| Device Type ID | 776 |
| Device Name | Bag, Polymeric Mesh, Pacemaker |
| Regulation Description | Pacemaker Polymeric Mesh Bag. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Vascular Surgery Devices Branch (VSDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 870.3650 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | DSW |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 776 |
| Device | Bag, Polymeric Mesh, Pacemaker |
| Product Code | DSW |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Pacemaker Polymeric Mesh Bag. |
| CFR Regulation Number | 870.3650 [🔎] |
| Device Problems | |
|---|---|
Mechanical Problem | 7 |
| Total Device Problems | 7 |