1. Peripheral percutaneous transluminal angioplasty (PTA) and specialty catheters: premarket notification (510(k)) submissions : guidance for industry and Food and Drug Administration staff Publication: [Silver Spring, MD] : Center for Devices and Radiological Health, April 14, 2023 Subject(s): Angioplasty, Balloon, CoronaryCardiac CathetersDevice ApprovalGovernment RegulationUnited States