FDA POSTS INFORMATION ON TWO NEWLY APPROVED DEVICES

The FDA Aug. 15 posted information on two recently approved devices. The GORE Helex septal occluder was approved Aug. 11. The device is used to close atrial septal defects (ASDs) -- abnormal holes in the septum, the wall of tissue separating the right and left atria of the heart. The PRODISC-L total disc replacement was approved Aug. 14. The device is an artificial spine implant to treat the pain associated with degenerative disc disease (DDD).

FDA (http://www.fda.gov/cdrh/mda/docs/p050006.html)