XACT Carotid Stent System

FDA Premarket Approval P040038 S040

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

DeviceXACT Carotid Stent System
Generic NameStent, Carotid
ApplicantABBOTT VASCULAR INC.3200 Lakeside Drivesanta Clara, CA 95054 PMA NumberP040038 Supplement NumberS040 Date Received06/14/2022 Decision Date07/13/2022 Product Code NIM  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-06-14
Decision Date2022-07-13
PMAP040038
SupplementS040
Product CodeNIM 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressABBOTT VASCULAR INC.
3200 Lakeside Drive
santa Clara, CA 95054 PMA NumberP040038 Supplement NumberS040 Date Received06/14/2022 Decision Date07/13/2022 Product Code NIM  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
an Update To The On-line Sampling Plan And The Implementation Of Process Monitoring Alerts

Supplemental Filings

Supplement NumberDateSupplement Type
P040038Original Filing
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

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