FDA CITES MEDTRONIC FOR MISSING FILING DEADLINE
Medtronic Vascular violated federal regulations by failing to submit an interim postmarket surveillance report on time, the FDA said in a Sept. 27 warning letter.
As of the warning letter date, the firm had still failed to submit the interim postmarket surveillance report due May 31 for an unnamed endovascular graft system used to treat abdominal aortic aneurysms (AAAs). Medtronic said the device is the AneuRx stent graft system.
An AAA results when a weak area causes a bulge in the abdominal part of the aorta, the main artery that carries blood from the heart to the rest of the body. An endovascular graft is a woven fabric tube that strengthens the artery to keep the bulge from bursting.
Medtronic's approved postmarket surveillance plan, modified by the FDA upon the firm's request Aug. 9, 2005, required annual submission of interim reports beginning May 31, the letter said.
A firm's devices can be labeled "misbranded" if a firm fails to adhere to regulations requiring manufacturers to submit approved postmarket surveillance plans to the FDA in a timely manner, the letter said.
The warning letter "is not related to the quality, design or manufacture of the AneuRx product," the firm said Sept. 29. The AneuRx system, which has been commercially approved since 1999, has a proven safety record and "is among the most implanted AAA devices on the market," the firm said.