AngioJet Rheolythic Thrombectomy Catheter System

FDA Premarket Approval P980037 S088

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

DeviceAngioJet Rheolythic Thrombectomy Catheter System
Generic NameCatheter, Coronary, Atherectomy
ApplicantBoston Scientific Corp.one Scimed Placemaple Grove, MN 55311-1566 PMA NumberP980037 Supplement NumberS088 Date Received04/07/2022 Decision Date05/06/2022 Product Code MCX  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-04-07
Decision Date2022-05-06
PMAP980037
SupplementS088
Product CodeMCX 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressBoston Scientific Corp.
one Scimed Place
maple Grove, MN 55311-1566 PMA NumberP980037 Supplement NumberS088 Date Received04/07/2022 Decision Date05/06/2022 Product Code MCX  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
to Process Devices Using The Reduced EtO S756 Sterilization Cycle At The BSC Coventry Rhode Island, BSC Galway Ireland, And Steris Tullamore Ireland Facilities

Supplemental Filings

Supplement NumberDateSupplement Type
P980037Original Filing
S088 2022-04-07 30-day Notice
S087 2022-02-04 30-day Notice
S086 2021-08-04 Normal 180 Day Track No User Fee
S085 2021-07-08 30-day Notice
S084 2020-12-03 30-day Notice
S083 2020-11-02 30-day Notice
S082 2020-10-16 30-day Notice
S081 2020-08-04 30-day Notice
S080 2020-03-16 30-day Notice
S079
S078 2020-01-30 Normal 180 Day Track No User Fee
S077 2019-11-22 30-day Notice
S076 2019-09-25 30-day Notice
S075 2019-06-27 30-day Notice
S074
S073 2019-04-29 Real-time Process
S072 2019-01-04 30-day Notice
S071 2018-10-24 30-day Notice
S070 2018-09-04 30-day Notice
S069 2018-01-12 30-day Notice
S068 2018-01-10 Special (immediate Track)
S067 2017-09-07 30-day Notice
S066 2017-07-18 Real-time Process
S065 2017-04-17 Normal 180 Day Track No User Fee
S064 2017-03-31 30-day Notice
S063 2017-01-09 30-day Notice
S062 2016-11-14 30-day Notice
S061 2016-11-02 30-day Notice
S060 2016-10-31 30-day Notice
S059 2016-10-20 135 Review Track For 30-day Notice
S058 2016-07-18 30-day Notice
S057 2016-03-07 Normal 180 Day Track No User Fee
S056 2016-01-14 30-day Notice
S055 2016-01-11 30-day Notice
S054 2015-11-27 30-day Notice
S053 2015-11-10 Normal 180 Day Track No User Fee
S052 2015-11-09 30-day Notice
S051 2015-11-05 30-day Notice
S050 2015-10-01 Normal 180 Day Track No User Fee
S049 2015-09-30 30-day Notice
S048 2015-08-21 30-day Notice
S047 2015-08-19 30-day Notice
S046 2015-06-18 135 Review Track For 30-day Notice
S045 2014-12-24 Real-time Process
S044 2014-11-18 135 Review Track For 30-day Notice
S043 2014-08-18 30-day Notice
S042 2014-06-03 Real-time Process
S041 2014-02-03 30-day Notice
S040 2012-08-15 Real-time Process
S039 2011-11-15 Normal 180 Day Track
S038 2011-07-05 Normal 180 Day Track
S037 2011-05-23 30-day Notice
S036 2011-05-20 Real-time Process
S035 2011-02-08 Real-time Process
S034 2011-01-18 Real-time Process
S033 2009-11-05 30-day Notice
S032 2009-06-10 Real-time Process
S031 2009-05-27 Real-time Process
S030 2009-04-27 Real-time Process
S029 2009-02-06 30-day Notice
S028 2009-01-27 30-day Notice
S027 2008-07-16 Normal 180 Day Track
S026 2008-07-07 30-day Notice
S025 2008-01-28 Real-time Process
S024 2007-12-20 Normal 180 Day Track
S023 2007-07-03 30-day Notice
S022 2007-03-05 Real-time Process
S021 2006-12-07 Real-time Process
S020 2006-09-29 Normal 180 Day Track
S019 2006-08-14 135 Review Track For 30-day Notice
S018
S017 2005-11-29 Real-time Process
S016 2005-10-17 Normal 180 Day Track
S015 2005-10-03 Real-time Process
S014 2005-08-01 Normal 180 Day Track
S013 2005-05-02 Real-time Process
S012 2005-01-07 30-day Notice
S011 2004-06-16 Special (immediate Track)
S010 2004-05-19 Real-time Process
S009 2004-05-19 Real-time Process
S008 2004-05-19 Real-time Process
S007 2003-11-26 Normal 180 Day Track
S006 2002-12-18 Special (immediate Track)
S005
S004 2001-01-31 Normal 180 Day Track
S003 2000-12-19 Normal 180 Day Track
S002 2000-02-29 Special (immediate Track)
S001 1999-11-02 Normal 180 Day Track

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.