• 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 NumberS009
Date Received05/28/2019
Decision Date06/26/2019
Product Code
QCD[ Registered Establishments with QCD ]
Advisory Committee Clinical Chemistry
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Increased load size for a previously approved sterilization method, as well as approval for a new sealing device for the sterile barrier of the sensor component of the Eversense CGM system.
-
-