PMA P160054S032
- Device
- HeartMate 3 Left Ventricular Assist System (HM3 LVAS)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P160054
- Supplement
- S032
- Product code
- DSQ
- Decision date
- 2020-10-20
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Approval for the Controller Main Application software upgrade from version 1.6 to version 1.7.
Current openFDA PMA Record#
- Device
- HeartMate 3 Left Ventricular Assist System (HM3 LVAS)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P160054
- Supplement
- S032
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2020-10-20
- Decision code
- APPR
- Date received
- 2020-07-22
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the Controller Main Application software upgrade from version 1.6 to version 1.7.