CentriMag Circulatory Support System

FDA Premarket Approval P170038 S005

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval of the revised protocol for the post-approval study (pas) referenced above. The pas protocol has been submitted to comply with the conditions of approval outlined in our approval order for p170038

DeviceCentriMag Circulatory Support System
Generic NameVentricular (assist) Bypass
Date Received2020-07-31
Decision Date2020-08-28
Product CodeDSQ 
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol - Ode/oir
Expedited ReviewNo
Combination Product No
Applicant Address Abbott 6035 Stoneridge Drive pleasanton, CA 94588

Supplemental Filings

Supplement NumberDateSupplement Type
P170038Original Filing
S005 2020-07-31 Normal 180 Day Track No User Fee
S003 2020-04-01 30-day Notice
S001 2020-01-08 Normal 180 Day Track No User Fee

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