Definition: To Restrict Air Flow To The Target Section Of The Lung. To Control Prolonged Air Leaks Of The Lung, Or Significant Air Leaks That Are Likely To Become Prolonged Air Leaks, Following Lobectomy, Segmentectomy, Or Lung Volume Reduction Surgery (lvrs). A
| Device Type ID | 5954 |
| Device Name | One-way Air-leak Valve |
| Physical State | This Device Is A Small Nitinol Frame That Has A Polyurethane Membrane Over The Nitinol Frame That Acts As A Plug To The Targeted Section Of The Lung. |
| Technical Method | The Device Is A Nitonal Frame With A Polyurethane Membrane Over The Nitinol Frame. The Valve Does Not Allow Air Into The Targeted Segment Of The Lung, But Does Allow Air And Mucus Out Of That Lung Section. |
| Target Area | The Device Is Intended To Occlude A Section Of Lung. |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) Plastic And Reconstructive Surgery Devices Branch Two - Skin/Wound Dressing/Aesthetic Injectables (PRSB2) |
| Submission Type | HDE - Humanitarian Device Exem |
| FDA Device Classification | Class HDE Medical Device |
| Product Code | OAZ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5954 |
| Device | One-way Air-leak Valve |
| Product Code | OAZ |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 11 |
No Apparent Adverse Event | 1 |
| Total Device Problems | 12 |