Premarket Approval (PMA)

Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.

• Trade Name: DEXCOM G4 PLATINUM CONTIUOUS GLUCOSE MONITORING SYSTEM
• Classification Name: sensor, glucose, invasive
• Applicant: DEXCOM, INC.
• PMA Number: P120005
• Date Received: 04/09/2012
• Decision Date: 10/05/2012
• Product Code: MDS [ Registered Establishments with MDS ]
• Docket Number: 12M-1049
• Notice Date: 10/12/2012
• Advisory Committee: Clinical Chemistry
• Clinical Trials: NCT01514292
• Expedited Review Granted?: No
• Combination Product: No
• Information About: Labeling, Approval Order, Summary of Safety and Effectiveness

Approval Order Statement 
Approval for the dexcom g4 platinum continuous glucose monitoring system. This device is indicated for: the dexcom g4 platinum continuous glucose monitoring system is a glucose monitoring device indicated for detecting trends and tracking patterns in persons (age 18 and older) with diabetes. The system is intended for single patient use and requires a prescription. The dexcom g4 platinum system is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home glucose monitoring devices. The dexcom g4 platinum system aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments, which may minimize these excursions. Interpretation of the dexcom g4 platinum system results should be based on the trends and patterns seen with several sequential readings over time.

Approval Order

Approval Order

• Supplements: S001 S003 S004