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
PMAP050019
SupplementS032
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
S027
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
S020
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

NIH GUDID Devices

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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