Advanced Spine receives FDA notification that its PMA application has been accepted for filing.IRVINE, Calif.--(HealthWire)--Sept. 17, 1996--Advanced Spine Fixation Systems Inc., an emerging Southern California Southern California, also colloquially known as SoCal, is the southern portion of the U.S. state of California. Centered on the cities of Los Angeles and San Diego, Southern California is home to nearly 24 million people and is the nation's second most populated region, based orthopedic device company that specializes in innovative spinal implants, confirmed today that it has received notification from the Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) that its Premarket Approval premarket approval Medical devices A scientific and regulatory review by the FDA to ensure the safety and effectiveness of a Class III device, before its approval for marketing. See Advisory panel, Medical device. (PMA PMA (papillary-marginal-attached), n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation. PMA Progressive muscular atrophy ) application, for a pedicle pedicle /ped·i·cle/ (ped´i-k'l) a footlike, stemlike, or narrow basal part or structure. ped·i·cle n. 1. A constricted portion or stalk. 2. screw system for the indication of degenerative disc disease Degeneration of the intervertebral disc, which is often called "degenerative disc disease" (DDD) of the spine, is a common disorder of the lower spine and for some people can cause low back pain and/or leg pain (sciatica). , has met the threshold determination that the PMA is sufficiently complete to permit a substantive review and is therefore suitable for filing. The official filing date was recorded as July 2, 1996. "The acceptance of our PMA application for filing is another milestone for the company in a turnaround year marked by strategic achievements in market direction and significant product advancements," said William E. Maya, chairman and chief executive officer of Advanced Spine. "Although the timing of the PMA approval process is unpredictable, this could be the first pedicle screw approved for the indications of degenerative disc disease. We are pleased with the FDA's response." Earlier this year, the company also received FDA clearance to market its newest spinal implant system, Varigrip(tm), which allows multi-directional stability without pedicle screws. Varigrip(tm) can also interact with the Varifix(r) System, extending the points of attachment through the thoracic spine. Advanced Spine designs, develops, manufactures and markets worldwide, advanced spinal implants and instrumentation for the surgical treatment of various spinal conditions and disorders. CONTACT: Advanced Spine Fixation Systems Inc., Irvine William E. Maya, 714/453-1290 |
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