PMA P170038S027

Device
CentriMag Circulatory Support System
Applicant
Abbott
PMA number
P170038
Supplement
S027
Product code
DSQ
Decision date
2026-02-03
Classification
Cardiovascular
Generic name
Ventricular (assist) bypass
Approval order statement
Change in the supplier for the flat ribbon cable component

Current openFDA PMA Record#

Device
CentriMag Circulatory Support System
Applicant
Abbott
PMA number
P170038
Supplement
S027
Product code
DSQ
Generic name
Ventricular (assist) bypass
Decision date
2026-02-03
Decision code
OK30
Date received
2026-01-05
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Change in the supplier for the flat ribbon cable component