# MRM · Defibrillator, Implantable, Dual-Chamber

_ ·  · Class 3_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/CV-misc/MRM

## Overview

- **Product Code:** MRM
- **Device Name:** Defibrillator, Implantable, Dual-Chamber
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)
- **Implant:** yes
- **Life-sustaining:** yes

## Recent Cleared Devices (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P050023](https://fda.innolitics.com/submissions/CV/CV-misc/MRM/P050023.md) | TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEAD | Biotronik, Inc. | Aug 10, 2006 | APPR |
| [P000009](https://fda.innolitics.com/submissions/CV/CV-misc/MRM/P000009.md) | PHYLAX AV ICD SYSTEM | Biotronik, Inc. | Sep 29, 2000 | APPR |
| [P980049](https://fda.innolitics.com/submissions/CV/CV-misc/MRM/P980049.md) | DEFENDER II MODEL 9201 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | MicroPort CRM USA, Inc. | Sep 15, 1999 | APPR |

## Top Applicants

- Biotronik, Inc. — 2 clearances
- MicroPort CRM USA, Inc. — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/CV/CV-misc/MRM](https://fda.innolitics.com/submissions/CV/CV-misc/MRM)

**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 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [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