FDA releases November 2012 PMA approvals

January 11, 2013 by MassDevice staff

The U.S. Food & Drug Administration releases a list of pre-market approvals granted in November 2012.

FDA logo

Summary of PMA Originals & Supplements Approved
Originals: 4 
Supplements: 92

Summary of PMA Originals Under Review
Total Under Review: 49 
Total Active: 18 
Total On Hold: 31

Sign up to get our free newsletters delivered right to your inbox.

Summary of PMA Supplements Under Review
Total Under Review: 640 
Total Active: 480 
Total On Hold: 160

Summary of All PMA Submissions Received
Originals: 3 
Supplements: 82

Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 92 
Number of Denials: 0 
Average Days Fr Receipt to Decision (Total Time): 140 
FDA Time: 98.7 Days MFR Time: 41.3 Days