AngioJet Rheolythic Thrombectomy Catheter

FDA Premarket Approval P980037 S078

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

Approval for the addition of a manufacturing site located at synergy health ast, srl, in alajuela, costa rica to perform contract sterilization

DeviceAngioJet Rheolythic Thrombectomy Catheter
Generic NameCatheter, Coronary, Atherectomy
ApplicantBoston Scientific Corp.
Date Received2020-01-30
Decision Date2020-05-05
Product CodeMCX 
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLocation Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Boston Scientific Corp. one Scimed Place maple Grove, MN 55311-1566

Supplemental Filings

Supplement NumberDateSupplement Type
P980037Original Filing
S080 2020-03-16 30-day Notice
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
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
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)
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

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