P210016 Safety Effectiveness Summary

FDA published a Final Order for Premarket Approval P210016, marking the completion of the agency's premarket review for a Class III medical device. The Safety Effectiveness Summary documents the FDA's determination that the device has demonstrated reasonable assurance of safety and effectiveness for its intended use. This order authorizes the device for commercial distribution in the United States.

Manufacturers with pending or future PMA applications should ensure their safety and effectiveness data packages align with FDA's review standards demonstrated in this order. Healthcare providers and facilities should be aware that this Class III device has received full market authorization through the most stringent FDA review pathway.