← Product Code [LWS](/productcode/LWS) · P980050S001

# JEWEL AF SYSTEM (P980050S001)

_Medtronic, Inc. · LWS · Apr 6, 2001 · Cardiovascular · APPR_

**Canonical URL:** https://fda.innolitics.com/device/P980050S001

## Device Facts

- **Applicant:** Medtronic, Inc.
- **Product Code:** [LWS](/productcode/LWS.md)
- **Decision Date:** Apr 6, 2001
- **Decision:** APPR
- **Device Class:** Class 3
- **Review Panel:** Cardiovascular

## Regulatory Identification

These devices treat tachycardia (fast heartbeats) with RV defibrillation therapy as necessary.

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**Source:** [https://fda.innolitics.com/device/P980050S001](https://fda.innolitics.com/device/P980050S001)

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