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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCardiva VASCADE Vascular Closure System (VCS)
Generic NameDevice, hemostasis, vascular
ApplicantCARDIVA MEDICAL, INC.
2900 LAKESIDE DRIVE
SUITE 160
Santa Clara, CA 95054
PMA NumberP120016
Supplement NumberS026
Date Received11/23/2018
Decision Date02/05/2019
Product Code MGB 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for changing your California headquarters facility to 1615 Wyatt Dr., Santa Clara, California, for the VASCADE Vascular Closure System (VCS) 700-500DX, 70-580I, 800-612C devices.
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