Identity
- Trade Name
- TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEAD FDA PMA
- Generic Name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER FDA PMA
Identifiers
- PMA Number
- P050023 FDA PMA
- FDA Product Code
- MRM FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
This device is an implantable dual-chamber defibrillator (CRT-D) designed for cardiac resynchronization therapy and defibrillation. The TUPOS LV/ATX and KRONOS LV-T CRT-D devices are intended for patients with symptomatic congestive heart failure (NYHA Class III/IV), reduced left ventricular ejection fraction (≤35%), and intraventricular conduction delay (QRS duration ≥130 ms). The TUPOS LV/ATX also addresses patients with atrial tachyarrhythmias or those at risk of developing them. The COROX OTW steroid lead is intended for coronary vein implantation to provide long-term cardiac pacing when paired with a compatible pulse generator.
These devices are supplied as implantable systems with associated programmer software (505.U for ICS 3000, A-K00.7.U for EPR/TMS 1000Plus) and are regulated under FDA_PMA (P050023). The COROX OTW steroid lead is single-use, intended for sterile implantation in cardiac settings. Device compatibility and programming are restricted to Biotronik’s ICS 3000, EPR/TMS 1000Plus, and COROX OTW systems. No MRI safety information is specified, and storage conditions are not detailed in the provided data.
Frequently asked questions
What specific patient conditions qualify for use of the TUPOS LV/ATX or KRONOS LV-T CRT-D devices, and how does the TUPOS LV/ATX differ in its indication?
The TUPOS LV/ATX and KRONOS LV-T are approved for patients with symptomatic congestive heart failure (NYHA Class III/IV), a left ventricular ejection fraction of 35% or less, and intraventricular conduction delay (QRS duration of 130 ms or greater). The TUPOS LV/ATX also includes patients with atrial tachyarrhythmias or those at risk of developing them, which is not a criterion for the KRONOS LV-T. Both are intended for cardiac resynchronization therapy and defibrillation.
Is the COROX OTW steroid lead reusable, and what is its intended use in a clinical setting?
The COROX OTW steroid lead is explicitly labeled as single-use and intended for sterile implantation in cardiac settings. It is designed for coronary vein implantation to provide long-term cardiac pacing when paired with a compatible pulse generator, such as the TUPOS LV/ATX or KRONOS LV-T CRT-D.
Which programmer software systems are compatible with these devices, and are they restricted to specific Biotronik platforms?
The TUPOS LV/ATX and KRONOS LV-T CRT-D systems require Biotronik’s proprietary programmer software: the **505.U** for the ICS 3000 platform and the **A-K00.7.U** for the EPR/TMS 1000Plus platform. The COROX OTW steroid lead is also restricted to use with these Biotronik systems, ensuring compatibility and proper functionality.
Are there any storage instructions provided for these devices, and what should clinicians consider regarding their handling?
The provided data does not specify storage conditions for the TUPOS LV/ATX, KRONOS LV-T, or COROX OTW steroid lead. Clinicians should follow Biotronik’s general guidelines for implantable cardiac devices, which typically include protection from extreme temperatures, moisture, and physical damage. Since the COROX OTW lead is single-use and sterile, it must be handled under aseptic conditions prior to implantation.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P050023 | Class III | Active |
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Manufacturer
- Manufacturer
- Biotronik, Inc.
Sources (1)
- FDA PMA P050023 24 fields · synced Oct 6, 2026