DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 208069 NADA 141446 DEEMED GRANTED MEDICAL GAS CERTIFICATION REQUEST Strata Medical Innovations Attn: Mark Aldana President 3706 76th Street Lubbock, TX 79423 Dear Mr. Aldana: Please refer to your September 22, 2014 request received on September 26, 2015, for certification of Nitrous Oxide, USP as a designated medical gas. You have requested to market Nitrous Oxide, USP for human and animal drug use. A request for certification of a medical gas as a designated medical gas submitted under section 575(a)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) is deemed to be granted unless, within 60 days of the filing of the request, FDA finds that one or more of the bases for denying the request listed at section 575(a)(2) of the FD&C Act applies. FDA has made no such finding in connection with your request, and 60 days have passed since your request was filed. Accordingly, by operation of section 575(a)(2) of the FD&C Act, your request for certification of Nitrous Oxide, USP as a designated medical gas is deemed to be granted, and you now have in effect an approved new drug application (NDA 208069) and an approved new animal drug application (NADA 141446) for this gas. If any of the information you have submitted in connection with your request becomes incomplete or inaccurate, please consult section IV.D of the draft guidance document entitled Certification Process for Designated Medical Gases (available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U CM332136.pdf) for instructions on providing FDA with complete, up-to-date information. Please address any such communications to: Food and Drug Administration Center for Drug Evaluation and Research Office of Pharmaceutical Quality 5901-B Ammendale Road Beltsville, MD 20705-1266 Please include the NDA and NADA numbers listed above at the top of the first page of any such communications. Reference ID: 3831550 NDA 208069 NADA 141446 Page 2 If you have any questions, please contact Michael Folkendt at (301) 796-1670 or by email at michael.folkendt@fda.hhs.gov. Sincerely, {See appended electronic signature page} Charles J. Andres, Ph.D. Business Process Improvement Manager Office of New Animal Drug Evaluation, Center for Veterinary Medicine FDA Reference ID: 3831550 Michael Folkendt Associate Director for Regulatory Affairs Office of Program and Regulatory Operations Office of Pharmaceutical Quality Center for Drug Evaluation and Research FDA --------------------------------------------------------------------------------------------------------This is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature. --------------------------------------------------------------------------------------------------------/s/ ---------------------------------------------------MICHAEL M FOLKENDT 10/09/2015 CHARLES J ANDRES 10/12/2015 Reference ID: 3831550 (