CORDIS EXOSEAL VASCULAR CLOSURE DEVICE

FDA Premarket Approval P100013 S021

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

Approval for a change to the degreasing solution and system used in the manufacturing of the indicator wire component of the exoseal vascular closure device

DeviceCORDIS EXOSEAL VASCULAR CLOSURE DEVICE
Generic NameDevice, Hemostasis, Vascular
ApplicantCordis US Corporation
Date Received2021-09-10
Decision Date2021-09-28
PMAP100013
SupplementS021
Product CodeMGB 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Cordis US Corporation 14201 N.w. 60th Avenue miami Lakes, FL 33014

Supplemental Filings

Supplement NumberDateSupplement Type
P100013Original Filing
S021 2021-09-10 30-day Notice
S020 2019-05-24 30-day Notice
S019 2019-04-05 30-day Notice
S018 2019-02-28 30-day Notice
S017 2018-07-12 30-day Notice
S016
S015 2017-08-11 Normal 180 Day Track No User Fee
S014 2017-04-11 135 Review Track For 30-day Notice
S013 2016-06-02 30-day Notice
S012 2015-07-23 30-day Notice
S011
S010 2014-03-24 30-day Notice
S009 2013-04-09 30-day Notice
S008 2012-12-03 30-day Notice
S007 2012-11-13 30-day Notice
S006 2012-09-13 30-day Notice
S005 2012-07-16 30-day Notice
S004 2012-06-19 30-day Notice
S003 2011-12-12 Real-time Process
S002 2011-08-30 30-day Notice
S001 2011-07-28 30-day Notice

NIH GUDID Devices

Device IDPMASupp
20705032058893 P100013 010
20705032058879 P100013 010
20705032058855 P100013 010

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