PMA P170038S030

Device
CentriMag™ Circulatory Support System
Applicant
Abbott
PMA number
P170038
Supplement
S030
Product code
DSQ
Decision date
2026-05-04
Classification
Cardiovascular
Generic name
Ventricular (assist) bypass
Approval order statement
Approval for a modification to the electromagnetic compatibility (EMC) coating on the Mag Monitor housing

Current openFDA PMA Record#

Device
CentriMag™ Circulatory Support System
Applicant
Abbott
PMA number
P170038
Supplement
S030
Product code
DSQ
Generic name
Ventricular (assist) bypass
Decision date
2026-05-04
Decision code
APPR
Date received
2026-02-18
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for a modification to the electromagnetic compatibility (EMC) coating on the Mag Monitor housing