Fda devices

FDA CDRH Medical Device Premarket Databases (510(k), PMA, De Novo) (infores:fda-devices)

Status: released

Knowledge Level: knowledge_assertion

Agent Type: manual_agent

Description: The FDA Center for Devices and Radiological Health records of premarket notifications (510(k)), premarket approvals (PMA) and De Novo classifications, with applicant, device and decision documents.

Cross References:

• https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm
• https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm

Consumed by:

• infores:lunasai-kg