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 Airw
| Device Type ID | 234 |
| Device Name | Lung Tissue Sealant For Lung Volume Reduction |
| Physical State | The Foam Is Prepared Immediately Prior To Administration Using A Standard Accessory (stopcock) And Mixing Together The Following: • Solution A (4.5 ML Of Solution Containing 2.1% (w/v) Of Aminated Polyvinyl Alcohol [aPVA]) • Solution B (0.5 ML Of Sol |
| Technical Method | The AeriSeal System Is Designed To Produce Lung Volume Reduction By Physically Occluding Airways, Leading To Reduced Gas Trapping In Order To Improve Lung Function And Quality Of Life In Patients With Advanced Emphysema. A Single Subsegmental Treatme |
| Target Area | Small Airways And Collateral Air Channels Of The Lung |
| Review Panel | Anesthesiology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Respiratory Devices Branch (RPDB) |
| Submission Type | Contact ODE |
| FDA Device Classification | Class Not Classified Medical Device |
| Product Code | POI |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 234 |
| Device | Lung Tissue Sealant For Lung Volume Reduction |
| Product Code | POI |