• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections

New Search Back to Search Results
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.
Classification Namesensor, glucose, invasive
ApplicantDEXCOM, INC.
PMA NumberP120005
Supplement NumberS036
Date Received05/14/2015
Decision Date07/02/2015
Product Code
MDS[ Registered Establishments with MDS ]
Advisory Committee Clinical Chemistry
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for software modifications to the existing firmware update tool to allow the tool to be run on mac os x operating systems, to improve the runtime and simplify installation steps on currently supported windows platforms, to add notifications which alert users compatibility issues with usb 3. 0 ports, and to improve compatibility with future dexcom products. The device, as modified, will be marketed under the trade name dexcom g4 platinum continuous glucose monitoring system and is 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.