The Food & Drug Administration lifted its remaining holds on defibrillators made by Boston Scientific Corp. (NYSE:BSX), more than two months after the medical devices giant stopped all shipments after a filing snafu with the FDA.
The Natick, Mass.-based firm altered its manufacturing practices for the devices, but failed to notify the FDA regarding the changes, resulting in the holds.
Boston Scientific sent letters to patients and doctors to inform them that the devices are now available and reiterating their safety, according to a securities filing.
The debacle began March 15, when the company began holding all shipments of its implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators and pulled all inventory from the field after discovering that it missed a pair of filings with the federal watchdog agency. BSX said it failed to notify the FDA of two changes to its manufacturing process for its Cognis, Confient, Livian, Prizm, Renewal, Teligen and Vitality ICDs and CRT-Ds. The changes were “successfully validated” and posed no risk to patient safety, the company said.
Two of the devices were cleared to resume sales April 16. The latest action clears the hold on the remaining devices.