An FDA warning letter to Medtronic (NYSE:MDT), revealed earlier today along with pre-market approval for the MiniMed 530G artificial pancreas, concerned the medical device company’s Northridge, Calif., diabetes facility, a spokeswoman told MassDevice.com today.
The warning letter, received Sept. 19, concerned procedures covering "corrective and preventative action, complaint handling processes, process validation, process monitoring, design control and general good manufacturing processes," according to an emailed statement from Amanda Sheldon, director of public relations for Medtronic’s diabetes division.
"The warning letter acknowledges the extensive work we have already completed to address many of the observations noted by the FDA. The company will respond with additional steps that will be taken to address any concerns raised as quickly as possible," Sheldon wrote. "It is important for patients and physicians to know that we stand behind the quality of our products and that no action is presently required by patients or physicians related to this letter. We take these findings seriously and are working closely with the FDA. Medtronic is committed to quality and patient safety and are committed to continuously improving our quality processes."
Earlier today Medtronic said the FDA granted pre-market approval for its 1st-generation artificial pancreas device, the MiniMed 530G with Enlite. Medtronic claimed the device as the 1st such system in the U.S. with the ability to stop halt glucose delivery at a preset level. The PMA nod, for diabetics age 16 and older.
The Fridley, Minn.-based company said the MiniMed 530G PMA approval includes a commitment to "engage in direct patient follow-up" and "make certain manufacturing accommodations."