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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.
 
DeviceVascade Vascular Closure System (VCS)
Generic NameDevice, hemostasis, vascular
ApplicantCardiva Medical, Inc.
2900 Lakeside Dr., Suite 160
Santa Clara, CA 95054
PMA NumberP120016
Supplement NumberS029
Date Received09/02/2022
Decision Date03/01/2023
Product Code MGB 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the following changes:1) Increase in disc deployment diameter from 23F to 25F;2) Increase in collagen mass from 12 mg to 19 mg;3) Modifications to certain device components to accommodate the new disc deployment diameter and collagen mass; and4) Modifications to the Instructions for Use to reflect the changes in device design.
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