PMA P160054
- Device
- HeartMate 3™ Left Ventricular Assist System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P160054
- Supplement
- S050
- Product code
- DSQ
- Decision date
- 2026-09-09
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- adding an alternative supplier for the pump rotor subassembly
Current openFDA PMA Record#
- Device
- HeartMate 3™ Left Ventricular Assist System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P160054
- Supplement
- S134
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2026-09-09
- Decision code
- OK30
- Date received
- 2026-08-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- adding an alternative supplier for the pump rotor subassembly