PMA P160054S029
- Device
- HeartMate 3 Left Ventricular Assist System (LVAS)
- Applicant
- ABBOTT MEDICAL
- Product code
- DSQ
- Decision date
- 2020-07-10
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Approval for a packaging design change and a supplier process change to the HeartMate 3 Coring Tool.
Current openFDA PMA Record#
- Device
- HeartMate 3 Left Ventricular Assist System (LVAS)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P160054
- Supplement
- S029
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2020-07-10
- Decision code
- APPR
- Date received
- 2020-04-16
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a packaging design change and a supplier process change to the HeartMate 3 Coring Tool.