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: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news
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