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. |
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Device | t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM System |
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 | S028 |
Date Received | 01/16/2019 |
Decision Date | 03/01/2019 |
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 Introduce alternate suppliers for PCB and PCBA parts for the t:slim X2 Insulin Pump. The t:slim X2 Insulin Pump is a component of the Dexcom G5 Mobile CGM System. |
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