PMA P170038S029

Device: CentriMag™ Circulatory Support System
Applicant: Abbott
PMA number: P170038
Supplement: S029
Product code: DSQ
Decision date: 2026-04-17
Classification: Cardiovascular
Generic name: Ventricular (assist) bypass
Approval order statement: Approval for labeling changes to the CentriMag Motor Instructions for Use (IFU), CentriMag Blood Pump IFU, and CentriMag Circulatory Support System Operation Manual.

Current openFDA PMA Record#

Device: CentriMag™ Circulatory Support System
Applicant: Abbott
PMA number: P170038
Supplement: S029
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 2026-04-17
Decision code: APPR
Date received: 2026-02-02
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for labeling changes to the CentriMag Motor Instructions for Use (IFU), CentriMag Blood Pump IFU, and CentriMag Circulatory Support System Operation Manual.