PMA supplement
P000037 S048: ON-X (R) PROSTHETIC HEART VALVE, ON-X CONFORM-X AORTIC PROSTHETIC HEART VALVE, ON-X AORTIC PROSTHETIC HEART VALVE WITH A
FDA PMA supplement · Normal 180 Day Track No User Fee · On-X Life Technologies, Inc.
Key facts
| Original PMA | P000037 |
|---|---|
| Supplement number | S048 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Postapproval Study Protocol - OSB |
| Trade name | ON-X (R) PROSTHETIC HEART VALVE, ON-X CONFORM-X AORTIC PROSTHETIC HEART VALVE, ON-X AORTIC PROSTHETIC HEART VALVE WITH A |
| Generic name | HEART-VALVE, MECHANICAL |
| Applicant | On-X Life Technologies, Inc. |
| Product code | LWQ |
| Received date | Dec 9, 2016 |
| Decision date | Feb 7, 2017 |
At a glance
- No Expedited review granted
- No Approval order on file
- No 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: