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: Impella 5.5 with SmartAssist
• Generic Name: Temporary non-roller type left heart support blood pump
• Applicant: Abiomed, Inc.; 22 Cherry Hill Dr.; Danvers, MA 01923
• PMA Number: P140003
• Supplement Number: S119
• Date Received: 09/25/2024
• Decision Date: 10/21/2024
• Product Code: OZD
• 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  
for a second supplier of the integrated patient cable of the Impella 5.5 with SmartAssist