← Product Code LWS · P980023

# PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM (P980023)

_Biotronik, Inc. · LWS · Oct 27, 1998 · Cardiovascular · APPR_

**Canonical URL:** https://fda.innolitics.com/device/P980023

## Device Facts

- **Applicant:** Biotronik, Inc.
- **Product Code:** LWS
- **Decision Date:** Oct 27, 1998
- **Decision:** APPR
- **Device Class:** Class 3
- **Review Panel:** Cardiovascular

## Regulatory Identification

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

---

**Source:** [https://fda.innolitics.com/device/P980023](https://fda.innolitics.com/device/P980023)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a PMA](https://innolitics.com/services/regulatory/), [a 510(k)](https://innolitics.com/services/510ks/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com