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 indicate...
Source: Mass Device - Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news
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