FDA.reportPublic FDA data

PMA P060040S050

Device
THORATEC HEARTMATE LEFT VENTRICULAR ASSIST SYSTEM DEVICE (LVAS)
Applicant
ABBOTT MEDICAL
PMA number
P060040
Supplement
S050
Product code
DSQ
Decision date
2016-02-18
Classification
Ventricular (assist) Bypass
Generic name
Ventricular (assist) bypass
Approval order statement
Approval for revisions to the labeling for the HeartMate® II Left Ventricular Assist System with Pocket Controller and HeartMate® II Left Ventricular Assist System with Pocket Controller and Mobile Power Unit (MPU).

Current openFDA PMA Record#

Device
THORATEC HEARTMATE LEFT VENTRICULAR ASSIST SYSTEM DEVICE (LVAS)
Applicant
ABBOTT MEDICAL
PMA number
P060040
Supplement
S050
Product code
DSQ
Generic name
Ventricular (assist) bypass
Decision date
2016-02-18
Decision code
APPR
Date received
2016-01-21
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for revisions to the labeling for the HeartMate® II Left Ventricular Assist System with Pocket Controller and HeartMate® II Left Ventricular Assist System with Pocket Controller and Mobile Power Unit (MPU).