FDA releases November 2012 PMA approvals

January 11, 2013 by MassDevice staff

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

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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

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