PMA P100047S098

Device: HeartWare Ventricular Assist System
Applicant: Medtronic
PMA number: P100047
Supplement: S098
Product code: DSQ
Decision date: 2017-06-27
Classification: Ventricular (assist) Bypass
Generic name: Ventricular (assist) bypass
Approval order statement: Modification to the manufacturing and quality inspection procedures and process record for the inner bearing assembly component in the HeartWare Ventricular Assist Device Pump.

Current openFDA PMA Record#

Device: HeartWare Ventricular Assist System
Applicant: Medtronic
PMA number: P100047
Supplement: S098
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 2017-06-27
Decision code: OK30
Date received: 2017-06-05
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Modification to the manufacturing and quality inspection procedures and process record for the inner bearing assembly component in the HeartWare Ventricular Assist Device Pump.