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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
DeviceMANTA Vascular Closure Device
Generic Namedevice, hemostasis, vascular
Essential Medical, Inc.
260 sierra drive
suite 120
exton, PA 19341
PMA NumberP180025
Date Received07/09/2018
Decision Date02/01/2019
Product Code MGB 
Docket Number 19M-2526
Notice Date 04/03/2019
Advisory Committee Cardiovascular
Clinical Trials NCT02908880
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the 14F MANTA Vascular Closure Device. The device is indicated for closure of femoral arterial access sites following the use of 10-14F devices or sheaths (maximum OD/profile of 18F), and the 18F MANTA Vascular Closure Device is indicated for closure of femoral arterial access sites following the use of 15-18F devices or sheaths (maximum OD/profile of 25F).
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Supplements:  S001 S002 S005 S006 S007 S008 S009