PMA P870072S022

Device: THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM
Applicant: Thoratec Laboratories Corp.
PMA number: P870072
Supplement: S022
Product code: DSQ
Decision date: 2002-10-29
Classification: Ventricular (assist) Bypass
Generic name: Ventricular (assist) bypass
Approval order statement: APPROVAL FOR THE ADDITION OF INSPECTIONS, TEST METHODS, AND SPECIFICATIONS FOR THE CONTROLLER BOARDS FOR THE TLC-II PORTABLE VAD DRIVER.

Current openFDA PMA Record#

Device: THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM
Applicant: Thoratec Laboratories Corp.
PMA number: P870072
Supplement: S022
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 2002-10-29
Decision code: APPR
Date received: 2002-09-30
Supplement type: Special (Immediate Track)
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR THE ADDITION OF INSPECTIONS, TEST METHODS, AND SPECIFICATIONS FOR THE CONTROLLER BOARDS FOR THE TLC-II PORTABLE VAD DRIVER.