PMA supplement

Different changes call for different supplement types, from 180-day supplements for significant design changes to 30-day notices for manufacturing changes. Planning changes early helps choose the right route and avoids shipping a modified device without approval.

PMA supplement means a supplemental application to an approved PMA for approval of a change or modification in a class III medical device, including all information submitted with or incorporated by reference therein.

21 CFR, 814.3