MiniMed 530G Warning Letter
important safety information
On September 19, 2013 Medtronic received a warning letter from the U.S. Food and Drug Administration. We have been working closely with the FDA to determine the appropriate steps to address the warning letter and the FDA has granted approval for the MiniMed 530G.
This is a letter sent to Medtronic; no action is presently required by patients or physicians related to this letter.
Please know that we take these findings very seriously. Medtronic has been working very closely with the FDA. We have already addressed many of the observations noted in the warning letter, and we are committed to resolving the remaining observations as quickly as possible. We want to ensure you that we are committed to providing safe and effective products for people with diabetes.