Medtech approvals: FDA releases December 2015 PMAs
The Food & Drug Administration today released a list of pre-market approvals granted in December 2015: Summary of PMA Originals & Supplements Approved Originals: 2 Supplements: 81 Summary of PMA Originals Under Review Total Under Review: 58 Total Active: 32 Total On Hold: 26 Summary of PMA Supplements Under Review Total Under Review: 599 Total Active: 423 Total On Hold: 176 Summary of All PMA Submissions Originals: 3 Supplements: 92 Summary of PMA Supplement PMA Approval/Denial Decision Times Number of Approvals: 81 Number of Denials: 0 Average Days Fr Receipt to Decision (Total Time): 163.1 FDA Time: 140.4 Days MFR Time: 22.7 Days PMA Original Approvals APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS P140030 12/17/15 Astron Peripheral Self-Expanding Nitinol Stent System Biotronik, Inc. Lake Oswego, OR 97035 Approval for the Astron Peripheral Self-Expanding Stent System. This device is indicated for improving luminal diameter in patients with iliac atherosclerotic lesions in vessel reference diameters between 4.3mm and 9.5mm and lesion lengths up to 105mm. P150019 12/7/15 Paradigm Real-Time Revel System Medtronic MiniMed Northridge, CA 91325 Approval for the Paradigm Real-Time Revel System. This device is indicated for: Paradigm REAL-Time Revel insulin pump. The Paradigm REAL-Time Revel insulin pumps (MMT-523/MMT-723) are indicated for the continuous delivery of insulin,...
Source: Mass Device - Category: Medical Equipment Authors: MassDevice Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news
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