PMA P870072S007

Device: THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM
Applicant: Thoratec Laboratories Corp.
PMA number: P870072
Supplement: S007
Product code: DSQ
Decision date: 1998-07-20
Classification: Ventricular (assist) Bypass
Generic name: Ventricular (assist) bypass
Approval order statement: Requested change in the supplier of the valves used to control the direction of blood flow in the Ventricular Assist Device. The supplier will be changed from Sorin biomedical in Irvine, California to Arrow International in Reading Pennsylvania.

Current openFDA PMA Record#

Device: THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM
Applicant: Thoratec Laboratories Corp.
PMA number: P870072
Supplement: S007
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 1998-07-20
Decision code: OK30
Date received: 1998-07-13
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Requested change in the supplier of the valves used to control the direction of blood flow in the Ventricular Assist Device. The supplier will be changed from Sorin biomedical in Irvine, California to Arrow International in Reading Pennsylvania.