- Device
- HeartMate 3™ Left Ventricular Assist System (LVAS)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P160054
- Supplement
- S044
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2022-01-12
- Decision code
- APPR
- Date received
- 2021-12-14
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for addendums to Instructions for Use and Patient Handbook for HeartMate 3 Left Ventricular Assist System (LVAS) and HeartMate II Left Ventricular Assist System (LVAS)