PMA P100047S031

Device: HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM
Applicant: Medtronic
PMA number: P100047
Supplement: S031
Product code: DSQ
Decision date: 2013-10-30
Classification: Ventricular (assist) Bypass
Generic name: Ventricular (assist) bypass
Approval order statement: MODIFICATION OF THE IN-PROCESS VISUAL INSPECTION AND ADDITION OF A VARIABLE INSPECTION METHOD FOR TWO DEVICE COMPONENTS WHICH ARE PART OF THE HEARTWARE® VENTRICULAR ASSIST SYSTEM.

Current openFDA PMA Record#

Device: HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM
Applicant: Medtronic
PMA number: P100047
Supplement: S031
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 2013-10-30
Decision code: OK30
Date received: 2013-09-30
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: MODIFICATION OF THE IN-PROCESS VISUAL INSPECTION AND ADDITION OF A VARIABLE INSPECTION METHOD FOR TWO DEVICE COMPONENTS WHICH ARE PART OF THE HEARTWARE® VENTRICULAR ASSIST SYSTEM.