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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
Classification Namedevice, hemostasis, vascular
Generic Namedevice, hemostasis, vascular
Applicant
Cardiva Medical, Inc.
2900 lakeside drive
suite 160
santa clara, CA 95054
PMA NumberP080029
Supplement NumberS001
Date Received08/18/2010
Decision Date03/11/2011
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR ERGONOMIC CHANGES TO THE QUICK-CLOSE VASCULAR SUTURING SYSTEM.
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