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

    Metadata Updated: March 16, 2021

    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.

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    Dates

    Metadata Created Date November 10, 2020
    Metadata Updated Date March 16, 2021
    Data Update Frequency R/P1W

    Metadata Source

    Harvested from Healthdata.gov

    Additional Metadata

    Resource Type Dataset
    Metadata Created Date November 10, 2020
    Metadata Updated Date March 16, 2021
    Publisher U.S. Food and Drug Administration
    Unique Identifier Unknown
    Maintainer
    Identifier 8dabbf7e-0e4a-4e1c-a0d2-982d97398a10
    Data First Published 2021-02-25
    Data Last Modified 2021-03-12
    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 0cdf99af-b7a3-4d66-8094-6dd3a06b66f0
    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 a3b11033adaeaa5f133e57fd3b70e53b01cd179a
    Source Schema Version 1.1

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