DSW · Bag, Polymeric Mesh, Pacemaker
Cardiovascular · 21 CFR 870.3650 · Class 1
Overview
| Product Code | DSW |
|---|---|
| Device Name | Bag, Polymeric Mesh, Pacemaker |
| Regulation | 21 CFR 870.3650 |
| Device Class | Class 1 |
| Review Panel | Cardiovascular |
| Implant | Yes |
Identification
A pacemaker polymeric mesh bag is an implanted device used to hold a pacemaker pulse generator. The bag is designed to create a stable implant environment for the pulse generator.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
