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.
 
Devicet:slim X2 Insulin Pump with Basal-IQ Technology
Generic NameAutomated insulin dosing , threshold suspend
ApplicantTandem Diabetes Care, Inc.
11075 Roselle St.
San Diego, CA 92121
PMA NumberP180008
Supplement NumberS005
Date Received09/12/2018
Decision Date10/11/2018
Product Codes OZO PQF 
Advisory Committee Clinical Chemistry
Clinical TrialsNCT03195140
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Removal of plasma treatment on the patient line, modification to the final packing verification process, and the addition of additional testing/acceptance criteria for the pumps. The Tandem cartridges and pumps are part of the Tandem t:slim X2 Insulin Pump system.
  We welcome your comments and feedback about Devices@FDA.
-
-