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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 5F Vascular Closure System
Generic NameDevice, hemostasis, vascular
ApplicantCardiva Medical, Inc.
2900 Lakeside Dr., Suite 160
Santa Clara, CA 95054
PMA NumberP120016
Supplement NumberS043
Date Received08/12/2026
Decision Date09/10/2026
Product Code MGB 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
an additional supplier for the collagen plug component of the VASCADE 5F (Model 700-500DX)
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