Data / Medical devices / United Kingdom / JenaValve Production Limited
JenaValve Production Limited: FDA-registered device maker in Swillington Leeds, United Kingdom, 1 PMA approval
JenaValve Production Limited is registered with the FDA (registration 3011894841) in Swillington Leeds, United Kingdom. It lists 1 device type. The FDA files 1 PMA approval under its listings, the newest dated March 17, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011894841
- Address
- Unit 9A Astley Way, Swillington Leeds, United Kingdom, LS26 8XT
- Owner or operator
- JenaValve Technology, Inc. (10051384)
- Roles
- Manufacturer
- First device listed
- March 9, 2016
- Registered through
- 2026
- Brand names listed
- JenaValve, JenaValve Trilogy Transcatheter Heart Valve System, Trilogy Delivery Catheter, Trilogy Introducer Sheath, Trilogy Loading Tools, Trilogy Transcatheter Heart Valve (THV)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Aortic Valve, Prosthesis, Percutaneously Delivered | NPT | 3 | Manufacturer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| March 17, 2026 | P250024 | Trilogy Transcatheter Heart Valve System | NPT | 5 | October 13, 2026 | accessdata.fda.gov |
Compare with other makers
Updated October 13, 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.