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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
Generic NameDevice, hemostasis, vascular
ApplicantCARDIVA MEDICAL, INC.
2900 LAKESIDE DRIVE
SUITE 160
Santa Clara, CA 95054
PMA NumberP120016
Supplement NumberS006
Date Received09/29/2014
Decision Date10/23/2014
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  
REORGANIZATION OF TWO EXISTING MANUFACTURING STEPS AND A CHANGE OF LOCATION OF THE PROCESSES TO BE PERFORMED TO OUTSIDE OF A CONTROLLED ENVIRONMENT ROOM (CER).
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