Definition: To Improve Lung Function In Patients With Emphysema
| Device Type ID | 229 |
| Device Name | Valve, Pulmonary |
| Review Panel | Anesthesiology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch One - Light Based/Laser (GSDB1) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | NJK |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 229 |
| Device | Valve, Pulmonary |
| Product Code | NJK |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 24 |
Material Split, Cut Or Torn | 5 |
Device Contamination With Chemical Or Other Material | 1 |
| Total Device Problems | 30 |