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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namedevice, hemostasis, vascular
Generic Namedevice, hemostasis, vascular
888 w. maude ave
sunnyvale, CA 94085
PMA NumberP120016
Date Received08/03/2012
Decision Date01/31/2013
Product Code
MGB[ Registered Establishments with MGB ]
Docket Number 13M-0592
Notice Date 05/17/2013
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the vascade¿ vascular closure system (vcs). This device is indicated for femoral arterial access site closure while reducing times to hemostasis and ambulation in patients who haveundergone diagnostic or interventional endovascular procedures using a 5f, 6f, or 7f procedural sheath. The vascade vcs is also indicated to reduce time to discharge eligibility in patients who have undergone diagnostic endovascular procedures using a 5f, 6f, or 7f procedural sheath.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S015 S016 S017 S018 
S019 S020