FDA REQUIRES ADDITIONAL INFORMATION TO COMPLETE OSTEOPORT PMA APPLICATION REVIEW.SAN ANTONIO--(BUSINESS WIRE)--May 9, 1995--- LifeQuest Medical, Inc. (NASDAQ/NMS: LQMD) announced that 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. has informed the Company that additional information will be required to enable completion of the Osteoport 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 review. Required information may include clarifications and further analysis of existing data and/or additional patient studies. LifeQuest believes that the Osteoport device offers an important option for patients in whom no reasonable alternative for vascular access vascular access Clinical medicine The ability to enter the vascular system; the ease with which the vascular system can be entered for administering therapy or obtaining blood for testing exists. The research program leading to LifeQuest's PMA application for the Osteoport device was developed in close collaboration with the FDA. The Company intends to work expeditiously ex·pe·di·tious adj. Acting or done with speed and efficiency. See Synonyms at fast1. ex with the Agency to clarify the outstanding matters in order to resolve them. LifeQuest Medical is engaged in the commercialization of proprietary medical devices, including the Osteoport, a patented implantable device that utilizes the bone marrow to facilitate long-term drug treatment in cancer and AIDS patients, and the First-Med system, a patented intraosseous injection In medicine, intraosseous injection is the method of injecting a drug or other substance directly into the bone marrow cavity of pediatric (and occasionally adult) patients through an apparatus known as a free-flowing intraosseous infusion system. device for use in emergency situations. The Company is also developing the Introport accessing catheter, designed primarily for introducing catheters into implanted ports, including the Osteoport device. ValQuest Medical, LifeQuest's 55% owned subsidiary, has exclusive worldwide rights to all medical applications of Valdor Fiber Optics' patented fiber optic connector technology, which provide opportunities for LifeQuest to develop other proprietary oncology products as well as provide critical components to current and future corporate customers. CONTACT: LifeQuest Medical Herb Spoon, 210/366-2100 |
|
||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion