|
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 | S027 |
Date Received | 09/27/2018 |
Decision Date | 10/26/2018 |
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 Change the procedure for wake button replacement during PCBA refurbishment by discontinuing replacement of the wake button if it meets specific criteria and by transferring various reprogramming steps in-house. The wake button switch assemblies are components of the t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM and the t:slim Insulin Pump with Basal-IQ Technology. |