Advanced Neuromodulation Systems Submits to the FDA the Final Module of Its PMA Application for Its Totally Implantable Pulse Generator.Business Editors DALLAS--(BUSINESS WIRE)--May 29, 2001 Advanced Neuromodulation Systems Inc. (ANS (ANS Communications, Inc, Purchase, NY) An ISP, Internet backbone and provider of private data network services, founded in 1990 as Advanced Network & Services, Inc., by IBM, MCI and Merit (consortium of Michigan universities). ) (Nasdaq:ANSI (American National Standards Institute, New York, www.ansi.org) A membership organization founded in 1918 that coordinates the development of U.S. voluntary national standards in both the private and public sectors. It is the U.S. member body to ISO and IEC. ) today announced that it has submitted to the 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. the second and final module of the premarket approval (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 ANS' Totally Implantable Pulse Generator implantable pulse generator Cardiac pacing A pacemaker used for permanent pacing, which is placed inside a pocket under the skin; the leads are positioned in or on the heart (IPG IPG Implantable pulse generator, see there ) Spinal Cord Stimulator Spinal Cord Stimulator (SCS) or Dorsal Column Stimulator (DCS) is an implantable medical device used to treat chronic pain of neurologic origin. An electric impulse generated by the device near the dorsal surface of the spinal cord provides a paresthesia ("tingling") for relief of chronic pain of the trunk and/or limbs. Chris Chavez, president and chief executive officer of ANS, said, "While we remain cautious, we continue to be encouraged by the positive dialogue and constructive comments we have received from the FDA regarding ANS' approach to demonstrating the safety and effectiveness of our IPG." He explained that after a company submits a PMA application, the FDA has up to 45 days to accept or reject the application for review. Within 100 days from the submission of a PMA application, a company is entitled to a meeting with the agency to determine the status of the application. By law, the FDA has up to 180 days from today to review and respond to ANS' PMA filing. On a parallel track, Chavez said that ANS is continuing to seek administrative review of the FDA's Feb. 23, 2001, reclassification petition denial letter as a prelude to ANS' continuing effort to appeal the denial of its reclassification petition. About Advanced Neuromodulation Systems Advanced Neuromodulation Systems designs, develops, manufactures and markets implantable systems used to manage chronic intractable pain and other disorders of the central nervous system. Additional information is available at www.ans-medical.com. "Safe harbor" statement under the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995: Statements contained in this document that are not based on historical facts are "forward-looking statements." Terms such as "plan," "should," "would," "anticipate," "believe," "intend," "estimate," "expect," "predict," "scheduled," "new market," "potential market applications" and similar expressions are intended to identify forward-looking statements. Such statements are by nature subject to uncertainties and risks, including but not limited to: completion of research and development projects in an efficient and timely manner; obtaining regulatory approvals on a timely and cost-efficient basis to permit the introduction of new products; the satisfactory completion of clinical trials and/or market tests prior to the introduction of new products; the adequacy, acceptability and timeliness of component supply; the approval of new products by reimbursement agencies like insurance companies, HMOs, Medicare and Medicaid Medicare and Medicaid U.S. government programs in effect since 1966. Medicare covers most people 65 or older and those with long-term disabilities. Part A, a hospital insurance plan, also pays for home health visits and hospice care. ; the efficacy of the company's products for new applications; and other risks detailed from time to time in the company's Securities and Exchange Commission filings. Consequently, if such management assumptions prove to be incorrect, or such risks or uncertainties materialize, anticipated results could differ materially from those forecast in forward-looking statements. |
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