POI — Lung Tissue Sealant For Lung Volume Reduction Class N
FDA product code POI covers "Lung Tissue Sealant For Lung Volume Reduction", a Class N medical device. Submissions are reviewed by the Unknown panel. Devices under this code are implants.
Classification Details
- Product Code
- POI
- Device Class
- Class N
- Regulation Number
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Unknown
- Implant
- Yes
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.