The FDA’S Circulatory System Device Panel is recommending that percutaneous transluminal coronary angioplasty (PCTA) catheters be reclassified from class III (premarket approvals) to class II (special controls), following a petition made by the Cook Group.
A PTCA catheter is a device that operates on the principle of hydraulic pressurisation applied through an inflatable balloon attached...
Welcome to Medtech Insight
Create an account to read this article
Already a subscriber?