Warning Letter Troubles Delay Approval of Medtronic Devices

Besides causing enforcement headaches, warning letters can prove to be quite costly. That’s the lesson Medtronic is learning as an unresolved warning letter is stopping the launch of two new devices. The U.S. approvals of Medtronic’s Protecta defibrillators and Revo MRI SureScan pacing system have been delayed due to a year-old warning letter for its Mounds View, Minn., facility. The FDA conducted a follow-up inspection of the cardiac rhythm management unit this past September, but it has yet to give the company a closeout letter, spokesman Christopher Garland said.
Devices & Diagnostics Letter