PMA P920014S023

Device: THORATEC HEARTMATE XVE AND VE LEFT VENTRICULAR ASSIST SYSTEM (LVAS)
Applicant: Thoratec Corp
PMA number: P920014
Supplement: S023
Product code: DSQ
Decision date: 2004-07-08
Generic name: Ventricular (assist) bypass
Approval order statement: APPROVAL FOR USE OF THE POWERSONIC SEALED LEAD ACID BATTERY (MODEL PS-1223) AS A REPLACEMENT FOR THE NO LONGER MANUFACTURED PANASONIC SEALED LEAD ACID BATTERY (MODEL LC-SA122R3EU) AS A SOURCE OF BATTERY POWER TO DRIVE THE HEARTMATE VE AND ZVE LEFT VENTRICULAR ASSIST SYSTEMS.

Current openFDA PMA Record#

Device: THORATEC HEARTMATE XVE AND VE LEFT VENTRICULAR ASSIST SYSTEM (LVAS)
Applicant: Thoratec Corp
PMA number: P920014
Supplement: S023
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 2004-07-08
Decision code: APPR
Date received: 2004-01-09
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR USE OF THE POWERSONIC SEALED LEAD ACID BATTERY (MODEL PS-1223) AS A REPLACEMENT FOR THE NO LONGER MANUFACTURED PANASONIC SEALED LEAD ACID BATTERY (MODEL LC-SA122R3EU) AS A SOURCE OF BATTERY POWER TO DRIVE THE HEARTMATE VE AND ZVE LEFT VENTRICULAR ASSIST SYSTEMS.