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: HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM
• Generic Name: Ventricular (assist) bypass
• Applicant: Medtronic; 8200 Coral Sea St. N.E; Mounds View, MN 55112
• PMA Number: P100047
• Supplement Number: S079
• Date Received: 08/03/2016
• Decision Date: 09/01/2016
• 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  
Implementation of an alternate automated option for the Taylor Hobson Profilometer.