PMA P870072S028

Device: THORATEC PARACORPOREAL VENTRICULAR ASSIST DEVICE (PVAD) SYSTEM AND TLC-II PORTABLE VAD DRIVER
Applicant: Thoratec Laboratories Corp.
PMA number: P870072
Supplement: S028
Product code: DSQ
Decision date: 2004-08-03
Classification: Ventricular (assist) Bypass
Generic name: Ventricular (assist) bypass
Approval order statement: APPROVAL FOR A MODIFICATION TO THE CIRCUITRY ASSOCIATED WITH THE BATTERY SUPERVISOR CHIP USED IN THE BATTERY PACKS THAT PROVIDE POWER FOR THE TLC-II PORTABLE PNEUMATIC DRIVER.

Current openFDA PMA Record#

Device: THORATEC PARACORPOREAL VENTRICULAR ASSIST DEVICE (PVAD) SYSTEM AND TLC-II PORTABLE VAD DRIVER
Applicant: Thoratec Laboratories Corp.
PMA number: P870072
Supplement: S028
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 2004-08-03
Decision code: APPR
Date received: 2004-03-03
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A MODIFICATION TO THE CIRCUITRY ASSOCIATED WITH THE BATTERY SUPERVISOR CHIP USED IN THE BATTERY PACKS THAT PROVIDE POWER FOR THE TLC-II PORTABLE PNEUMATIC DRIVER.