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: GUARDIAN RT CONTINUOUS GLUCOSE MONITORING SYSTEM
• Generic Name: Sensor, glucose, invasive
• Applicant: MEDTRONIC MINIMED; 18000 DEVONSHIRE ST; NORTHRIDGE, CA 91325
• PMA Number: P980022
• Supplement Number: S011
• Date Received: 08/20/2004
• Decision Date: 07/18/2005
• Product Code: MDS
• Docket Number: 05M-0454
• Notice Date: 11/15/2005
• Advisory Committee: Clinical Chemistry
• Supplement Type: Panel Track
• Expedited Review Granted?: Yes
• Combination Product: No
• Recalls: CDRH Recalls

Approval Order Statement  
APPROVAL FOR THE GUARDIAN RT. THE DEVICE IS INDICATED FOR CONTINUOUS OR PERIODIC MONITORING OF GLUCOSE LEVELS IN THE FLUID UNDER THE SKIN IN ADULTS (AGES 18 AND OLDER) WITH DIABETES MELLITUS FOR THE PURPOSE OF IMPROVING DIABETES MANAGEMENT. IT ALERTS IF A GLUCOSE LEVEL FALLS BELOW OR RISES ABOVE PRESET VALUES. VALUES ARE NOT INTENDED TO BE USED DIRECTLY FOR MAKING THERAPY ADJUSTMENTS, BUT RATHER TO PROVIDE AN INDICATION OF WHEN A FINGER STICK MAY BE REQUIRED. ALL THERAPY ADJUSTMENTS WOULD BE BASED ON MEASUREMENTS OBTAINED USING A HOME GLUCOSE MONITOR AND NOT ON GUARDIAN VALUES. GUARDIAN RT PROVIDES REAL-TIME GLUCOSE VALUES THAT ALLOW USERS TO TRACK PATTERNS IN GLUCOSE CONCENTRATIONS AND TO POSSIBLY IDENTIFY EPISODES OF LOW AND HIGH BLOOD GLUCOSE EPISODES. IT ALSO STORES THE DATA SO THAT IT CAN BE ANALYZED TO TRACK PATTERNS. GLUCOSE DATA CAN BE FURTHER DOWNLOADED TO PC SOFTWARE FOR ANALYSIS OF HISTORICAL GLUCOSE VALUES.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling