CentriMag Circulatory Support System
FDA PMAClass III (US FDA PMA)
by Abbott
Identity
- Trade Name
- CentriMag Circulatory Support System FDA PMA
- Generic Name
- Ventricular (assist) bypass FDA PMA
Identifiers
- PMA Number
- P170038 FDA PMA
- FDA Product Code
- DSQ FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The CentriMag Circulatory Support System is a ventricular (assist) bypass device designed for temporary circulatory support. It is indicated for use in postcardiotomy patients who fail to wean from cardiopulmonary bypass, providing support for up to 30 days for one or both sides of the heart.
The system is supplied as a reusable system with disposable components, intended for use in hospital settings under clinical supervision. It received FDA PMA approval (P170038) on December 6, 2019, and is classified as a Class III device under product code DSQ.
Frequently asked questions
What is the maximum duration of support provided by the CentriMag Circulatory Support System?
The CentriMag Circulatory Support System provides temporary circulatory support for up to 30 days, as stated in its approval documentation for treating postcardiotomy patients who fail to wean from cardiopulmonary bypass.
Is the CentriMag Circulatory Support System approved for use in both left and right heart support?
Yes, the system is approved to provide temporary circulatory support for one or both sides of the heart, meaning it can support the left ventricle, right ventricle, or both simultaneously, depending on patient needs.
What regulatory pathway was used for the CentriMag Circulatory Support System's approval?
The CentriMag Circulatory Support System received approval through the FDA Premarket Approval (PMA) pathway, with PMA number P170038, and was granted approval on December 6, 2019.
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 | P170038 | Class III | Active |
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Manufacturer
- Manufacturer
- Abbott
Sources (1)
- FDA PMA P170038 24 fields · synced Sep 18, 2026