Medtech approvals: FDA releases September 2015 PMAs

The FDA today released its list of the pre-market approvals it granted for medical devices in September 2015: Summary of PMA Originals & Supplements Approved Originals: 4 Supplements: 53 Summary of PMA Originals Under Review Total Under Review: 55 Total Active: 31 Total On Hold: 24 Summary of PMA Supplements Under Review Total Under Review: 611 Total Active: 461 Total On Hold: 150 Summary of All PMA Submissions Originals: 3 Supplements: 84 Summary of PMA Supplement PMA Approval/Denial Decision Times Number of Approvals: 53 Number of Denials: 0 Average Days Fr Receipt to Decision (Total Time): 127.6 FDA Time: 90.9 Days MFR Time: 36.9 Days PMA Original Approvals APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS P100006 9/1/15 Augment® Bone Graft Biomimetic Therapeutics, LLC Franklin, TN 37067 Approval for Augment® Bone Graft. This device is indicated for use as an alternative to autograft in arthrodesis (i.e., surgical fusion procedures) of the ankle (tibiotalar joint) and/or hindfoot (including subtalar, talonavicular, and calcaneocuboid joints, alone or in combination), due to osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, psoriatic arthritis, avascular necrosis, joint instability, joint deformity, congenital defect, or joint arthropathy in patients with preoperative or intraoperative evidence indicating the need for supplemental graft material. P140005 9/2/1...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news