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    • Premarket Approval (PMA) Summary Review Memos for 180-Day Design Changes

    Metadata Updated: July 17, 2025

    A 180-day supplement is a request for a significant change in components, materials, design, specification, software, color additive, and labeling to an approved premarket application or premarket report. As a pilot program under the CDRH Transparency Initiative, FDA has begun releasing some summary review memos for 180-day PMA supplements relating to design changes.

    Access & Use Information

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

    Downloads & Resources

    Dates

    Metadata Created Date November 10, 2020
    Metadata Updated Date July 17, 2025
    Data Update Frequency R/P1W

    Metadata Source

    Harvested from Healthdata.gov

    Other Data Resources

    Additional Metadata

    Resource Type Dataset
    Metadata Created Date November 10, 2020
    Metadata Updated Date July 17, 2025
    Publisher U.S. Food and Drug Administration
    Maintainer
    Identifier 8dabbf7e-0e4a-4e1c-a0d2-982d97398a10
    Data First Published 2021-02-25
    Data Last Modified 2025-07-16
    Category FDA
    Public Access Level public
    Data Update Frequency R/P1W
    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
    Harvest Object Id f5abe47f-c9fd-46c5-8b99-901ea2c8e43c
    Harvest Source Id 651e43b2-321c-4e4c-b86a-835cfc342cb0
    Harvest Source Title Healthdata.gov
    Homepage URL http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pmamemos.cfm
    License http://opendefinition.org/licenses/odc-odbl/
    Program Code 009:005
    Source Datajson Identifier True
    Source Hash 79e7c5a8a9fb5a1a0652f72f0863a213abf64a27678e4bce24cfe53582422870
    Source Schema Version 1.1

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