EXOSEAL® Vascular Closure

FDA Premarket Approval P100013 S026

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

DeviceEXOSEAL® Vascular Closure
Generic NameDevice, Hemostasis, Vascular
ApplicantCordis US Corporation14201 N.w. 60th Avenuemiami Lakes, FL 33014 PMA NumberP100013 Supplement NumberS026 Date Received10/21/2022 Decision Date10/28/2022 Product Code MGB  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-10-21
Decision Date2022-10-28
PMAP100013
SupplementS026
Product CodeMGB 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressCordis US Corporation
14201 N.w. 60th Avenue
miami Lakes, FL 33014 PMA NumberP100013 Supplement NumberS026 Date Received10/21/2022 Decision Date10/28/2022 Product Code MGB  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
for A Change To Paper Weight Used With For The EXOSEAL® IFU From 50 Lb To 40 Lb At Steri-Tek

Supplemental Filings

Supplement NumberDateSupplement Type
P100013Original Filing
S026 2022-10-21 30-day Notice
S025
S024 2022-01-31 30-day Notice
S023 2021-11-17 30-day Notice
S022 2021-10-27 30-day Notice
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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