PMA P870072S024

Device: THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM
Applicant: Thoratec Laboratories Corp.
PMA number: P870072
Supplement: S024
Product code: DSQ
Decision date: 2002-12-31
Classification: Ventricular (assist) Bypass
Generic name: Ventricular (assist) bypass
Approval order statement: APPROVAL FOR THE ADDITION OF A WARNING STATEMENT TO THE PACKAGE LABELS AND TO THE INSTRUCTIONS FOR USE FOR THE BEVELED-TIP ATRIAL CANNULA, AS USED WITH THE THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM.

Current openFDA PMA Record#

Device: THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM
Applicant: Thoratec Laboratories Corp.
PMA number: P870072
Supplement: S024
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 2002-12-31
Decision code: APPR
Date received: 2002-12-11
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR THE ADDITION OF A WARNING STATEMENT TO THE PACKAGE LABELS AND TO THE INSTRUCTIONS FOR USE FOR THE BEVELED-TIP ATRIAL CANNULA, AS USED WITH THE THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM.