PMA P870072S003

Device: THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM
Applicant: Thoratec Laboratories Corp.
PMA number: P870072
Supplement: S003
Product code: DSQ
Decision date: 1997-04-17
Classification: Ventricular (assist) Bypass
Generic name: Ventricular (assist) bypass
Approval order statement: APPROVAL FOR ADDING AN ALTERNATE CONTRACT STERILIZER FACILITY, AND CHANGING THE MATERIAL AND CONFIGURATION OF THE STORAGE BOX FOR THE PUMPS AND CANNULAE

Current openFDA PMA Record#

Device: THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM
Applicant: Thoratec Laboratories Corp.
PMA number: P870072
Supplement: S003
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 1997-04-17
Decision code: APPR
Date received: 1996-10-18
Supplement type: Normal 180 Day Track
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR ADDING AN ALTERNATE CONTRACT STERILIZER FACILITY, AND CHANGING THE MATERIAL AND CONFIGURATION OF THE STORAGE BOX FOR THE PUMPS AND CANNULAE