Data / Medical devices / United States / Jenavalve Technology, Inc.
Jenavalve Technology, Inc.: FDA-registered device maker in Irvine, CA, United States, 1 PMA approval
Jenavalve Technology, Inc. is registered with the FDA (registration 3012148004) in Irvine, CA, United States. It lists 1 device type. The FDA files 1 PMA approval under its listings, the newest dated March 17, 2026. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 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.
- FDA registration number
- 3012148004
- Address
- 4 Cromwell, Irvine, CA, United States, 92618
- Owner or operator
- JenaValve Technology, Inc. (10051384)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- 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 | Complaint file establishment, Manufacturer, Specification developer | 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 |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 31, 2026 | 99697 | Class II | Ongoing | JenaValve Trilogy Delivery Catheter, Size 23MM REF: TRILOGY-DC-S | Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device. | 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.