Data / Medical devices / Aortic Valve, Prosthesis, Percutaneously Delivered / United States
FDA-registered makers of Aortic Valve, Prosthesis, Percutaneously Delivered in the United States: 7 establishments
7 establishments in the United States are registered with the FDA to make Aortic Valve, Prosthesis, Percutaneously Delivered (product code NPT). 6 have a 510(k) clearance or PMA approval on file and 5 have a recall event. FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Device
- Aortic Valve, Prosthesis, Percutaneously Delivered
- Product code
- NPT
- Country
- United States
Makers of Aortic Valve, Prosthesis, Percutaneously Delivered in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Edwards Lifesciences LLC | Irvine, CA, United States | Manufacturer, Specification developer | 0 | 2 | 2 | 1 | api.fda.gov | |
| Edwards Lifesciences LLC | Draper, UT, United States | Manufacturer | 0 | 2 | 4 | 1 | api.fda.gov | |
| Abbott Medical | Saint Paul, MN, United States | Manufacturer, Manufacturer for export | 0 | 1 | 1 | 0 | api.fda.gov | |
| Jenavalve Technology, Inc. | Irvine, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 1 | 1 | 0 | api.fda.gov | |
| Medtronic Heart Valves Division | Santa Ana, CA, United States | Specification developer | 0 | 1 | 4 | 1 | api.fda.gov | |
| St. Jude Medical | Roseville, MN, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Primo Medical Group, Inc | W Bridgewater, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.