FDA releases September 2012 PMA approvals

November 30, 2012 by MassDevice staff

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

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Summary of PMA Originals & Supplements Approved
Originals: 4 
Supplements: 78

Summary of PMA Originals Under Review
Total Under Review: 57 
Total Active: 30 
Total On Hold: 27 
Number Greater Than 180 Days: 1

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Summary of PMA Supplements Under Review
Total Under Review: 581 
Total Active: 443 
Total On Hold: 138 
Number Greater Than 180 Days: 5

Summary of All PMA Submissions Received
Originals: 0 
Supplements: 57

Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 78 
Number of Denials: 0 
Average Days Fr Receipt to Decision (Total Time): 145.7 
FDA Time: 104.9 Days MFR Time: 40.8 Days