JenaValve Technology, Inc.: FDA clearances and approvals
JenaValve Technology, Inc. has 0 FDA 510(k) clearances, plus 1 PMA decision, across 1 product code in 1 review panel. It is the industry lead sponsor of 5 device clinical trials on ClinicalTrials.gov.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NPT | Aortic Valve, Prosthesis, Percutaneously Delivered | 1 | 0 |
Review panels
- Cardiovascular (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P250024 | PMA | Trilogy Transcatheter Heart Valve System | 2026-03-17 |
Recalls
openFDA lists no recalls under a recalling firm named JenaValve Technology, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
JenaValve Technology, Inc. is the industry lead sponsor of 5 device studies on ClinicalTrials.gov (4 active or recruiting). Most recent:
- NCT06608823: ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™ (Recruiting, started 2025-06-18)
- NCT06594705: The JenaValve ALIGN-AR LVAD Registry (Recruiting, started 2024-12-09)
- NCT04415047: The JenaValve ALIGN-AR Pivotal Trial (Active not recruiting, started 2020-05-22)
- NCT02732704: THE ALIGN-AR EFS TRIAL: JenaValve Pericardial TAVR Aortic Regurgitation Study (Active not recruiting, started 2018-04-20)
- NCT01598844: JUPITER Study: Transapical Aortic Valve Implantation for Aortic Regurgitation (Completed, started 2012-05-30)
Frequently asked questions
How many FDA 510(k) clearances does JenaValve Technology, Inc. have?
JenaValve Technology, Inc. has 0 FDA 510(k) clearances, plus 1 PMA decision, across 1 product code in 1 review panel.
What devices does JenaValve Technology, Inc. make?
Its most frequent FDA product codes are NPT (Aortic Valve, Prosthesis, Percutaneously Delivered, 1).
Has JenaValve Technology, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching JenaValve Technology, Inc. Related entities may recall under other names.
Next steps
- See all 0 JenaValve Technology, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NPT, JenaValve Technology, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.