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: S032
• Date Received: 08/12/2008
• Decision Date: 08/28/2008
• Product Code: MDS
• Advisory Committee: Clinical Chemistry
• Supplement Type: 30-Day Notice
• Expedited Review Granted?: No
• Combination Product: No
• Recalls: CDRH Recalls

Approval Order Statement  
CHANGES TO THE GLUCOSE SENSOR¿S COATING PROCESS.