PMA P160054S031
- Device
- HeartMate 3 Left Ventricular Assist System (HM3 LVAS)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P160054
- Supplement
- S031
- Product code
- DSQ
- Decision date
- 2020-12-17
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Approval for a labeling update regarding pediatric uses of the device.
Current openFDA PMA Record#
- Device
- HeartMate 3 Left Ventricular Assist System (HM3 LVAS)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P160054
- Supplement
- S031
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2020-12-17
- Decision code
- APPR
- Date received
- 2020-07-01
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for a labeling update regarding pediatric uses of the device.