POI

Lung Tissue Sealant For Lung Volume Reduction

Product code
POI
Device name
Lung Tissue Sealant For Lung Volume Reduction
Device class
Class N
Medical specialty
Unknown
Marketing pathway
Contact ODE
Flag
Implant

FDA classification definition

The system is intended to reduce lung volume irreversibly by employing a synthetic polymer to seal airways in order to improve lung function and quality of life in patients with advanced emphysema. It functions by physically occluding both small airways and collateral air channels through sealing lung tissue, causing the treated area to collapse via absorption atelectasis. It is a single use device intended to be used by pulmonologists and thoracic surgeons in a bronchoscopy suite or operating room.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: POI
Classification and pathway per current FDA publications. Data from openFDA (CC0).