• 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
 


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.
 
DeviceEversense Continuous Glucose Monitoring System
Classification Namecontinuous glucose monitor, implanted, adjunctive use
Generic Namecontinuous glucose monitor, implanted, adjunctive use
Applicant
Senseonics, Incorporated
20451 seneca meadows parkway
germantown, MD 20876-7005
PMA NumberP160048
Supplement NumberS008
Date Received12/11/2018
Decision Date01/28/2019
Product Code
QCD[ Registered Establishments with QCD ]
Advisory Committee Clinical Chemistry
Supplement Typereal-time process
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to label the Eversense Sensor as Magnetic Resonance (MR) Conditional.
-
-