Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Devices@FDA
  • Print
  • Share
  • E-mail
-
 
Help | Download Files | More about PMA

New Search Back to Search Results
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.
 
DeviceDEXCOM STS SYSTEM
Generic NameSensor, glucose, invasive
ApplicantDexcom, Inc.
5555 Oberlin Dr.
San Diego, CA 92121
PMA NumberP050012
Supplement NumberS002
Date Received07/28/2006
Decision Date08/21/2006
Withdrawal Date08/28/2015
Product Code MDS 
Advisory Committee Clinical Chemistry
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR DESIGN REVISIONS TO THE ACCESSORY SOFTWARE PROGRAM TO ENABLE IT TO BE USED FOR CONSUMER USE. THE SOFTWARE PROGRAM, AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAME DEXCOM DM-CONSUMER AND IS INDICATED FOR USE BY CONSUMERS TO ALLOW FOR THE TRANSFER OF GLUCOSE DATA STORED BY THE DEXCOM STS SYSTEM INTO A PERSONAL COMPUTER.
  We welcome your comments and feedback about Devices@FDA.
-
-