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: DEXCOM SEVEN AND SEVEN PLUS
• Classification Name: sensor, glucose, invasive
• Applicant: DEXCOM, INC.
• PMA Number: P050012
• Supplement Number: S030
• Date Received: 07/30/2010
• Decision Date: 09/09/2010
• Product Code: MDS [ Registered Establishments with MDS ]
• Advisory Committee: Clinical Chemistry
• Supplement Type: real-time process
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval for modification to the sensor needle carrier to reduce force required to release snaps during cannula retraction.