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Medtech approvals: FDA releases June 2015 PMAs
The FDA today released its list of the pre-market approvals it granted for medical devices in June 2015:
Summary of PMA Originals & Supplements Approved
Originals: 5
Supplements: 80
Summary of PMA Originals Under Review
Total Under Review: 53
Total Active: 22
Total On Hold: 31
Summary of PMA Supplements Under Review
Total Under Review: 575
Total Active: 418
Total On Hold: 157
Summary of All PMA Submissions
Originals: 4
Supplements: 72
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 80
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 115.2
FDA Time: 97.1 ...
Source: Mass Device - August 20, 2015 Category: Medical Equipment Authors: MassDevice Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news
