Synthes receives Approvable Letter from FDA for Prodisc-C (cervical) Total Disc Replacement
Synthes received on October 25 2007 an Approvable Letter from the U.S. Food and Drug Administration (FDA) regarding the Prodisc-C Total Disc Replacement. The Pre-Market Approval (PMA) request was submitted to the FDA in January 2007.
The letter means that the FDA has concluded its review of the Prodisc-C PMA and has determined that the device is safe and effective for use in replacing a diseased and/or degenerated intervertebral disc of the cervical spine in patients with symptomatic cervical disc disease (SCDD). The Prodisc-C Total Disc Replacement procedure is intended to significantly reduce pain by allowing for the removal of the diseased disc while restoring disc height and providing the potential for motion at the affected vertebral segment.
