PMA P100047S022

Device: HEART WARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM
Applicant: Medtronic
PMA number: P100047
Supplement: S022
Product code: DSQ
Decision date: 2013-07-03
Classification: Ventricular (assist) Bypass
Generic name: Ventricular (assist) bypass
Approval order statement: APPROVAL FOR UPDATES TO THE INSTRUCTIONS FOR USE AND PATIENT MANUAL OF THE DEVICE TO INCLUDE WARNINGS AND INFORMATION RELATED TO ELECTROSTATIC DISCHARGE EXPOSURE AND EXCHANGING POWER SOURCES.

Current openFDA PMA Record#

Device: HEART WARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM
Applicant: Medtronic
PMA number: P100047
Supplement: S022
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 2013-07-03
Decision code: APPR
Date received: 2013-05-31
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR UPDATES TO THE INSTRUCTIONS FOR USE AND PATIENT MANUAL OF THE DEVICE TO INCLUDE WARNINGS AND INFORMATION RELATED TO ELECTROSTATIC DISCHARGE EXPOSURE AND EXCHANGING POWER SOURCES.