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: HEARTMATE II LVAS
• Generic Name: Ventricular (assist) bypass
• Applicant: ABBOTT MEDICAL; 6035 Stoneridge Dr.; Pleasanton, CA 94588
• PMA Number: P060040
• Supplement Number: S013
• Date Received: 09/17/2010
• Decision Date: 10/08/2010
• Product Code: DSQ
• Advisory Committee: Cardiovascular
• Supplement Type: Special (Immediate Track)
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
APPROVAL FOR REVISED OPERATOR MANUAL AND PATIENT HANDBOOK LABELING FOR THE DEVICE.