PMA P160054S118

Device: HeartMate 3™ Left Ventricular Assist System
Applicant: ABBOTT MEDICAL
PMA number: P160054
Supplement: S118
Product code: DSQ
Decision date: 2026-02-11
Classification: Cardiovascular
Generic name: Ventricular (assist) bypass
Approval order statement: a manufacturing site relocation for the supplier of the HeartMate 3 LVAS cable Bend Reliefs and the qualification of associated injection molding equipment

Current openFDA PMA Record#

Device: HeartMate 3™ Left Ventricular Assist System
Applicant: ABBOTT MEDICAL
PMA number: P160054
Supplement: S118
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 2026-02-11
Decision code: OK30
Date received: 2026-01-15
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: a manufacturing site relocation for the supplier of the HeartMate 3 LVAS cable Bend Reliefs and the qualification of associated injection molding equipment