PMA
P830039: OMNISCEINCE PROSTHETIC CARDIAC VALVE
FDA PMA · HEART-VALVE, MECHANICAL · Medical Cv, Inc.
Key facts
| PMA number | P830039 |
|---|---|
| Trade name | OMNISCEINCE PROSTHETIC CARDIAC VALVE |
| Generic name | HEART-VALVE, MECHANICAL |
| Applicant | Medical Cv, Inc. |
| Product code | LWQ |
| Approval date | May 3, 1985 |
| Docket number | 85M-0386 |
| Notice date | Sep 11, 1985 |
At a glance
- 1–9 Supplements
- Oct 29, 2002 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- Yes Withdrawn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: