XACT Carotid Stent System

Stent, Carotid

FDA Premarket Approval P040038 S035

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

Modification to the ethylene oxide sterilization dunnage configuration layers and pallet dimensions

DeviceXACT Carotid Stent System
Classification NameStent, Carotid
Generic NameStent, Carotid
ApplicantABBOTT VASCULAR INC.
Date Received2019-02-08
Decision Date2019-03-14
PMAP040038
SupplementS035
Product CodeNIM
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address ABBOTT VASCULAR INC. 3200 Lakeside Drive santa Clara, CA 95054

Supplemental Filings

Supplement NumberDateSupplement Type
P040038Original Filing
S041 2022-11-21 135 Review Track For 30-day Notice
S040 2022-06-14 30-day Notice
S039 2021-11-12 30-day Notice
S038 2021-10-29 30-day Notice
S037
S036 2020-08-06 30-day Notice
S035 2019-02-08 30-day Notice
S034 2019-01-24 30-day Notice
S033 2018-09-05 30-day Notice
S032 2017-09-28 135 Review Track For 30-day Notice
S031 2016-05-09 Normal 180 Day Track No User Fee
S030 2013-09-30 30-day Notice
S029 2013-05-14 30-day Notice
S028 2012-12-19 30-day Notice
S027 2012-06-13 30-day Notice
S026 2012-06-11 30-day Notice
S025 2012-05-24 30-day Notice
S024 2012-02-27 Normal 180 Day Track No User Fee
S023 2011-08-03 30-day Notice
S022 2011-08-02 30-day Notice
S021 2011-02-28 30-day Notice
S020 2009-10-21 30-day Notice
S019 2009-05-26 Normal 180 Day Track No User Fee
S018 2009-02-13 Normal 180 Day Track No User Fee
S017 2009-02-11 30-day Notice
S016 2009-02-09 Real-time Process
S015 2008-12-15 Normal 180 Day Track No User Fee
S014 2008-07-10 135 Review Track For 30-day Notice
S013 2008-06-09 135 Review Track For 30-day Notice
S012 2007-12-18 Normal 180 Day Track No User Fee
S011
S010 2007-03-02 30-day Notice
S009 2006-12-26 30-day Notice
S008 2006-12-18 Real-time Process
S007 2006-11-13 Normal 180 Day Track No User Fee
S006 2006-07-10 135 Review Track For 30-day Notice
S005
S004 2006-06-22 Special (immediate Track)
S003 2006-07-14 135 Review Track For 30-day Notice
S002 2006-06-19 30-day Notice
S001 2005-09-29 Normal 180 Day Track No User Fee

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.