PMA P060040S022

Device: THORATEC HEARTMATE II LVAS
Applicant: ABBOTT MEDICAL
PMA number: P060040
Supplement: S022
Product code: DSQ
Decision date: 2012-07-05
Classification: Ventricular (assist) Bypass
Generic name: Ventricular (assist) bypass
Approval order statement: APPROVAL FOR CHANGES TO THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) REGARDING DISCONTINUATION OF THE EMERGENCY POWER PACK (EPP) AND SOME MINOR LABELING MODIFICATIONS.

Current openFDA PMA Record#

Device: THORATEC HEARTMATE II LVAS
Applicant: ABBOTT MEDICAL
PMA number: P060040
Supplement: S022
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 2012-07-05
Decision code: APPR
Date received: 2012-05-17
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR CHANGES TO THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) REGARDING DISCONTINUATION OF THE EMERGENCY POWER PACK (EPP) AND SOME MINOR LABELING MODIFICATIONS.