PMA P160054S036
- Device
- HeartMate 3™ Left Ventricular Assist System (LVAS)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P160054
- Supplement
- S036
- Product code
- DSQ
- Decision date
- 2021-04-28
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Addition of a new test fixture for the HeartMate 3 Left Ventricular Device.
Current openFDA PMA Record#
- Device
- HeartMate 3™ Left Ventricular Assist System (LVAS)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P160054
- Supplement
- S036
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2021-04-28
- Decision code
- OK30
- Date received
- 2021-03-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a new test fixture for the HeartMate 3 Left Ventricular Device.