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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
DeviceCentriMag Circulatory Support System
Generic Nameventricular (assist) bypass
6035 stoneridge drive
pleasanton, CA 94588
PMA NumberP170038
Date Received11/24/2017
Decision Date12/06/2019
Product Code DSQ 
Docket Number 19M-5857
Notice Date 12/12/2019
Advisory Committee Cardiovascular
Clinical Trials NCT00819793
Expedited Review Granted? No
Combination Product No
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.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S005