PMA
P000037: ON-X (R) PROSTHETIC HEART VALVE, MODEL ONXA
FDA PMA · HEART-VALVE, MECHANICAL · On-X Life Technologies, Inc.
Key facts
| PMA number | P000037 |
|---|---|
| Trade name | ON-X (R) PROSTHETIC HEART VALVE, MODEL ONXA |
| Generic name | HEART-VALVE, MECHANICAL |
| Applicant | On-X Life Technologies, Inc. |
| Owner/operator | On-X Life Technologies, Inc |
| Product code | LWQ |
| Approval date | May 30, 2001 |
| Docket number | 01M-0270 |
| Notice date | Jun 19, 2001 |
| Establishment registration | 1649833 |
| FEI number | 3001584317 |
At a glance
- 10–99 Supplements
- Aug 4, 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- No Withdrawn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: