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: SynchroMed® Infusion System
• Generic Name: Pump, infusion, implanted, programmable
• Applicant: Medtronic, Inc.; 7000 Central Ave., NE; Minneapolis, MN 55432
• PMA Number: P860004
• Supplement Number: S385
• Date Received: 01/10/2022
• Decision Date: 03/14/2023
• Product Code: LKK
• Advisory Committee: General Hospital
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Change Design/Components/Specifications/Material
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval with conditions for Medtronics updated use of third party applications on the CT900 and HH90 devices.