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. |
|
Device | t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM |
Generic Name | Pump, infusion, insulin, to be used with invasive glucose sensor |
Applicant | Tandem Diabetes Care, Inc. 11045 Roselle Street San Diego, CA 92121 |
PMA Number | P140015 |
Supplement Number | S026 |
Date Received | 09/12/2018 |
Decision Date | 10/11/2018 |
Product Codes |
MDS OYC |
Advisory Committee |
Clinical Chemistry |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
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. |
|
|