PMA P160054S001

Device: Thoratec HeartMate II and HeartMate 3 Ventricular Assist System (LVAS)
Applicant: ABBOTT MEDICAL
PMA number: P160054
Supplement: S001
Product code: DSQ
Decision date: 2017-10-12
Classification: Ventricular (assist) Bypass
Generic name: Ventricular (assist) bypass
Approval order statement: Implement a supplier facility relocation for a Printed Circuit Board Assembly (PCBA) of the HeartMate II LVAS and HeartMate 3 LVAS.

Current openFDA PMA Record#

Device: Thoratec HeartMate II and HeartMate 3 Ventricular Assist System (LVAS)
Applicant: ABBOTT MEDICAL
PMA number: P160054
Supplement: S001
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 2017-10-12
Decision code: OK30
Date received: 2017-09-08
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Implement a supplier facility relocation for a Printed Circuit Board Assembly (PCBA) of the HeartMate II LVAS and HeartMate 3 LVAS.