Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart D — Cardiovascular Prosthetic Devices](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices) → [21 CFR 870.3650](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/870.3650) → DSW — Bag, Polymeric Mesh, Pacemaker

# DSW · Bag, Polymeric Mesh, Pacemaker

_Cardiovascular · 21 CFR 870.3650 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DSW

## Overview

- **Product Code:** DSW
- **Device Name:** Bag, Polymeric Mesh, Pacemaker
- **Regulation:** [21 CFR 870.3650](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/870.3650)
- **Device Class:** 1
- **Review Panel:** [Cardiovascular](/submissions/CV)
- **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._

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DSW](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DSW)

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