Medtech approvals: FDA releases August 2015 PMAs

The FDA today released its list of the pre-market approvals it granted for medical devices in August 2015: Summary of PMA Originals &Supplements Approved Originals: 2 Supplements: 70 Summary of PMA Originals Under Review Total Under Review: 57 Total Active: 28 Total On Hold: 29 Summary of PMA Supplements Under Review Total Under Review: 569 Total Active: 422 Total On Hold: 147 Summary of All PMA Submissions Originals: 5 Supplements: 90 Summary of PMA Supplement PMA Approval/Denial Decision Times Number of Approvals: 70 Number of Denials: 0 Average Days Fr Receipt to Decision (Total Time): 229.0 FDA Time: 130.3 Days MFR Time: 98.7 Days PMA Original Approvals APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, &ZIP DEVICE DESCRIPTION / INDICATIONS P140008 8/5/15 Orbera™ Intragastric Balloon Apollo Endosurgery, Inc. Austin, TX 78746 Approval for the Orbera Intragastric Balloon. The ORBERA™ Intragastric Balloon System is indicated for use as an adjunct to weight reduction for adults with obesity with Body Mass Index (BMI) of ≥ 30 and ≤ 40 kg/m2 and is to be used in conjunction with a long-term supervised diet and behavior modification program designed to increase the possibility of significant long-term weight loss and maintenance of that weight loss. ORBERA™ is indicated for adult patients who have failed more conservative weight reduction alternatives, such as supervised diet, exercise and beha...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Food & Drug Administration (FDA) Pre-Market Approval (PMA) Regulatory/Compliance Source Type: news

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