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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