FDA.reportPublic FDA data

PMA P100047S171

Device
HeartWare Ventricular Assist System
Applicant
Medtronic
PMA number
P100047
Supplement
S171
Product code
DSQ
Decision date
2020-09-30
Generic name
Ventricular (assist) bypass
Approval order statement
Implement updated test software for the HeartWare Ventricular Assist Device (HVAD), Battery Pack, Printed Circuit Board Assembly (PCBA) test to automatically verify the firmware and configuration file.

Current openFDA PMA Record#

Device
HeartWare Ventricular Assist System
Applicant
Medtronic
PMA number
P100047
Supplement
S171
Product code
DSQ
Generic name
Ventricular (assist) bypass
Decision date
2020-09-30
Decision code
OK30
Date received
2020-08-31
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Implement updated test software for the HeartWare Ventricular Assist Device (HVAD), Battery Pack, Printed Circuit Board Assembly (PCBA) test to automatically verify the firmware and configuration file.