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: Paradigm REAL-Time Revel Insulin Pump with Enlite Sensor System
• Generic Name: Sensor, glucose, invasive
• Applicant: Medtronic Minimed; 18000 Devonshire St.; Northridge, CA 91325
• PMA Number: P150019
• Supplement Number: S022
• Date Received: 09/30/2016
• Decision Date: 10/13/2016
• Product Codes: MDS OYC
• Advisory Committee: Clinical Chemistry
• Supplement Type: Real-Time Process
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for a modification to the design of the drive support cap of the Paradigm insulin pump.