- Device
- HeartMate II Left Ventricular Assist System (LVAS)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P060040
- Supplement
- S076
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2020-06-26
- Decision code
- APPR
- Date received
- 2020-01-28
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for an alternate 3rd Tier yarn supplier to manufacture the vascular graft components for the HeartMate II and HeartMate 3 Left Ventricular Assist Systems (LVAS).