Premarket Approval (PMA)
PMA is the process of scientific and regulatory review for evaluating the safety and effectiveness of Class lll medical devices by FDA.
Class lll devices are those that support human life, and therefore FDA has determined that Class lll devices require (PMA) application in order to obtain marketing clearance.
visit:
https://www.fda.gov/medical-devices/premarket-approval-pma/pma-guidance-documents