PMA P160054S094

Device: HeartMate 3 Left Ventricular Assist System, HeartMate II Left Ventricular Assist System
Applicant: ABBOTT MEDICAL
PMA number: P160054
Supplement: S094
Product code: DSQ
Decision date: 2025-10-17
Classification: Cardiovascular
Generic name: Ventricular (assist) bypass
Approval order statement: Approval for adding another supplier of the Coring Knife sub-assembly and implementing a new cutting test fixture at the supplier and at Abbott receiving inspection.

Current openFDA PMA Record#

Device: HeartMate 3 Left Ventricular Assist System, HeartMate II Left Ventricular Assist System
Applicant: ABBOTT MEDICAL
PMA number: P160054
Supplement: S094
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 2025-10-17
Decision code: APPR
Date received: 2025-01-15
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for adding another supplier of the Coring Knife sub-assembly and implementing a new cutting test fixture at the supplier and at Abbott receiving inspection.