PMA P870072S030

Device: THORATEC IMPLANTABLE VENTRICULAR ASSIST DEVICE (IVAD)
Applicant: Thoratec Laboratories Corp.
PMA number: P870072
Supplement: S030
Product code: DSQ
Decision date: 2005-01-19
Classification: Ventricular (assist) Bypass
Generic name: Ventricular (assist) bypass
Approval order statement: APPROVAL FOR A MODIFIED IVAD TUNNELED PNEUMATIC FITTING AND TO ADD TWO (2) CANNULAE FOR THE IVAD DEVICE; IVAD CURVED SHORT ARTERIAL CANNULA AND IVAD SHORT VENTRICULAR CANNULA WITH 2 SIDE HOLES.

Current openFDA PMA Record#

Device: THORATEC IMPLANTABLE VENTRICULAR ASSIST DEVICE (IVAD)
Applicant: Thoratec Laboratories Corp.
PMA number: P870072
Supplement: S030
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 2005-01-19
Decision code: APPR
Date received: 2004-09-29
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A MODIFIED IVAD TUNNELED PNEUMATIC FITTING AND TO ADD TWO (2) CANNULAE FOR THE IVAD DEVICE; IVAD CURVED SHORT ARTERIAL CANNULA AND IVAD SHORT VENTRICULAR CANNULA WITH 2 SIDE HOLES.