PMA supplement
P000037 S001: ON-X PROSTHETIC HEART VALVE
FDA PMA supplement · Panel Track · On-X Life Technologies, Inc.
Key facts
| Original PMA | P000037 |
|---|---|
| Supplement number | S001 |
| Supplement type | Panel Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | ON-X PROSTHETIC HEART VALVE |
| Generic name | HEART-VALVE, MECHANICAL |
| Applicant | On-X Life Technologies, Inc. |
| Product code | LWQ |
| Received date | Sep 7, 2001 |
| Decision date | Mar 6, 2002 |
| Docket number | 02M-0255 |
| Notice date | Jun 5, 2002 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: