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: Implantable System for Remodulin
• Generic Name: Pump, infusion, implanted, programmable
• Applicant: Medtronic, Inc.; 710 Medtronic Pkwy. NE; Minneapolis, MN 55432
• PMA Number: P140032
• Supplement Number: S018
• Date Received: 08/08/2018
• Decision Date: 06/14/2019
• Withdrawal Date: 08/18/2021
• Product Code: LKK
• Advisory Committee: General Hospital
• Supplement Type: 135 Review Track For 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for a change in the external supplier lithium source and an addition of a lithium purification process step.