Premarket Approval (PMA)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.

• Trade Name: GUARDIAN RT
• Classification Name: sensor, glucose, invasive
• Generic Name: continuous subcutaneous glucose monitoring system
• Applicant: MEDTRONIC MINIMED
• PMA Number: P980022
• Supplement Number: S014
• Date Received: 12/27/2005
• Decision Date: 12/27/2006
• Product Code: MDS [ Registered Establishments with MDS ]
• Advisory Committee: Clinical Chemistry
• Supplement Type: normal 180 day track no user fee
• Supplement Reason: postapproval protocol or modification to a protocol
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval of the post-approval study.