https://www.philips.com/a-w/about/news/archive/standard/news/press/2019/20190619-philips-receives-fda-premarket-approval-for-its-heartstart-onsite-and-heartstart-home-defibrillators
Philips receives FDA premarket approval for HeartStart AEDs - News | Philips
The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has approved Philips premarket approval (PMA) application for...
fda premarket approvalphilipsreceivesheartstartaeds
https://www.fda.gov/medical-devices/quality-and-compliance-medical-devices/medical-device-premarket-approval-and-postmarket-inspections-field-reporting-requirements
Medical Device Premarket Approval and Postmarket Inspections - Field Reporting Requirements | FDA
Compliance Program Guidance Manual 7383.001 for Medical Device Premarket Approval and Postmarket Inspections
medical devicepremarket approvalfield reporting
https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-approval-pma
Premarket Approval (PMA) | FDA
Device Advice - Overview of premarket approval process, including definitions from regulations, and other information necessary to submission of an application...
premarket approvalpmafda