PMA P100047S077

Device: HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM
Applicant: Medtronic
PMA number: P100047
Supplement: S077
Product code: DSQ
Decision date: 2016-12-13
Classification: Ventricular (assist) Bypass
Generic name: Ventricular (assist) bypass
Approval order statement: Approval for print changes, content revision and the addition of an alternate manufacturer for the HeartWare Ventricular Assist System (HVAS) Patient Manual, Instructions for Use and Emergency Responders Guide.

Current openFDA PMA Record#

Device: HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM
Applicant: Medtronic
PMA number: P100047
Supplement: S077
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 2016-12-13
Decision code: APPR
Date received: 2016-06-17
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for print changes, content revision and the addition of an alternate manufacturer for the HeartWare Ventricular Assist System (HVAS) Patient Manual, Instructions for Use and Emergency Responders Guide.