FDA applicant

JenaValve Technology, Inc.

Irvine1 decision2026–20263 recalls

FDA records 1 decision for JenaValve Technology, Inc. (Irvine) in 2026: 1 original PMA approval. All are in product code NPT (Aortic Valve, Prosthesis, Percutaneously…). 3 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided JenaValve Technology, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2026

2026high 1 (2026)2026

2026 so far, outlined.

Recalls per year

3in 2026

2026high 3 (2026)2026

Class I Class II/III not classified

FIG. 1 — JenaValve Technology, Inc. by year, 2026–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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JenaValve Technology, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

What has been recalled?