FDA.reportPublic FDA data

PMA P160054S007

Device
HeartMate 3™ Left Ventricular Assist System (LVAS)
Applicant
ABBOTT MEDICAL
PMA number
P160054
Supplement
S007
Product code
DSQ
Decision date
2018-07-05
Classification
Ventricular (assist) Bypass
Generic name
Ventricular (assist) bypass
Approval order statement
Approval for introducing: 1) various design modifications to the Tunneling Adapter and Tunneling Lance; 2) various design modifications to the HeartMate 3 LVAD inner tray; and 3) a standalone packaging configuration for the modified Tunneling Adapter, with a shelf life of 3 years.

Current openFDA PMA Record#

Device
HeartMate 3™ Left Ventricular Assist System (LVAS)
Applicant
ABBOTT MEDICAL
PMA number
P160054
Supplement
S007
Product code
DSQ
Generic name
Ventricular (assist) bypass
Decision date
2018-07-05
Decision code
APPR
Date received
2018-04-16
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for introducing: 1) various design modifications to the Tunneling Adapter and Tunneling Lance; 2) various design modifications to the HeartMate 3 LVAD inner tray; and 3) a standalone packaging configuration for the modified Tunneling Adapter, with a shelf life of 3 years.