Premarket Approvals (PMA)

Metadata Updated: March 16, 2021

Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated on a monthly basis.

Access & Use Information

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

Downloads & Resources

References

http://www.fda.gov/medicaldevices/productsandmedicalprocedures/deviceapprovalsandclearances/pmaapprovals/default.htm
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm

Dates

Metadata Created Date November 10, 2020
Metadata Updated Date March 16, 2021

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 475907fb-6a5d-4ad8-90c0-b276edc05227
Data First Published 2021-02-25
Data Last Modified 2013-11-01
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
Data Dictionary http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Databases/ucm135279.htm
Harvest Object Id 38574206-cf45-44f2-a8d6-c433c48b685e
Harvest Source Id 651e43b2-321c-4e4c-b86a-835cfc342cb0
Harvest Source Title Healthdata.gov
Homepage URL https://healthdata.gov/d/798x-p6ne
License http://opendefinition.org/licenses/odc-odbl/
Program Code 009:005
Related Documents http://www.fda.gov/medicaldevices/productsandmedicalprocedures/deviceapprovalsandclearances/pmaapprovals/default.htm, http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm
Source Datajson Identifier True
Source Hash e4db267d909e20d81e3a0643e921420edd291c31
Source Schema Version 1.1

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