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
Here's a look at some of the top regulatory stories for medical device companies this week.
Ulthera, which makes an ultrasound device designed to lift lax tissue on the neck and under the chin...
Dr. George Bakris, co-principal investigator in Medtronic's Symplicity-3 trial, says renal...
Delivering Medical Extrusions in 3-5 days - Fast & Flexible
A federal appeals court stays a ban on U.S. sales of Medtronic's CoreValve replacement heart valve...