PMA P160054S112
- Device
- HeartMate 3™ Left Ventricular Assist System (LVAS)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P160054
- Supplement
- S112
- Product code
- DSQ
- Decision date
- 2025-11-04
- Classification
- Cardiovascular
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Approval for a material additive change to the resin used in the internal layer of the HeartMate 3 Modular Cable and Percutaneous Cable.
Current openFDA PMA Record#
- Device
- HeartMate 3™ Left Ventricular Assist System (LVAS)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P160054
- Supplement
- S112
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2025-11-04
- Decision code
- APPR
- Date received
- 2025-09-02
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a material additive change to the resin used in the internal layer of the HeartMate 3 Modular Cable and Percutaneous Cable.