PMA P100047S029

Device: HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM
Applicant: Medtronic
PMA number: P100047
Supplement: S029
Product code: DSQ
Decision date: 2013-09-06
Classification: Ventricular (assist) Bypass
Generic name: Ventricular (assist) bypass
Approval order statement: REPLACEMENT OF THE CURRENT STERILIZATION PROCESS CHALLENGE DEVICE WITH AN ALTERNATIVE PROCESS CHALLENGE DEVICE FOR MONITORING OF ETHYLENE OXIDE STERILIZED COMPONENTS OF THE DEVICE.

Current openFDA PMA Record#

Device: HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM
Applicant: Medtronic
PMA number: P100047
Supplement: S029
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 2013-09-06
Decision code: OK30
Date received: 2013-08-07
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: REPLACEMENT OF THE CURRENT STERILIZATION PROCESS CHALLENGE DEVICE WITH AN ALTERNATIVE PROCESS CHALLENGE DEVICE FOR MONITORING OF ETHYLENE OXIDE STERILIZED COMPONENTS OF THE DEVICE.