FDA ORTHOPEDIC PANEL TO MEET ON PMA APPLICATION FOR DEVICE TO TREAT DEGENERATIVE DISC DISEASE

The FDA announced Aug. 22 the agency's Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee will meet Sept. 19.

The committee will discuss, make recommendations and vote on a premarket approval (PMA) application for a cervical disc prosthesis intended to treat skeletally mature patients with degenerative disc disease, the agency said.

Written submissions may be made on or before Sept. 5, the FDA said.

The notice can be viewed at www.fda.gov/OHRMS/DOCKETS/98fr/2006-4243-nm00001.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/2006-4243-nm00001.pdf).