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    • Premarket Approvals (PMA)

    Metadata Updated: July 11, 2025

    Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated on a monthly basis.

    Access & Use Information

    Public: This dataset is intended for public access and use. License: See this page for license information.

    Downloads & Resources

    References

    http://www.fda.gov/medicaldevices/productsandmedicalprocedures/deviceapprovalsandclearances/pmaapprovals/default.htm
    http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm

    Dates

    Metadata Created Date November 10, 2020
    Metadata Updated Date July 11, 2025

    Metadata Source

    Harvested from Healthdata.gov

    Other Data Resources

    Additional Metadata

    Resource Type Dataset
    Metadata Created Date November 10, 2020
    Metadata Updated Date July 11, 2025
    Publisher U.S. Food and Drug Administration
    Maintainer
    Identifier 475907fb-6a5d-4ad8-90c0-b276edc05227
    Data First Published 2021-02-25
    Data Last Modified 2013-11-01
    Category FDA
    Public Access Level public
    Bureau Code 009:10
    Metadata Context https://project-open-data.cio.gov/v1.1/schema/catalog.jsonld
    Metadata Catalog ID https://healthdata.gov/data.json
    Schema Version https://project-open-data.cio.gov/v1.1/schema
    Catalog Describedby https://project-open-data.cio.gov/v1.1/schema/catalog.json
    Data Dictionary http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Databases/ucm135279.htm
    Harvest Object Id 4e97b043-bc56-4ccc-93ad-feb03584226e
    Harvest Source Id 651e43b2-321c-4e4c-b86a-835cfc342cb0
    Harvest Source Title Healthdata.gov
    Homepage URL https://healthdata.gov/d/798x-p6ne
    License http://opendefinition.org/licenses/odc-odbl/
    Program Code 009:005
    Related Documents http://www.fda.gov/medicaldevices/productsandmedicalprocedures/deviceapprovalsandclearances/pmaapprovals/default.htm, http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm
    Source Datajson Identifier True
    Source Hash 42ba3a4e9a711fa79ee7cfda5dc165d661301b12e51a676dc66b75465bf7a039
    Source Schema Version 1.1

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