FDA.reportPublic FDA data

PMA P060040S089

Device
HeartMate II Left Ventricular Assist System (LVAS)
Applicant
ABBOTT MEDICAL
PMA number
P060040
Supplement
S089
Product code
DSQ
Decision date
2023-01-10
Generic name
Ventricular (assist) bypass
Approval order statement
Approval for a software update to the HeartMate Touch Communication (HM Touch) Application software to fix two anomalies and add eleven new language translations.

Current openFDA PMA Record#

Device
HeartMate II Left Ventricular Assist System (LVAS)
Applicant
ABBOTT MEDICAL
PMA number
P060040
Supplement
S089
Product code
DSQ
Generic name
Ventricular (assist) bypass
Decision date
2023-01-10
Decision code
APPR
Date received
2022-10-31
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for a software update to the HeartMate Touch Communication (HM Touch) Application software to fix two anomalies and add eleven new language translations.