PMA P160054S045
- Device
- HeartMate 3™ Left Ventricular Assist System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P160054
- Supplement
- S045
- Product code
- DSQ
- Decision date
- 2022-01-28
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Approval for the HeartMate Touch App software upgrade from version 1.0.17 to version 1.0.32.
Current openFDA PMA Record#
- Device
- HeartMate 3™ Left Ventricular Assist System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P160054
- Supplement
- S045
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2022-01-28
- Decision code
- APPR
- Date received
- 2021-12-16
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the HeartMate Touch App software upgrade from version 1.0.17 to version 1.0.32.