PMA P160054S013
- Device
- HeartMate 3™ Left Ventricular Assist System (LVAS)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P160054
- Supplement
- S013
- Product code
- DSQ
- Decision date
- 2018-10-05
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Approval for the HeartMate 3 Outflow Graft Clip component.
Current openFDA PMA Record#
- Device
- HeartMate 3™ Left Ventricular Assist System (LVAS)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P160054
- Supplement
- S013
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2018-10-05
- Decision code
- APPR
- Date received
- 2018-09-04
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the HeartMate 3 Outflow Graft Clip component.