Below are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions. This list is generated on a monthly basis.
A PDF document that contains the "Approval letter and Summary of Safety and Effectiveness" is being added to this listing for each PMA. The PMA number will appear as a link if this document is available.
Summary of PMA Originals & Supplements Approved
Summary of PMA Originals Under Review
Summary of PMA Supplements Under Review
Summary of All PMA Submissions Received
Summary of PMA Supplement PMA Approval/Denial Decision Times