This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: : PRESTIGE® Cervical Disc System
PMA Applicant: Medtronic Sofamor Danek
Address: 1800 Pyramid Place, Memphis, TN 38132
Approval Date: : July 16, 2007
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf6/p060018a.pdf
What is it? The PRESTIGE® Cervical Disc System is a two-piece metal device that is attached to adjacent vertebral bodies (neck bones) with bone screws to replace a diseased cervical disc.
How does it work? Once the diseased disc is removed, the PRESTIGE® Cervical Disc System is attached to the adjacent vertebral bodies with bone screws. The device consists of two main metal pieces, superior (upper) and inferior (lower) parts, that move with respect to one another by a ball and trough mechanism.
When is it used? The PRESTIGE® Cervical Disc System is intended to be used to replace a cervical disc from C3-C7 following removal of the disc for intractable radiculopathy and/or myelopathy (conditions that result from a diseased or bulging disc).
What will it accomplish? The device should help stabilize the operated spinal level. Unlike a fusion procedure, the PRESTIGE® Cervical Disc System is designed to allow motion at the operated spinal level. The effects of the diseased disc removal should include pain relief and improved function.
When should it not be used? The PRESTIGE® Cervical Disc System should not be implanted in patients with an active infection or with an allergy to stainless steel.
Additional information: The Summary of Safety and Effectiveness and labeling are available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p060018