Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: THORATEC HEARTMATE LEFT VENTRICULAR ASSIST SYSTEM (SNAP VE LVAS)
• Generic Name: Ventricular (assist) bypass
• Applicant: THORATEC CORP.; 6035 STONERIDGE DR.; PLEASANTON, CA 94588
• PMA Number: P920014
• Supplement Number: S016
• Date Received: 10/16/2001
• Decision Date: 11/06/2002
• Withdrawal Date: 10/03/2014
• Product Code: DSQ
• Advisory Committee: Cardiovascular
• Supplement Type: Panel Track
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: Yes
• Combination Product: No

Approval Order Statement  
APPROVAL FOR AN EXPANDED INDICATION FOR USE FOR THE THORATEC HEARTMATE SNAP VE LVAS. THE DEVICE IS INDICATED FOR USE AS A BRIDGE TO CARDIAC TRANSPLANTATION IN CARDIAC TRANSPLANT CANDIDATES AT RISK OF IMMINENT DEATH FROM NONREVERSIBLE LEFT VENTRICULAR FAILURE. IT IS NOW ALSO INDICATED FOR USE IN PATIENTS WITH NEW YORK HEART ASSOCIATION CLASS IV END STAGE LEFT VENTRICULAR FAILURE WHO HAVE RECEIVED OPTIMAL MEDICAL THERAPY FOR AT LEAST 60 OF THE LAST 90 DAYS, AND WHO HAVE A LIFE EXPECTANCY OF LESS THAN TWO YEARS, AND WHO ARE NOT ELIGIBLE FOR CARDIAC TRANSPLANTATION. THE DEVICE SYSTEM IS APPROVED FOR USE BOTH INSIDE AND OUTSIDE OF THE HOSPITAL.

• Approval Order: Approval Order
• Post-Approval Study: Show Report Schedule and Study Progress