510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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POINot classified

Lung Tissue Sealant For Lung Volume Reduction

Unknown
FDA source (opens on fda.gov)

POI is the FDA product code for Lung Tissue Sealant For Lung Volume Reduction. FDA's definition for this code reads: "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...". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
POI
Device name
Lung Tissue Sealant For Lung Volume Reduction
FDA 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.
Device class
Not classified
Review panel
Unknown
Submission type
Contact ODE
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code