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  2. Premarket Approval (PMA) - Food and Drug Administration

    www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm

    Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.

  3. PMA Approvals | FDA - U.S. Food and Drug Administration

    www.fda.gov/medical-devices/device-approvals-and-clearances/pma-approvals

    An approved Premarket Approval Application (PMA) -- like an approved New Drug Application (NDA) -- is, in effect, a private license granted to the applicant for marketing a particular medical...

  4. Medical Device Databases | FDA

    www.fda.gov/.../medical-device-databases

    The Total Product Life Cycle (TPLC) database integrates premarket and postmarket data about medical devices. It includes information pulled from CDRH databases including Premarket Approvals...

  5. Premarket Approval (PMA) | FDA - U.S. Food and Drug...

    www.fda.gov/.../premarket-approval-pma

    Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.

  6. The PMA dataset contains details about specific products and the sponsors of premarket approval applications and supplements. It also contains administrative and tracking information about...

  7. Premarket Approval (PMA) is the most stringent type of device marketing application required by FDA. A PMA is an application submitted to FDA to request approval to market.

  8. Premarket Approval (PMA) - Food and Drug Administration

    www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pmasimplesearch.cfm

    Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.

  9. Device Approvals and Clearances | FDA - U.S. Food and Drug...

    www.fda.gov/medical-devices/products-and-medical-procedures/device-approvals...

    Search the 510(k) Database; Premarket Approval (PMA) is the most stringent type of device marketing application required by FDA. A PMA is an application submitted to FDA to request approval to...

  10. FDA Premarket Approval Application - NBER

    www.nber.org/research/data/fda-premarket-approval-application

    The complete FDA Premarket Approval Application (PMA) database is offered here in SAS, Stata, and CSV formats to make the whole database a bit easier to use. > 98% of all Premarket Approval Application records are all plain, ASCII characters.

  11. The FDA PMA database is a good starting point as you prepare for your PMA approval prep work. Visit it to check out approved devices, connected data, attached documents from the submission process, and more.