From: O'Grady, Judi [jogrady@integra-ls.com] Sent: Thursday, June 13, 2002 8:36 PM To: 'fdadockets@oc.fda.gov' Subject: Combination Products Meeting-June 24 Dear Ms. Wesley, Integra LifeSciences Corporation wishes to participate at the "Combination Products Containing Live Cellular Components Hearing" scheduled for June 24, 2002 Name of person participating: Judith E. O'Grady Sr. Vice President Regulatory Affairs Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536 Tel: 609-936-2311 Sponsor: Integra LifeSciences Corporation Integra LifeSciences is requesting approximately 15-20 minutes presentation time. We of course can present longer or shorter amount of time depending on FDA 's schedule and agenda. I can send FDA my entire presentation in advance. I will provide a brief summary . The presentation will focus on Integra LifeSciences product -INTEGRA Dermal Regeneration Template. INTEGRA is a skin replacement system for the treatment of full thickness or deep partial-thickness thermal injuries and repair of scar contractures. The FDA approved Indication for Use is: "INTEGRA Dermal Regeneration Template is indicated for the postexcisional treatment of life-threatening full-thickness or deep partial thickness thermal injury where sufficient autograft is not available at the time of excision or not desirable due to the physiological condition of the patient INTEGRA Dermal Regeneration template is also indicated for repair of scar contractures when other therapies have failed or when donor sites for repair are not sufficient or desirable due to the physiological condition of the patient." INTEGRA Dermal Regeneration Template is currently regulated as a Medical Device by CDRH.It is also regulated as a Medical Device in the European Union, Canada, Australia, Japan and all 30 countries where it is registered. The product is a bilayer matrix of collagen and glycosaminoglycan a. The product does not contain any cellular components, recombinant derived proteins or other components that would be regulated under the Center for Biologics. The PMA for INTEGRA Dermal Regeneration Template contained extensive safety and effectiveness data , including multicenter, controlled, randomized clinical trials, histological evaluations of the wound sites, immunological studies, biocompatability studies and long term follow up of one year. Conditions of approval included a 200 patient postapproval study, mandatory physician training, postmarket surveillance and annual reporting requirements. INTEGRA Dermal Regeneration Template has been approved by FDA for 6 years, and has over a 20 year history from the time of the first IDE of safety and effectiveness. The product should remain in the Center of Devices and Radiological Health as it is a Class II Medical Device and contains no cellular components.Extensive testing and controls are already in place for this device. Will we be able to present a power point presentation on the computer? Can we, or would FDA like us to show some case studies? Do you need more than this brief summary in advance? I can send the entire presentation next week by Federal Express-or E-mail. Please advise us on these points. We will cooperate in any way we can with this meeting. Thank you in advance for your consideration and cooperation. Best regards, Judi O'Grady Judith E. O'Grady Sr.Vice President Regulatory Affairs, Quality Assurance and Clinical Affairs Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536 Tel: 609-936-2311 FAX: 609-275-3684 jogrady@integra-LS.com <>