PMA P060040

Device: HeartMate II Left Ventricular Assist System
Applicant: ABBOTT MEDICAL
PMA number: P060040
Supplement: S089
Product code: DSQ
Decision date: 2026-07-09
Generic name: Ventricular (assist) bypass
Approval order statement: use of a new grinding equipment and process for the manufacturing of the blade of the Apical Coring Knife, a shared component of the HeartMate II Left Ventricular Assist System (HMII LVAS) and the HeartMate 3 Left Ventricular Assist System (HM3 LVAS)

Current openFDA PMA Record#

Device: HeartMate II Left Ventricular Assist System
Applicant: ABBOTT MEDICAL
PMA number: P060040
Supplement: S125
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 2026-07-09
Decision code: OK30
Date received: 2026-06-12
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: use of a new grinding equipment and process for the manufacturing of the blade of the Apical Coring Knife, a shared component of the HeartMate II Left Ventricular Assist System (HMII LVAS) and the HeartMate 3 Left Ventricular Assist System (HM3 LVAS)