PMA P160054S009

Device: HeartMate 3 Left Ventricular Assist System (LVAS)
Applicant: ABBOTT MEDICAL
PMA number: P160054
Supplement: S009
Product code: DSQ
Decision date: 2018-06-01
Classification: Ventricular (assist) Bypass
Generic name: Ventricular (assist) bypass
Approval order statement: Add an alternative second tier supplier of a component used to manufacture the Sealed Outflow Graft and to add a new cleanroom for manufacturing the graft.

Current openFDA PMA Record#

Device: HeartMate 3 Left Ventricular Assist System (LVAS)
Applicant: ABBOTT MEDICAL
PMA number: P160054
Supplement: S009
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 2018-06-01
Decision code: OK30
Date received: 2018-05-04
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Add an alternative second tier supplier of a component used to manufacture the Sealed Outflow Graft and to add a new cleanroom for manufacturing the graft.