Carotid Wallstent™ Monorail Endoprosthesis

FDA Premarket Approval P050019 S032

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

An alternate adhesive to bond the stent holder to distal inner shaft

DeviceCarotid Wallstent™ Monorail Endoprosthesis
Generic NameStent, Carotid
ApplicantBoston Scientific Corp.
Date Received2021-10-19
Decision Date2021-11-15
Product CodeNIM 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Boston Scientific Corp. three Scimed Place maple Grove, MN 55311-1566

Supplemental Filings

Supplement NumberDateSupplement Type
P050019Original Filing
S032 2021-10-19 30-day Notice
S031 2019-06-27 30-day Notice
S030 2018-02-21 30-day Notice
S029 2018-01-26 30-day Notice
S028 2017-06-19 30-day Notice
S026 2016-11-14 30-day Notice
S025 2016-07-13 30-day Notice
S024 2016-02-25 30-day Notice
S023 2015-11-20 30-day Notice
S022 2015-11-19 30-day Notice
S021 2015-02-23 Real-time Process
S019 2013-09-27 30-day Notice
S018 2013-09-20 30-day Notice
S017 2013-08-29 30-day Notice
S016 2013-06-19 30-day Notice
S015 2013-06-10 30-day Notice
S014 2013-05-28 30-day Notice
S013 2013-02-04 30-day Notice
S012 2012-11-19 30-day Notice
S011 2012-11-01 30-day Notice
S010 2012-08-13 30-day Notice
S009 2012-06-13 30-day Notice
S008 2011-07-15 Normal 180 Day Track No User Fee
S007 2011-04-01 30-day Notice
S006 2010-10-07 Normal 180 Day Track No User Fee
S005 2010-04-08 135 Review Track For 30-day Notice
S004 2010-02-01 Normal 180 Day Track
S003 2010-01-26 30-day Notice
S002 2009-12-15 30-day Notice
S001 2009-05-19 Normal 180 Day Track No User Fee


Device IDPMASupp
08714729781226 P050019 000
08714729781202 P050019 000
08714729781189 P050019 000
08714729781165 P050019 000
08714729781141 P050019 000
08714729781127 P050019 000
08714729781103 P050019 000

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