PMA P160054S114
- Device
- HeartMate 3™ Left Ventricular Assist System (LVAS)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P160054
- Supplement
- S114
- Product code
- DSQ
- Decision date
- 2026-03-02
- Classification
- Cardiovascular
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- approval for an alternative supplier and minor design and manufacturing changes to the HeartMate 3 Potting Cup.
Current openFDA PMA Record#
- Device
- HeartMate 3™ Left Ventricular Assist System (LVAS)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P160054
- Supplement
- S114
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2026-03-02
- Decision code
- APPR
- Date received
- 2025-10-16
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for an alternative supplier and minor design and manufacturing changes to the HeartMate 3 Potting Cup.