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

Metadata Updated: July 26, 2023

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.

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

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pmamemos.cfm

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Dates

Metadata Created Date	November 10, 2020
Metadata Updated Date	July 26, 2023
Data Update Frequency	R/P1W

Metadata Source

Data.json Data.json Metadata
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Harvested from Healthdata.gov

Additional Metadata

Resource Type	Dataset
Metadata Created Date	November 10, 2020
Metadata Updated Date	July 26, 2023
Publisher	U.S. Food and Drug Administration
Maintainer	openFDA
Identifier	8dabbf7e-0e4a-4e1c-a0d2-982d97398a10
Data First Published	2021-02-25
Data Last Modified	2023-07-26
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	a1eb88c3-5f93-4c47-a6b0-caa10b510106
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	41fdeadbd17e2edbe016da32150dc1720cdd401c
Source Schema Version	1.1

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