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: MEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM
• Generic Name: Sensor, glucose, invasive
• Applicant: Medtronic Minimed; 18000 Devonshire St.; Northridge, CA 91325
• PMA Number: P980022
• Supplement Number: S035
• Date Received: 09/17/2008
• Decision Date: 10/02/2008
• Product Code: MDS
• Advisory Committee: Clinical Chemistry
• 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  
CHANGE TO THE STERILIZATION PROCESS OF THE GLUCOSE SENSOR'S ADHESION PATCH.