What Does PMN Stand For?

PMN stands for Device Premarket Notification Number 510k ORA

PMN, or Device Premarket Notification Number 510k ORA AofC Code, refers to the unique identifier assigned to a medical device submitted under the 510(k) premarket notification process. This code signifies the regulatory status of the device, indicating that it has been reviewed and deemed substantially equivalent to a legally marketed predicate device. The PMN is essential for manufacturers to ensure compliance with FDA regulations and facilitate market entry for their medical devices.

Other Meanings for PMN