PMA
P870038: STARR-EDWARDS SILASTIC BALL HEART VALVE PROSTHESES
FDA PMA · HEART-VALVE, MECHANICAL · Edwards Lifesciences, LLC
Key facts
| PMA number | P870038 |
|---|---|
| Trade name | STARR-EDWARDS SILASTIC BALL HEART VALVE PROSTHESES |
| Generic name | HEART-VALVE, MECHANICAL |
| Applicant | Edwards Lifesciences, LLC |
| Owner/operator | Edwards Lifesciences LLC |
| Product code | LWQ |
| Approval date | Sep 27, 1991 |
| Docket number | 91M-0420 |
| Notice date | Nov 14, 1991 |
| Establishment registration | 2015691 |
| FEI number | 2015691 |
At a glance
- 1–9 Supplements
- Jan 29, 2007 Latest supplement decision
- Yes Withdrawn
- No Summary of safety and effectiveness on file
- None 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: