Tandem Diabetes Care Inc (TNDM)

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TNDM from latest 8K:
http://ih.advfn.com/p.php?pid=nmona&article=75526011
Item 8.01 Other Events

On August 25, 2017, the U.S. Food and Drug Administration (FDA) approved our pre-market application (PMA) for the t:slim X2 Insulin Pump with Dexcom G5 ® Mobile continuous glucose monitoring (CGM) integration. The software featured on this newly approved pump will also be offered to current t:slim X2 Pump users at no cost via remote software update, allowing them to add CGM integration to their existing t:slim X2 Pumps from home using a personal computer. The t:slim X2 Pump with Dexcom G5 Mobile CGM integration is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin for individuals 6 years of age and greater.

On August 28, 2017 we issued a press release announcing the FDA approval and commercial launch of the t:slim X2 Insulin Pump with Dexcom G5 Mobile integration.