FDA PMA

Aortic stent

PMA Number: P240003 · 2026-08-27

ApplicantRenata Medical, Inc.

Decision Date2026-08-27

PMA NumberP240003

Product CodePNF

Device ClassClass 3

Medical SpecialtyU

Advisory CommitteeCV

Device Summary

Aortic stent is the device name listed in this FDA 510(k) record. The listed applicant is Renata Medical, Inc.. It received FDA 510(k) clearance on 2026-08-27. The device is classified under product code PNF. It was reviewed by the CV advisory panel.

Frequently Asked Questions

What is the Aortic stent?

Aortic stent is a medical device that received FDA 510(k) clearance on 2026-08-27. The listed applicant is Renata Medical, Inc..

When did Aortic stent receive FDA 510(k) clearance?

The clearance date for Aortic stent can be found in the official FDA records.

Who is the listed applicant for Aortic stent?

The FDA 510(k) record lists Renata Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aortic stent?

The FDA product code for Aortic stent is PNF.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT04745156A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade GliomasNOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.