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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 Dr., Suite 160
Santa Clara, CA 95054
PMA NumberP120016
Supplement NumberS031
Date Received11/30/2022
Decision Date12/29/2023
Product Code MGB 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the addition of four sterilization sites located at Sterigenics, U.S., LLC: 1700 College Blvd. West Memphis, AR 72301; 1003 Lakeside Drive Gurnee, IL 60031; 1401 Morgan Cir. Tustin, CA 92780; 3125 Wichita Court Fort Worth, TX 76140
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