FDA.reportPublic FDA data

PMA P160054S034

Device
HeartMate 3 Left Ventricular Assist System
Applicant
ABBOTT MEDICAL
PMA number
P160054
Supplement
S034
Product code
DSQ
Decision date
2021-03-21
Generic name
Ventricular (assist) bypass
Approval order statement
Addition of 5 alternate components from alternate second tier suppliers for the HeartMate 3 System Controller PCBAs, one of which is a shared component with the HeartMate II System Controller PCBA.

Current openFDA PMA Record#

Device
HeartMate 3 Left Ventricular Assist System
Applicant
ABBOTT MEDICAL
PMA number
P160054
Supplement
S034
Product code
DSQ
Generic name
Ventricular (assist) bypass
Decision date
2021-03-21
Decision code
OK30
Date received
2021-02-19
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Addition of 5 alternate components from alternate second tier suppliers for the HeartMate 3 System Controller PCBAs, one of which is a shared component with the HeartMate II System Controller PCBA.