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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 Dr., Suite 160
Santa Clara, CA 95054
PMA NumberP120016
Supplement NumberS016
Date Received06/29/2015
Decision Date07/29/2015
Product Code MGB 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A LABELING CHANGE FOR THE IMPLEMENTATION OF AN ALTERNATIVE TECHNIQUE FOR RELEASE OF COLLAGEN FROM THE VASCADE DEVICE.
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