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: S395
• Date Received: 07/22/2022
• Decision Date: 08/19/2022
• Product Code: LKK
• Advisory Committee: General Hospital
• Supplement Type: Special (Immediate Track)
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for labeling changes to the Catheter Access Port Kit of the SynchroMed Infusion System.