FDA.reportPublic FDA data

PMA P160054S024

Device
HeartMate 3 Left Ventricular Assist System
Applicant
ABBOTT MEDICAL
PMA number
P160054
Supplement
S024
Product code
DSQ
Decision date
2019-12-30
Generic name
Ventricular (assist) bypass
Approval order statement
Approval for a revision of the Instructions for Use and Patient Handbook to provide further instructions on the management of electrostatic discharge.

Current openFDA PMA Record#

Device
HeartMate 3 Left Ventricular Assist System
Applicant
ABBOTT MEDICAL
PMA number
P160054
Supplement
S024
Product code
DSQ
Generic name
Ventricular (assist) bypass
Decision date
2019-12-30
Decision code
APPR
Date received
2019-12-03
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for a revision of the Instructions for Use and Patient Handbook to provide further instructions on the management of electrostatic discharge.