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 II, Ventricular Assist System
• Generic Name: Ventricular (assist) bypass
• Applicant: ABBOTT MEDICAL; 6035 Stoneridge Dr.; Pleasanton, CA 94588
• PMA Number: P060040
• Supplement Number: S067
• Date Received: 07/19/2017
• Decision Date: 08/17/2017
• Product Code: DSQ
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Implement the use of a secondary supplier of three silicone components of the HeartMate II LVAS.