Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA PMA

Stent, vena cava

PMA Number: P250017 · 2026-04-30

ApplicantW. L. Gore & Associates, Inc.
Decision Date2026-04-30
PMA NumberP250017
Product CodeQTL
Advisory CommitteeCV

Device Summary

Stent, vena cava is a medical device manufactured by W. L. Gore & Associates, Inc.. It received FDA Premarket Approval (PMA) on 2026-04-30 under PMA number P250017. The device is classified under FDA product code QTL. It was reviewed by the CV advisory panel. Unlike 510(k) clearance, which demonstrates substantial equivalence to a predicate device, PMA requires the manufacturer to submit clinical trial data demonstrating the safety and effectiveness of the device. PMA is generally required for Class III devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury.

Frequently Asked Questions

What is Stent, vena cava?

Stent, vena cava is a medical device that received FDA Premarket Approval (PMA) on 2026-04-30. It is manufactured by W. L. Gore & Associates, Inc.. The PMA number is P250017.

When did Stent, vena cava receive FDA PMA approval?

Stent, vena cava received FDA PMA approval on 2026-04-30, under approval number P250017.

What company makes Stent, vena cava?

Stent, vena cava is manufactured by W. L. Gore & Associates, Inc..

What is the difference between PMA and 510(k)?

PMA (Premarket Approval) is the FDA process for evaluating Class III medical devices. Unlike 510(k) clearance, which demonstrates substantial equivalence to a predicate device, PMA requires the manufacturer to provide clinical data proving safety and effectiveness. PMA is the most stringent type of device marketing application required by the FDA.

What is the FDA product code for Stent, vena cava?

The FDA product code for Stent, vena cava is QTL.

Other Devices by W. L. Gore & Associates, Inc.

PMA P020004SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT PMA P050006Transcatheter septal occluder PMA P020004SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

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.

↑