Spiration® Valve System

FDA premarket approval P180007 · Valve, pulmonary

PMA numberP180007

Approval

Applicant
Gyrus Acmi, Inc.
Received
February 5, 2018
Decision date
December 3, 2018 (APPR)
Supplements
11, latest August 20, 2026
Product code
NJK – Valve, Pulmonary

Official FDA PMA record

Approval order statement

Approval of the Spiration® Valve System. The Spiration® Valves are one-way endobronchial valves indicated for adult patients with shortness of breath and hyperinflation associated with severe emphysema in regions of the lung that have low collateral ventilation.