Premarket Approval (PMA)

Note: 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.

• Device: CentriMag Circulatory Support System
• Generic Name: Ventricular (assist) bypass
• Applicant: Abbott; 6035 Stoneridge Dr.; Pleasanton, CA 94588
• PMA Number: P170038
• Supplement Number: S005
• Date Received: 07/31/2020
• Decision Date: 08/28/2020
• Product Code: DSQ
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval of the revised protocol for the post-approval study (PAS) protocol.