PMA means a Premarket Approval Application filed with the Food and Drug Administration pursuant to 21 C.F.R. Part 814.
PMA means premarket approval, the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices, and any de novo classification or Evaluation of Automatic Class III Designation with the FDA.
PMA means a Premarketing Approval application, as defined in 21 C.F.R. Part 814 in the United States (as it may be amended, supplemented or replaced from time to time), or equivalent application to any Competent Authority of any other country in the Territory, to commence commercial sale and marketing of a medical device for human use, including but not limited to any amendments, supplements, or supporting correspondence with respect thereto.