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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 Family
Generic NameDevice, hemostasis, vascular
ApplicantCARDIVA MEDICAL, INC.
2900 LAKESIDE DRIVE
SUITE 160
Santa Clara, CA 95054
PMA NumberP120016
Supplement NumberS034
Date Received12/05/2023
Decision Date01/03/2024
Product Code MGB 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
an additional controlled environment room at the approved Guaymas facility (Sonora, Mexico) for the Cardiva Vascade Family
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