PMA P870072S031

Device: THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM
Applicant: Thoratec Laboratories Corp.
PMA number: P870072
Supplement: S031
Product code: DSQ
Decision date: 2004-11-17
Classification: Ventricular (assist) Bypass
Generic name: Ventricular (assist) bypass
Approval order statement: CHANGE IN TH JOINING PROCESS FOR THE PARACORPOREAL VENTRICULAR ASSIST DEVICE (PVAD) CASE FITTINGS AND A CHANGE FROM A MACHINING PROCESS TO AN INJECTION MOLDING PROCESS FOR THE MANUFACTURE OF PVAD COMPONENTS.

Current openFDA PMA Record#

Device: THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM
Applicant: Thoratec Laboratories Corp.
PMA number: P870072
Supplement: S031
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 2004-11-17
Decision code: OK30
Date received: 2004-10-28
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE IN TH JOINING PROCESS FOR THE PARACORPOREAL VENTRICULAR ASSIST DEVICE (PVAD) CASE FITTINGS AND A CHANGE FROM A MACHINING PROCESS TO AN INJECTION MOLDING PROCESS FOR THE MANUFACTURE OF PVAD COMPONENTS.