The U.S. Food & Drug Administration releases a list of pre-market approvals granted in October 2012.
Summary of PMA Originals & Supplements Approved
Summary of PMA Originals Under Review
Total Under Review: 51
Total Active: 21
Total On Hold: 30
Summary of PMA Supplements Under Review
Total Under Review: 555
Total Active: 392
Total On Hold: 163
Summary of All PMA Submissions Received
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
The number of warning letters sent by the FDA last year to medical device companies fell for the 1st...
Shares of pSivida and Alimera Sciences jump after the FDA approves their Iluvien treatment for...
Intuitive Surgical says the FDA cleared a new robotic 'wrist' for hysterectomies and other...
Here's a look at some of the top legal news stories for medical device companies this week: Boston...
A federal appeals court vacates the FDA's decision to rescind its 510(k) clearance for ReGen...