Feb 27, 2001 |
| Docket number | 01M-0381 |
| Notice date | Sep 5, 2001 |
| Establishment registration | 2015691 |
| FEI number | 2015691 |
At a glance
- 10–99 Supplements
- May 20, 2014 Latest supplement decision
- Yes Withdrawn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: