CentriMag Circulatory Support System

FDA premarket approval P170038 · Ventricular (assist) bypass

PMA numberP170038

Approval

Applicant
Abbott
Received
November 24, 2017
Decision date
December 6, 2019 (APPR)
Supplements
31, latest September 2, 2026
Product code
DSQ – Ventricular (Assist) Bypass

Official FDA PMA record

Approval order statement

Approval for temporary circulatory support for up to 30 days for one or both sides of the heart to treat postcardiotomy patients who fail to wean from cardiopulmonary bypass, providing a bridge to decision when it is unclear whether the patient's heart will recover or whether the patient will need alternative, longer-term therapy.