PMA P160054S116
- Device
- HeartMate 3™ Left Ventricular Assist System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P160054
- Supplement
- S116
- Product code
- DSQ
- Decision date
- 2025-12-17
- Classification
- Cardiovascular
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Alternate MOSFET and capacitor components in the Power Supply Printed Circuit Board Assembly (PCBA) of the Universal Battery Charger (UBC)
Current openFDA PMA Record#
- Device
- HeartMate 3™ Left Ventricular Assist System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P160054
- Supplement
- S116
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2025-12-17
- Decision code
- OK30
- Date received
- 2025-11-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternate MOSFET and capacitor components in the Power Supply Printed Circuit Board Assembly (PCBA) of the Universal Battery Charger (UBC)