Data / Medical devices / Aortic Valve, Prosthesis, Percutaneously Delivered
Aortic Valve, Prosthesis, Percutaneously Delivered (NPT): 14 FDA-registered makers in 6 countries
14 establishments in 6 countries are registered with the FDA to make Aortic Valve, Prosthesis, Percutaneously Delivered (product code NPT, Class 3). 13 of them have a 510(k) clearance or PMA approval on file and 5 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 15 recall events (5 Class I). FDA data exported November 2, 2026.
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- Product code
- NPT
- Device class
- 3
- Medical specialty
- Unknown
- Implant
- Yes
- Life sustaining or supporting
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 7 |
| Costa Rica | 2 |
| Ireland | 2 |
| Singapore | 1 |
| United Kingdom | 1 |
| Mexico | 1 |
Makers of Aortic Valve, Prosthesis, Percutaneously Delivered
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| EDWARDS LIFESCIENCES (SINGAPORE) Pte Ltd | Changi South East, Singapore | Manufacturer | 0 | 2 | 0 | 0 | api.fda.gov | |
| 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 | |
| Abbott Medical Costa Rica Limitada (Structural Heart) | El Coyol Alajuela, Costa Rica | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Edwards Lifesciences | Guadalupe Cartago, Costa Rica | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Edwards Lifesciences Ireland Limited | Limerick Munster, Ireland | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Jenavalve Technology, Inc. | Irvine, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 1 | 1 | 0 | api.fda.gov | |
| JenaValve Production Limited | Swillington Leeds, United Kingdom | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Medtronic Ireland | GALWAY Galway(County), Ireland | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Medtronic Heart Valves Division | Santa Ana, CA, United States | Specification developer | 0 | 1 | 4 | 1 | api.fda.gov | |
| Medtronic Mexico S. de R.L. de CV | Tijuana Baja California, Mexico | Manufacturer | 0 | 1 | 0 | 0 | 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 2, 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.