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

Metadata Updated: November 10, 2020

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 November 10, 2020

Metadata Source

Harvested from Healthdata.gov

Additional Metadata

Resource Type Dataset
Metadata Created Date November 10, 2020
Metadata Updated Date November 10, 2020
Publisher Department of Health & Human Services
Unique Identifier Unknown
Maintainer
Identifier 8ec55d4b-1218-4605-8626-88834e0ba8af
Data First Published 2015-03-31
Data Last Modified 2016-04-05
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
Homepage URL https://healthdata.gov/dataset/premarket-approval-pma-summary-review-memos-180-day-design-changes
License https://opendatacommons.org/licenses/odbl/1.0/
Program Code 009:005
Source Datajson Identifier True
Source Hash 2d10cf61ee8170edfa3822d8e9ed757d30a96394
Source Schema Version 1.1

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