PMA P170038S032

Device
CentriMag™ Circulatory Support System
Applicant
Abbott
PMA number
P170038
Supplement
S032
Product code
DSQ
Decision date
2026-09-02
Classification
Cardiovascular
Generic name
Ventricular (assist) bypass
Approval order statement
replacement of the existing wave soldering equipment with new wave soldering equipment

Current openFDA PMA Record#

Device
CentriMag™ Circulatory Support System
Applicant
Abbott
PMA number
P170038
Supplement
S032
Product code
DSQ
Generic name
Ventricular (assist) bypass
Decision date
2026-09-02
Decision code
OK30
Date received
2026-08-04
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
replacement of the existing wave soldering equipment with new wave soldering equipment