PMA P100047S103

Device: HeartWare Left Ventricular Assist Device System
Applicant: Medtronic
PMA number: P100047
Supplement: S103
Product code: DSQ
Decision date: 2017-08-17
Classification: Ventricular (assist) Bypass
Generic name: Ventricular (assist) bypass
Approval order statement: Addition of tolerances to a specification and a revised inspection method for seal strength at the supplier of the HeartWare Ventricular Assist Device Outflow Graft.

Current openFDA PMA Record#

Device: HeartWare Left Ventricular Assist Device System
Applicant: Medtronic
PMA number: P100047
Supplement: S103
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 2017-08-17
Decision code: OK30
Date received: 2017-07-20
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Addition of tolerances to a specification and a revised inspection method for seal strength at the supplier of the HeartWare Ventricular Assist Device Outflow Graft.