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Medtech approvals: FDA releases October 2015 PMAs

The FDA today released its list of the pre-market approvals it granted for medical devices in October 2015: Summary of PMA Originals &Supplements Approved Originals: 9 Supplements: 133 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: 597 Total Active: 433 Total On Hold: 164 Summary of All PMA Submissions Originals: 7 Supplements: 74 Summary of PMA Supplement PMA Approval/Denial Decision Times Number of Approvals: 133 Number of Denials: 0 Average Days Fr Receipt to Decision (Total Time): 161.5 FDA Time: 97.9 Days MFR Time: 63.6 Days PMA Original Approvals APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, &ZIP DEVICE DESCRIPTION / INDICATIONS P150003 10/2/15 SYNERGY™ Everolimus-Eluting Platinum Chromium Coronary Stent System Boston Scientific Corporation Maple Grove, MN 55311 Approval for the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System. This device is indicated for improving luminal diameter in patients with symptomatic heart disease, stable angina, unstable angina, non-ST elevation MI or documented silent ischemia due to atherosclerotic lesions in native coronary arteries ≥2.25 mm to ≤4.0 mm in diameter in lesions ≤34 mm in length. P150013 10/2/15 PD-L1 IHC 22C3 pharmDx Dako North America, Inc. Carpinteria, CA 93013 Approval for the PD-L1 IHC 22C3 pharmDx. This device is...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news

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