PMA P920014S013

Device: TCI HEARTMATE VE LVAS
Applicant: Thoratec Corp
PMA number: P920014
Supplement: S013
Product code: DSQ
Decision date: 2000-10-20
Generic name: Ventricular (assist) bypass
Approval order statement: APPROVAL TO MODIFY THE HEARTMATE VE SYSTEM CONTROLLER (C/N 1215) TO ACCOMODATE A NEW FOUR CELL BATTERY MODULE (BATTERY CELL), RESULTING IN VE SYSTEM CONTROLLER C/N 1216 AND BATTERY MODULE C/N 1264.

Current openFDA PMA Record

Device: TCI HEARTMATE VE LVAS
Applicant: Thoratec Corp
PMA number: P920014
Supplement: S013
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 2000-10-20
Decision code: APPR
Date received: 2000-09-15
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL TO MODIFY THE HEARTMATE VE SYSTEM CONTROLLER (C/N 1215) TO ACCOMODATE A NEW FOUR CELL BATTERY MODULE (BATTERY CELL), RESULTING IN VE SYSTEM CONTROLLER C/N 1216 AND BATTERY MODULE C/N 1264.