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.
PMA Original Approvals
None.
PMA Supplemental Approvals
30-Day Notices (135 Day Supplement was not required)
Total Under Review: 50
Total Active:15
Total On Hold: 35
Summary of PMA Supplements Under Review
Total Under Review: 613
Total Active: 437
Total On Hold: 176
Summary of All PMA Submissions Received
Originals: 2
Supplements: 127
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 51
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 179
FDA Time: 161.5 Days MFR Time: 17.5 Days