The U.S. Food & Drug Administration releases a list of pre-market approvals granted in November 2012.
Summary of PMA Originals & Supplements Approved
Summary of PMA Originals Under Review
Total Under Review: 49
Total Active: 18
Total On Hold: 31
Summary of PMA Supplements Under Review
Total Under Review: 640
Total Active: 480
Total On Hold: 160
Summary of All PMA Submissions Received
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
Covidien says it plans to get its recalled Pipeline brain embolism device back on the market...
Retractable Technologies urges a federal appeals court to deny Becton Dickinson's bid for a re-...
All new da Vinci systems will ship with Intuitive Surgical's newly cleared Firefly blood and tissue...
Invacare blames a poor 1st-half and "slow start" to Q3 for restructuring measures that will reduce...