PMA P100047S108

Device: HeartWare Ventricular Assist System
Applicant: Medtronic
PMA number: P100047
Supplement: S108
Product code: DSQ
Decision date: 2017-09-11
Classification: Ventricular (assist) Bypass
Generic name: Ventricular (assist) bypass
Approval order statement: Implementation of process changes at a Tier 2 supplier and a new visual inspection at the contract manufacturer for the AC and DC adapter components used within the HeartWare Ventricular Assist Device.

Current openFDA PMA Record#

Device: HeartWare Ventricular Assist System
Applicant: Medtronic
PMA number: P100047
Supplement: S108
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 2017-09-11
Decision code: OK30
Date received: 2017-08-16
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Implementation of process changes at a Tier 2 supplier and a new visual inspection at the contract manufacturer for the AC and DC adapter components used within the HeartWare Ventricular Assist Device.