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    • Premarket Approvals (PMA)

    Metadata Updated: March 16, 2021

    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 March 16, 2021

    Metadata Source

    Harvested from Healthdata.gov

    Other Data Resources

    Additional Metadata

    Resource Type Dataset
    Metadata Created Date November 10, 2020
    Metadata Updated Date March 16, 2021
    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
    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 38574206-cf45-44f2-a8d6-c433c48b685e
    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 e4db267d909e20d81e3a0643e921420edd291c31
    Source Schema Version 1.1

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