PMA P160054S019

Device: HeartMate 3™ Left Ventricular Assist System (LVAS)
Applicant: ABBOTT MEDICAL
PMA number: P160054
Supplement: S019
Product code: DSQ
Decision date: 2019-08-12
Classification: Ventricular (assist) Bypass
Generic name: Ventricular (assist) bypass
Approval order statement: Approval for a manufacturing site located at Sterigenics in Salt Lake City, Utah for ethylene oxide sterilization of the HeartMate 3 LVAS and HeartMate II LVAS components.

Current openFDA PMA Record#

Device: HeartMate 3™ Left Ventricular Assist System (LVAS)
Applicant: ABBOTT MEDICAL
PMA number: P160054
Supplement: S019
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 2019-08-12
Decision code: APPR
Date received: 2019-06-19
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a manufacturing site located at Sterigenics in Salt Lake City, Utah for ethylene oxide sterilization of the HeartMate 3 LVAS and HeartMate II LVAS components.