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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.
 
DeviceQUICK-CLOSE VASCULAR SUTURING SYSTEM
Generic NameDevice, hemostasis, vascular
ApplicantCardiva Medical, Inc.
2900 Lakeside Dr., Suite 160
Santa Clara, CA 95054
PMA NumberP080029
Supplement NumberS002
Date Received11/26/2014
Decision Date12/18/2014
Withdrawal Date05/06/2025
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  
CHANGE TO THE DIMENSIONAL TOLERANCES OF THE CANNULA AND MODIFICATIONS TO THE BONDING PROCESS FOR TWO DEVICE SUBASSEMBLIES.
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