FDA releases October 2012 PMA approvals

December 27, 2012 by MassDevice staff

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

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Summary of PMA Originals & Supplements Approved
Originals: 7 
Supplements: 69

Summary of PMA Originals Under Review
Total Under Review: 51 
Total Active: 21 
Total On Hold: 30

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Summary of PMA Supplements Under Review
Total Under Review: 555 
Total Active: 392 
Total On Hold: 163

Summary of All PMA Submissions Received
Originals: 2 
Supplements: 71

Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 69 
Number of Denials: 0 
Average Days Fr Receipt to Decision (Total Time): 164 
FDA Time: 123.6 Days MFR Time: 40.4 Days