PMA P160054S018
- Device
- HeartMate 3 (HM3) Left Ventricular Assist System (LVAS)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P160054
- Supplement
- S018
- Product code
- DSQ
- Decision date
- 2019-05-01
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Approval for various design modifications to the Pump Cover component.
Current openFDA PMA Record#
- Device
- HeartMate 3 (HM3) Left Ventricular Assist System (LVAS)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P160054
- Supplement
- S018
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2019-05-01
- Decision code
- APPR
- Date received
- 2019-02-19
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for various design modifications to the Pump Cover component.