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: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
• Generic Name: Sensor, glucose, invasive
• Applicant: DEXCOM, INC.; 6340 SEQUENCE DR; SAN DIEGO, CA 92121
• PMA Number: P120005
• Supplement Number: S010
• Date Received: 07/26/2013
• Decision Date: 08/19/2013
• 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

Approval Order Statement  
ADDITION OF A -20°C UPRIGHT LABORATORY FREEZER TO THE SENSOR MANUFACTURING EQUIPMENT.