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Lung Tissue Sealant For Lung Volume Reduction

POI · Not classified · Unknown

Classification

FDA Product Code
POI
Device class
Not classified
Regulation
Review panel
AN
Medical specialty
Unknown
Submission type
3
GMP exempt
N
Life sustaining
N
Implant
Y
Third-party review
N

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.

Market data

Cleared 510(k) submissions
0
Registered establishments
2

Source

Authoritative
FDA Device Classification database
Machine
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