FDA.reportPublic FDA data

PMA P100047S189

Device
HeartWare HVAD System
Applicant
Medtronic
PMA number
P100047
Supplement
S189
Product code
DSQ
Decision date
2021-10-15
Generic name
Ventricular (assist) bypass
Approval order statement
Approval for dimensional changes to the internal core in the plug used in the battery, AC adapter, DC adapter, training plugs, monitor data cable, and red alarm adapter, and associated manufacturing changes.

Current openFDA PMA Record#

Device
HeartWare HVAD System
Applicant
Medtronic
PMA number
P100047
Supplement
S189
Product code
DSQ
Generic name
Ventricular (assist) bypass
Decision date
2021-10-15
Decision code
APPR
Date received
2021-07-19
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for dimensional changes to the internal core in the plug used in the battery, AC adapter, DC adapter, training plugs, monitor data cable, and red alarm adapter, and associated manufacturing changes.