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.
 
DeviceMiniMed 670G System
Generic NameAutomated insulin dosing device system, single hormonal control
ApplicantMedtronic Minimed, Inc.
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP160017
Supplement NumberS045
Date Received06/19/2018
Decision Date07/16/2018
Product Code OZP 
Advisory Committee Clinical Chemistry
Clinical TrialsNCT02130284
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
Relocating the molding process to a new manufacturing location and adding replacement presses and new molds for the needle hub assembly parts of the Enlite 3 Sensor and the Guardian Sensor (3). The Guardian Sensor (3) is a component of the MiniMed 670G, the Guardian Connect, and the MiniMed 630G System. The Enlite 3 Sensor is a component of the MiniMed iPro 2, MiniMed Paradigm Real-Time Revel, MiniMed 530G, and MiniMed 630G Systems.
Post-Approval StudyShow Report Schedule and Study Progress
  We welcome your comments and feedback about Devices@FDA.
-
-