FDA.reportPublic FDA data

PMA P100047S169

Device
HeartWare HVAD System
Applicant
Medtronic
Product code
DSQ
Decision date
2020-12-21
Generic name
Ventricular (assist) bypass
Approval order statement
Approval for a change in material (from nylon to PEEK) of 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 labeling and manufacturing changes.

Current openFDA PMA Record#

Device
HeartWare HVAD System
Applicant
Medtronic
PMA number
P100047
Supplement
S169
Product code
DSQ
Generic name
Ventricular (assist) bypass
Decision date
2020-12-21
Decision code
APPR
Date received
2020-07-01
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for a change in material (from nylon to PEEK) of 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 labeling and manufacturing changes.