QUICK-CLOSE VASCULAR SUTURING SYSTEM

FDA Premarket Approval P080029 S002

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.

Pre-market Approval Supplement Details

Change to the dimensional tolerances of the cannula and modifications to the bonding process for two device subassemblies.

DeviceQUICK-CLOSE VASCULAR SUTURING SYSTEM
Generic NameDevice, Hemostasis, Vascular
ApplicantCardiva Medical, Inc.
Date Received2014-11-26
Decision Date2014-12-18
PMAP080029
SupplementS002
Product CodeMGB 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Cardiva Medical, Inc. 2900 Lakeside Drive suite 160 santa Clara, CA 95054

Supplemental Filings

Supplement NumberDateSupplement Type
P080029Original Filing
S002 2014-11-26 30-day Notice
S001 2010-08-18 Normal 180 Day Track

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